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Compensation claims after knee cartilage surgery is rare. A registry-based study from Scandinavia from 2010 to 2015

Compensation claims after knee cartilage surgery is rare. A registry-based study from Scandinavia... Background: Focal cartilage defects (FCDs) in the knee joint has a high prevalence. A broad range of treatment options exists for symptomatic patients. Knowledge of patient compensation claims following surgical treatment of FCDs is missing. The purpose of this study is to evaluate compensation claims filed to the Scandinavian registries for patient compensation following treatment of FCDs in the knee joint from 2010 to 2015 and identify possible areas of improvement. Methods: A cross-sectional study design was used to obtain all complaints following surgical treatment of FCDs from the Scandinavian registries from 2010 to 2015. Data such as age, gender, type of treatment, type of complaint, reason of verdict and amount of compensation were collected and systematically analyzed. Results: 103 patients filed a compensation claim. 43 had received debridement (41.7%), 54 microfracture (MF) (52.4%), 3 mosaicplasty (2.9%) and 3 autologous chondrocyte implantation (ACI) (2.9%). Of the 103 claims, 36 were granted (35%). 21 following debridement (58.3%), 13 after MF (36.1%), 1 following mosaicplasty (2.8%) and 1 after ACI (2.8%). The most common reason for complaint was infection (22.1%), of which 89% were granted. The average compensation was €24.457 (range €209 –€458.943). Conclusion: Compensation claims following surgical treatment of knee cartilage injuries in Scandinavia are rare. Establishing nationwide cartilage registries can add further knowledge on this troublesome disease. Keywords: Articular cartilage, Microfracture, Autologous chondrocyte implantation, Compensation claim Background osteoarthritis [4, 5]. Surgical treatment relieves symp- Focal cartilage defects (FCDs) in the knee joint is a high toms, but regardless of surgical procedure, the majority prevalence injury that may cause pain and reduced func- of patients do not achieve normal knee function [6–8]. tion, with the risk of early onset osteoarthritis [1–3]. No method or treatment has proved to be superior to Various surgical treatment options are available. The any other, and there is currently no gold standard or goal of operative treatment is to restore the articular car- consensus on what constitutes the best treatment for tilage and reduce symptoms and minimizing the risk of FCDs of the knee [9–11]. Orthopedic surgery is one of the medical specialties * Correspondence: tommy.aae@gmail.com with the highest rate of compensation claims following Department of Orthopedic Surgery, Kristiansund Hospital, 6518 Kristiansund, medical treatment [12]. Consequently, there is an in- Norway creased interest in compensation claims related to ortho- Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway pedic surgery [13, 14]. Previous studies have mainly Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Aae et al. BMC Musculoskeletal Disorders (2020) 21:287 Page 2 of 8 reported compensation claims following hip and knee similar conditions enable us to combine data from all arthroplasty and spine disorders [15, 16]. One study has three Scandinavian countries in our analysis. reported malpractice litigation following arthroscopic surgery in general, but to the best of our knowledge, no Participants study has previously reported compensation claims fol- Data from the Danish, Norwegian and Swedish nation- lowing FCDs in the knee specifically [17]. wide registries were obtained from each of the respective The purpose of this study is to evaluate compensation national registries. Patients of both genders and of any claims filed to the Scandinavian registries following sur- age who filed a compensation claim following articular gical treatment of FCDs in the knee joint from 2010 to cartilage surgery of the knee from 2010 to 2015 were 2015 and identify possible areas of improvement. We hy- considered for inclusion. The nationwide databases were pothesized that compensation claims are more frequent searched for a predefined set of diagnosis and surgical after debridement and microfracture (MF) compared to procedures using the International Statistical Classifica- mosaicplasty and autologous chondrocyte implantation tion of Diseases and Related Health Problems 10th Revi- (ACI). sion (ICD-10) and the NOMESCO Classification of Surgical Procedures (NCSP) Version 1.14 [21, 22] (Table 1). The potential patient files were subsequently Methods screened by the corresponding author, identifying pa- Data source tients who had been treated for an isolated cartilage de- In Scandinavia, compensation claims for injuries in con- fects of the knee. The surgical notes were then reviewed nection with medical treatment are handled by nation- before final inclusion (Fig. 1). wide systems. The compensation principle in these The age, gender and nationality of the patients were nations is a no-blame system based on the principle of collected, together with the type of treatment, type of avoidability (i.e. if the injury sustained during treatment complaint and the amount of compensation in granted was avoidable). A no-blame compensation principle sep- cases. The reasons given for granted or rejected claims arates the compensation issue from legal malpractice, were reviewed and systematically analyzed. permitting most indemnity cases in Scandinavia to be settled outside the judicial system. In Norway, the com- Statistics plaints are handled by the Norwegian System of Patient Mean, median and standard deviation were calculated Injury Compensation (NPE) [18]. Patients can appeal for continuous variables. Categorical data were pre- against a decision to the Patient Injury Compensation sented in frequencies and cumulative frequencies. Board, which is under the Ministry of Health. In Groups were compared using the independent t-test or Sweden, the claims are processed by the National Swed- the Chi-square test. A p-value < 0.05 was considered sta- ish Patient Insurance Company, a mutual company tistically significant. The analysis was performed using owned by the counties [19]. In Denmark, the Patient In- IBM SPSS Statistics v25. surance Association handles claims concerning malprac- tice and injuries, as well as injuries caused by medical Results products [20]. We identified 103 compensation claims put forward to In all three systems, compensation is only considered the registries following articular cartilage surgery in the if three conditions are met [18]. Firstly, the injury must knee from 2010 to 2015 (Fig. 1). There was a slight de- have been caused by the examination, diagnosis, treat- crease in claims for compensation the last two years of ment (or lack of treatment) or follow-up of the condi- the study period (Fig. 2). Most claims were put forward tion. The treatment (or lack thereof) must be deemed to the Danish registry (Fig. 3). erroneous or substandard compared to current treat- The average age at the time of surgery was 38.6 years ment guidelines. If the reason for complaint is consid- (11–71). 62 (60.2%) claims were put forward by females ered to be a consequence of the primary injury, and not (Table 2). Claims following debridement (43, 41.7%) and the treatment, compensation is not granted. There is MF (54, 52.4%) was far more common than following one exception to this rule (the reasonability rule). This mosaicplasty (3, 2.9%) and ACI (3, 2.9%). exception permits compensation to be granted after rare Of the 103 claims, 36 were granted (35%). There was and serious complications even if no treatment failure no statistically significant difference in granted claims can be identified. Secondly, the patient must have led a between males and females (15/41 versus 21/62, p = 0.8). substantial financial loss in excess of what would other- 21 of the patients with granted claims were treated with wise be expected. Thirdly, the claim must be put forward debridement (58.3%), 13 with MF (36.1%), 1 with within a reasonable time (currently set to 10 years in mosaicplasty (2.8%) and 1 underwent ACI (2.8%). Infec- Sweden and three years in Denmark and Norway). These tion (22.2%), pain (16.7%), delayed diagnosis or Aae et al. BMC Musculoskeletal Disorders (2020) 21:287 Page 3 of 8 Table 1 Overview of the predefined diagnosis and surgical procedures using the ICD-10 and NCSP codes Diagnosis Surgical procedures M17 Gonarthrosis NGA11 Endoscopic exploration M22.4 Chondromalacia patella NGA12 Open exploration M23.4 Loose body in the knee NGF21 Endoscopic fixation of corpus librum M23.8 Other internal derangements of knee NGF22 Open fixation of corpus librum M23.9 Internal derangement of knee, unspecified NGF31 Endoscopic resection of corpus librum M24.1 Other articular cartilage disorder NGF32 Open resection of corpus librum M24.8 Other specific joint derangements, not elsewhere classified NGF91 Other endoscopic procedure on synovia or articular cartilage M24.9 Joint derangements, unspecified NGF92 Other open procedure on synovia or articular cartilage M25.5 Pain in joint NGG29 Other arthroplasty without prosthesis M25.8 Other specified joint disorders NGG99 Other excision, reconstruction or arthrodesis of knee M25.9 Joint disorder, unspecified NGH41 Endoscopic removal of corpus librum M92.4 Juvenile osteochondrosis, unspecified NGH42 Open removal of corpus librum M92.8 Other specified juvenile osteochondrosis NGH91 Other endoscopic procedure M92.9 Juvenile osteochondrosis, unspecified NGH92 Other open procedure M93.2 Osteochondritis dissecans NGK09 Excision of bony fragment in knee M93.8 Other specified osteochondropaties NGK19 Resection or excision of bone in knee M93.9 Osteochondropathy, unspecified NGK29 Fenestration or drilling of bone in knee S83.3 Tear of articular cartilage of knee, current NGN09 Autotransplantation of bone to knee NGN49 Transplantation of cartilage, periost or fascia to knee NGN99 Other transplantation to knee YNA20 Removal of cartilage for transplantation ZZG00 Cartilage transplantation treatment (13.9%), treatment failure (11.1%) and numb- ness (11.1%) dominated patients’ reasons for complaints (Table 3). Of the patients claiming for compensation due to in- fection, 89% were granted, whereas for pain, only 14% of the claims were granted. 29 patients received compensation related to surgery (such as infection or inadequate surgical technique), whereas 7 patients received compensation unrelated to surgery (such as delayed diagnosis or treatment or fail- ure of medical equipment (Table 4). All 8 patients given compensation due to surgical site infection underwent debridement. One patient who underwent debridement was granted compensation due to an infected peripheral vein catheter. The majority of claims were rejected because good clinical practice was followed or because no causal con- nection was found. Three claims were rejected because there was no financial loss. Complaints from public hospitals were compensated more often (31/89) than complaints from private hospi- tals (5/14) (p = 0.004). A total of €807.086 has been paid in compensation with an average payment of €24.457. In 3 cases the Fig. 1 Flow diagram of patient’s selection included in the study amount of compensation had not yet been settled. The Aae et al. BMC Musculoskeletal Disorders (2020) 21:287 Page 4 of 8 Number of compensation claims during the study period 2010 2011 2012 2013 2014 2015 Granted Denied Fig. 2 Complaints filed to the Scandinavian registries following surgical treatment of focal cartilage defects in the knee joint between 2010 and 2015 median compensation was €5652, with range €209 - the knee joint over a six years period. The main reasons €458.943. The skewed distribution of compensation was for compensations were inadequate surgical technique caused by one patient, who was granted compensation (no further explanation was accessible), hospital- 10 times higher than the second highest compensation. acquired infection, nerve injury and delayed diagnosis or This patient was a 47-year-old female who sustained a treatment. Most claims filed for compensation due to hospital-acquired infection following debridement. This hospital-acquired infection was granted compensation, led to almost 2.5 years of sick-leave, explaining the high all following arthroscopic debridement. Pain was a com- compensation. mon reason for patients’ complaint, but is usually not a valid cause of compensation by itself. Our study also finds that women more often file a claim than men [23]. Discussion There was no mortality recorded or claims due to This study highlights the epidemiology of patient com- wrong-sided surgery. pensation claims following articular cartilage surgery in There was a surprisingly low number of compensation claims identified in Scandinavia in the study period. The true incidence of cartilage procedures is unknown, but the incidence seems to be increasing [24]. Merkely et al. Nationwide distribution of complaints stated that more than 200,000 cartilage procedures were performed annually in America [25], and Engen reported approximately 2500 cartilage procedures are performed annually in Norway [26]. This yields approximately 45, 000 cartilage procedures in Scandinavia during the study period. Based on these numbers, one should expect a higher number of compensation claims. We identified 103 compensation claims over a six-year period, an aver- age of 17 complaints annually. This is substantially lower than the findings of Randsborg et al. who identified 24 compensation claims yearly following anterior cruciate ligament reconstruction in Norway alone [27]. We found more compensation claims in Denmark, despite the fact that Sweden has about twice the popula- tion size. The reason for this is unclear. We believe it re- flects cultural differences, rather than a real difference in the quality of cartilage surgery between the respective countries. In fact, it might indicate that Denmark has a Denmark Norway Sweden better system of detecting patient injury claims. Fig. 3 Nationwide distribution of complaints put forward to the Since the introduction of ACI two decades ago [28], Scandinavian registries following surgical treatment of focal cartilage this procedure has gained popularity both routinely and defects in the knee joint between 2010 and 2015 in clinical trials, as is the case for mosaicplasty [6, 11, Aae et al. BMC Musculoskeletal Disorders (2020) 21:287 Page 5 of 8 Table 2 Age and gender partitioned by declined or rejected claims following surgical treatment of focal cartilage defects in the knee joint Declined, n = 67 (65%) Granted n = 36 (35%) Age, mean (SD, range) 38.5 (10.7, 11–71) 38.8 (12.1, 13–55) 0.93 Females, n (%) 41 (61.1%) 21 (33.9%) 0.77 29]. Nevertheless, compensation claims following Although most complications were related to the sur- mosaicplasty and ACI are almost absent in our material gery, 2 were caused by the anesthesia. This is a reminder covering three countries for six years. Only two cases of that surgery also included risks unrelated to the proced- compensation following mosaicplasty or ACI were ure itself. found. These findings are in line with previous studies Ohrn et al. showed that 23% of all compensation stating that major complications following mosaicplasty claims to the National Swedish Patient Insurance Com- and ACI are very rare [30–33]. Debridement and MF are pany were attributed to orthopedic surgery, whereas low-cost and relatively simple procedures available in Bjerkreim reported that 47% of all compensation claims smaller hospitals and private clinics that cannot offer the filed to the NPE were after orthopedic treatment [35, more advanced cartilage procedures, such as mosaic- 36]. National health oversights in Scandinavia have re- plasty and ACI, which requires highly specialized institu- ported that patients’ complaints have increased in all tions. The total numbers of debridement and MF three countries in recent years [37]. From 2005, there performed annually is much higher than mosaicplasty has been approximately a 10% annual increase in com- and ACI [26]. This explains the large predominance of pensation claims. complaints by debridement and MF. Although patients have become more aware of the Lack of communication and poor patient expectation possibility of applying for compensation, our findings in- management are well-known risk factors for compensa- dicate that complaints following knee cartilage surgery tion claims [34]. It is possible that patients scheduled for are fewer than anticipated. The reason for this may be mosaicplasty or ACI in highly specialized knee units are diverse. Perhaps the surgically treated cartilage patients better prepared and well informed prior to surgery, and are so troubled by their knee that they have low expecta- might receive better follow-up, than patients operated in tions. Or, although unlikely, the surgery is successful for smaller clinics. Furthermore, mosaicplasty and ACI are most of the patients. Another possible reason is the lack often considered salvage procedures when simpler inter- of information from health care professionals regarding ventions have failed. This might alter the patient expec- the opportunity to apply for compensation. tations to these more complex knee surgeries, which The amount of compensation following arthroscopic again affects the threshold for filing a compensation surgery varies greatly between countries. In their study claim. of medical malpractice litigation following knee arthros- copy, Shah et al. found an average settlement of Table 3 Patients’ reasons for complaint in 36 granted claims $848.331 (€733.486) [17]. We found an average compen- following surgical treatment of focal cartilage defects in the sation of €24.457. This is almost exactly the same knee joint amount of compensation granted following anterior cru- Reason for complaints (granted) N = 36 (%) ciate ligament reconstruction in Norway (€24.200) [27]. Infection 8 (22.2%) This indicates that compensation amount is substantially Pain 6 (16.7%) lower in Scandinavia than in the United States. Delayed diagnosis or treatment 5 (13.9%) Table 4 Registries’ reasons for compensation in 36 granted Treatment failure 4 (11.1%) claims following surgical treatment of focal cartilage defects in Numbness 4 (11.1%) the knee joint Spinal headache 2 (5.6%) Reason for granted compensation N = 36 (%) Stiffness 1 (2.8%) Inadequate surgical technique 12 (33.3%) Swelling 1 (2.8%) Hospital-acquired infection 9 (25.0%) Lack of information 1 (2.8%) Nerve injury 5 (13.9%) Infected peripheral vein catheter 1 (2.8%) Delayed diagnosis or treatment 4 (11.1%) Failure of medical equipment 1 (2.8%) Treatment failure 3 (8.3%) Deep vein thrombosis 1 (2.8%) Spinal headache 2 (5.6%) Frozen shoulder 1 (2.8%) Failure of medical equipment 1 (2.8%) Aae et al. BMC Musculoskeletal Disorders (2020) 21:287 Page 6 of 8 The study from the United States by Shah and col- we have tried to reduce this error. The total number of leagues reported medical malpractice litigation following study subjects are relatively low, and may affect the re- arthroscopic surgery [17]. Over 29 years, they reported sults of this study. 162 litigations following knee arthroscopy, yielding less The Scandinavian registries do not comprise all com- than six litigations annually. This is substantially lower plications encountered after cartilage surgery. Some pa- than our findings of 17 compensation claims annually, tients might have suffered a complication that would and they did not specify which treatment was given. have led to compensation, but never filed a complaint to Shah. et al. found that 64% of the claims were rejected, the registries. These factors may contribute to different similar to our findings. They reported musculoskeletal biases to the cases available in the databases. The demo- complaint (listed as chronic pain, stiffness and unsatis- graphics do not include information such as ethnicity, factory result), infection and deep vein thrombosis as the socioeconomic status and insurance status, factors that three main reasons for compensation claims. Different we would like to illuminate. from our finding, Shah reported 19 deaths and 10 cases Patient expectation management is important follow- of wrong-sided surgery, whereas we registered no deaths ing cartilage restoration surgery. Our study is the first or wrong-sided surgery. Our study differs from theirs as national report on compensation claims after cartilage we only report compensation claims following treatment injury and has focused on compensation claims after of FCDs and have excluded other common arthroscopic surgical treatment of focal cartilage defects in the knee. procedures such as ligament reconstruction and menis- Knowledge of compensation claims following conserva- cal procedures. On this basis, our findings supplement tive treatment is lacking and should be highlighted in the results of Shah et al. and add further knowledge in the future in the work on patient safety. Our study has compensation claims following arthroscopic surgery and demonstrated that the claim rate is low following these FCDs in particular. injuries and should be assessed in future research by val- The Scandinavian countries use the no-blame idating patient’s compensation claims by comparing in- principle for practitioners in handling compensation stitutional data with the filed compensation claims. claims, eliminating the fault criterion. This implies that Little is known whether health care professionals fail to no data is shared with the regulatory authorities, and inform patients of the possibility to file a compensation cases are usually handled outside the legal system where claim following a treatment injury. This topic should be the insurance provider recovers the cost of a claim from addressed in future research. the liable party. The no-fault approach system is not unique in Scandinavia, as this is found in Finland, Conclusions France, New Zealand and two American jurisdictions Compensation claims following cartilage surgery in the (Florida and Virginia) [38, 39]. The opposite of a non- knee are rare, and may suggest a lack of patient informa- fault claim is the court-based tort law system, where the tion on compensation claims from health care profes- liable party is responsible for the cost of a claim based sionals. Establishing nationwide cartilage registries can on the fault criterion. This system is among other coun- add further knowledge on this troublesome disease. tries used in the United Kingdom and most American jurisdictions, where patient injury compensation claims are handled by the juridical system [12, 23]. Both these Abbreviations ACI: Autologous chondrocyte implantation; FCDs: Focal cartilage defects; systems have their pros and cons, but one major advan- ICD-10: International Statistical Classification of Diseases and Related Health tage of the no-fault system is that it generates novel pa- Problems 10th Revision; MF: Microfracture; NCSP: NOMESCO Classification of tient safety data for research and learning [40]. Surgical Procedures; NPE: Norwegian System of Patient Injury Compensation The most obvious and major limitation to this study is that we do not know the absolute numbers of each pro- Acknowledgements cedure performed in Scandinavia during the study We thank Pelle Gustafson at the National Swedish Patient Insurance Company, Kim Lyngby Mikkelsen at the Danish Patient Insurance Association period. Therefore, we cannot estimate the risk of com- and Ida Rashida Khan Bukholm at the Norwegian System of Patient Injury pensation for the various surgical techniques. However, Compensation for providing us with data from the nationwide patient our study demonstrates the epidemiology of compensa- insurance systems. tion claims and highlights the need of national cartilage registries. The study population was based on a set of Authors’ contribution predefined diagnosis and surgical procedures. Any kind TFA performed literature search, drafted and edited the article. OBL and LE of mislabeling of these by the orthopedic surgeon may gave critical review of the manuscript. AA launched the hypothesis of the study with study design and gave critical review of the manuscript and cause some patients not to be included, introducing an provided funding. PHR co-drafted and co-edited the article and launched inclusion bias. By using a broad range of diagnosis and the hypothesis and study design. All authors made contributions to design, surgical procedures and not only cartilage specific codes, was involved in the drafting and read and approved the final manuscript. Aae et al. BMC Musculoskeletal Disorders (2020) 21:287 Page 7 of 8 Authors’ information 9. Ozmeric A, Alemdaroglu KB, Aydogan NH. Treatment for cartilage injuries of All authors are members of the Norwegian Cartilage Project, a Norwegian the knee with a new treatment algorithm. World J Orthopedics. 2014;5(5): research organization focusing on improving the treatment of injured 677–84. articular cartilage through five studies. 10. Gomoll AH, Farr J, Gillogly SD, Kercher J, Minas T. Surgical management of articular cartilage defects of the knee. J Bone Joint Surg Am. 2010;92(14): 2470–90. Funding 11. Gracitelli GC, Moraes VY, Franciozi CE, Luzo MV, Belloti JC: Surgical The study was funded by research grants from the Norwegian Research interventions (microfracture, drilling, mosaicplasty, and allograft Council, awarded the Norwegian Cartilage Project (NCP), grant number transplantation) for treating isolated cartilage defects of the knee in adults. The Cochrane database of systematic reviews 2016, 9:Cd010675. 12. Jena AB, Seabury S, Lakdawalla D, Chandra A. Malpractice risk according to Availability of data and materials physician specialty. N Engl J Med. 2011;365(7):629–36. This study brought together existing data obtained upon request and 13. Garrett WE Jr, Swiontkowski MF, Weinstein JN, Callaghan J, Rosier RN, Berry subject to license restrictions from the National Swedish Patient Insurance DJ, Harrast J, Derosa GP. 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Compensation claims after knee cartilage surgery is rare. A registry-based study from Scandinavia from 2010 to 2015

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Abstract

Background: Focal cartilage defects (FCDs) in the knee joint has a high prevalence. A broad range of treatment options exists for symptomatic patients. Knowledge of patient compensation claims following surgical treatment of FCDs is missing. The purpose of this study is to evaluate compensation claims filed to the Scandinavian registries for patient compensation following treatment of FCDs in the knee joint from 2010 to 2015 and identify possible areas of improvement. Methods: A cross-sectional study design was used to obtain all complaints following surgical treatment of FCDs from the Scandinavian registries from 2010 to 2015. Data such as age, gender, type of treatment, type of complaint, reason of verdict and amount of compensation were collected and systematically analyzed. Results: 103 patients filed a compensation claim. 43 had received debridement (41.7%), 54 microfracture (MF) (52.4%), 3 mosaicplasty (2.9%) and 3 autologous chondrocyte implantation (ACI) (2.9%). Of the 103 claims, 36 were granted (35%). 21 following debridement (58.3%), 13 after MF (36.1%), 1 following mosaicplasty (2.8%) and 1 after ACI (2.8%). The most common reason for complaint was infection (22.1%), of which 89% were granted. The average compensation was €24.457 (range €209 –€458.943). Conclusion: Compensation claims following surgical treatment of knee cartilage injuries in Scandinavia are rare. Establishing nationwide cartilage registries can add further knowledge on this troublesome disease. Keywords: Articular cartilage, Microfracture, Autologous chondrocyte implantation, Compensation claim Background osteoarthritis [4, 5]. Surgical treatment relieves symp- Focal cartilage defects (FCDs) in the knee joint is a high toms, but regardless of surgical procedure, the majority prevalence injury that may cause pain and reduced func- of patients do not achieve normal knee function [6–8]. tion, with the risk of early onset osteoarthritis [1–3]. No method or treatment has proved to be superior to Various surgical treatment options are available. The any other, and there is currently no gold standard or goal of operative treatment is to restore the articular car- consensus on what constitutes the best treatment for tilage and reduce symptoms and minimizing the risk of FCDs of the knee [9–11]. Orthopedic surgery is one of the medical specialties * Correspondence: tommy.aae@gmail.com with the highest rate of compensation claims following Department of Orthopedic Surgery, Kristiansund Hospital, 6518 Kristiansund, medical treatment [12]. Consequently, there is an in- Norway creased interest in compensation claims related to ortho- Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway pedic surgery [13, 14]. Previous studies have mainly Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Aae et al. BMC Musculoskeletal Disorders (2020) 21:287 Page 2 of 8 reported compensation claims following hip and knee similar conditions enable us to combine data from all arthroplasty and spine disorders [15, 16]. One study has three Scandinavian countries in our analysis. reported malpractice litigation following arthroscopic surgery in general, but to the best of our knowledge, no Participants study has previously reported compensation claims fol- Data from the Danish, Norwegian and Swedish nation- lowing FCDs in the knee specifically [17]. wide registries were obtained from each of the respective The purpose of this study is to evaluate compensation national registries. Patients of both genders and of any claims filed to the Scandinavian registries following sur- age who filed a compensation claim following articular gical treatment of FCDs in the knee joint from 2010 to cartilage surgery of the knee from 2010 to 2015 were 2015 and identify possible areas of improvement. We hy- considered for inclusion. The nationwide databases were pothesized that compensation claims are more frequent searched for a predefined set of diagnosis and surgical after debridement and microfracture (MF) compared to procedures using the International Statistical Classifica- mosaicplasty and autologous chondrocyte implantation tion of Diseases and Related Health Problems 10th Revi- (ACI). sion (ICD-10) and the NOMESCO Classification of Surgical Procedures (NCSP) Version 1.14 [21, 22] (Table 1). The potential patient files were subsequently Methods screened by the corresponding author, identifying pa- Data source tients who had been treated for an isolated cartilage de- In Scandinavia, compensation claims for injuries in con- fects of the knee. The surgical notes were then reviewed nection with medical treatment are handled by nation- before final inclusion (Fig. 1). wide systems. The compensation principle in these The age, gender and nationality of the patients were nations is a no-blame system based on the principle of collected, together with the type of treatment, type of avoidability (i.e. if the injury sustained during treatment complaint and the amount of compensation in granted was avoidable). A no-blame compensation principle sep- cases. The reasons given for granted or rejected claims arates the compensation issue from legal malpractice, were reviewed and systematically analyzed. permitting most indemnity cases in Scandinavia to be settled outside the judicial system. In Norway, the com- Statistics plaints are handled by the Norwegian System of Patient Mean, median and standard deviation were calculated Injury Compensation (NPE) [18]. Patients can appeal for continuous variables. Categorical data were pre- against a decision to the Patient Injury Compensation sented in frequencies and cumulative frequencies. Board, which is under the Ministry of Health. In Groups were compared using the independent t-test or Sweden, the claims are processed by the National Swed- the Chi-square test. A p-value < 0.05 was considered sta- ish Patient Insurance Company, a mutual company tistically significant. The analysis was performed using owned by the counties [19]. In Denmark, the Patient In- IBM SPSS Statistics v25. surance Association handles claims concerning malprac- tice and injuries, as well as injuries caused by medical Results products [20]. We identified 103 compensation claims put forward to In all three systems, compensation is only considered the registries following articular cartilage surgery in the if three conditions are met [18]. Firstly, the injury must knee from 2010 to 2015 (Fig. 1). There was a slight de- have been caused by the examination, diagnosis, treat- crease in claims for compensation the last two years of ment (or lack of treatment) or follow-up of the condi- the study period (Fig. 2). Most claims were put forward tion. The treatment (or lack thereof) must be deemed to the Danish registry (Fig. 3). erroneous or substandard compared to current treat- The average age at the time of surgery was 38.6 years ment guidelines. If the reason for complaint is consid- (11–71). 62 (60.2%) claims were put forward by females ered to be a consequence of the primary injury, and not (Table 2). Claims following debridement (43, 41.7%) and the treatment, compensation is not granted. There is MF (54, 52.4%) was far more common than following one exception to this rule (the reasonability rule). This mosaicplasty (3, 2.9%) and ACI (3, 2.9%). exception permits compensation to be granted after rare Of the 103 claims, 36 were granted (35%). There was and serious complications even if no treatment failure no statistically significant difference in granted claims can be identified. Secondly, the patient must have led a between males and females (15/41 versus 21/62, p = 0.8). substantial financial loss in excess of what would other- 21 of the patients with granted claims were treated with wise be expected. Thirdly, the claim must be put forward debridement (58.3%), 13 with MF (36.1%), 1 with within a reasonable time (currently set to 10 years in mosaicplasty (2.8%) and 1 underwent ACI (2.8%). Infec- Sweden and three years in Denmark and Norway). These tion (22.2%), pain (16.7%), delayed diagnosis or Aae et al. BMC Musculoskeletal Disorders (2020) 21:287 Page 3 of 8 Table 1 Overview of the predefined diagnosis and surgical procedures using the ICD-10 and NCSP codes Diagnosis Surgical procedures M17 Gonarthrosis NGA11 Endoscopic exploration M22.4 Chondromalacia patella NGA12 Open exploration M23.4 Loose body in the knee NGF21 Endoscopic fixation of corpus librum M23.8 Other internal derangements of knee NGF22 Open fixation of corpus librum M23.9 Internal derangement of knee, unspecified NGF31 Endoscopic resection of corpus librum M24.1 Other articular cartilage disorder NGF32 Open resection of corpus librum M24.8 Other specific joint derangements, not elsewhere classified NGF91 Other endoscopic procedure on synovia or articular cartilage M24.9 Joint derangements, unspecified NGF92 Other open procedure on synovia or articular cartilage M25.5 Pain in joint NGG29 Other arthroplasty without prosthesis M25.8 Other specified joint disorders NGG99 Other excision, reconstruction or arthrodesis of knee M25.9 Joint disorder, unspecified NGH41 Endoscopic removal of corpus librum M92.4 Juvenile osteochondrosis, unspecified NGH42 Open removal of corpus librum M92.8 Other specified juvenile osteochondrosis NGH91 Other endoscopic procedure M92.9 Juvenile osteochondrosis, unspecified NGH92 Other open procedure M93.2 Osteochondritis dissecans NGK09 Excision of bony fragment in knee M93.8 Other specified osteochondropaties NGK19 Resection or excision of bone in knee M93.9 Osteochondropathy, unspecified NGK29 Fenestration or drilling of bone in knee S83.3 Tear of articular cartilage of knee, current NGN09 Autotransplantation of bone to knee NGN49 Transplantation of cartilage, periost or fascia to knee NGN99 Other transplantation to knee YNA20 Removal of cartilage for transplantation ZZG00 Cartilage transplantation treatment (13.9%), treatment failure (11.1%) and numb- ness (11.1%) dominated patients’ reasons for complaints (Table 3). Of the patients claiming for compensation due to in- fection, 89% were granted, whereas for pain, only 14% of the claims were granted. 29 patients received compensation related to surgery (such as infection or inadequate surgical technique), whereas 7 patients received compensation unrelated to surgery (such as delayed diagnosis or treatment or fail- ure of medical equipment (Table 4). All 8 patients given compensation due to surgical site infection underwent debridement. One patient who underwent debridement was granted compensation due to an infected peripheral vein catheter. The majority of claims were rejected because good clinical practice was followed or because no causal con- nection was found. Three claims were rejected because there was no financial loss. Complaints from public hospitals were compensated more often (31/89) than complaints from private hospi- tals (5/14) (p = 0.004). A total of €807.086 has been paid in compensation with an average payment of €24.457. In 3 cases the Fig. 1 Flow diagram of patient’s selection included in the study amount of compensation had not yet been settled. The Aae et al. BMC Musculoskeletal Disorders (2020) 21:287 Page 4 of 8 Number of compensation claims during the study period 2010 2011 2012 2013 2014 2015 Granted Denied Fig. 2 Complaints filed to the Scandinavian registries following surgical treatment of focal cartilage defects in the knee joint between 2010 and 2015 median compensation was €5652, with range €209 - the knee joint over a six years period. The main reasons €458.943. The skewed distribution of compensation was for compensations were inadequate surgical technique caused by one patient, who was granted compensation (no further explanation was accessible), hospital- 10 times higher than the second highest compensation. acquired infection, nerve injury and delayed diagnosis or This patient was a 47-year-old female who sustained a treatment. Most claims filed for compensation due to hospital-acquired infection following debridement. This hospital-acquired infection was granted compensation, led to almost 2.5 years of sick-leave, explaining the high all following arthroscopic debridement. Pain was a com- compensation. mon reason for patients’ complaint, but is usually not a valid cause of compensation by itself. Our study also finds that women more often file a claim than men [23]. Discussion There was no mortality recorded or claims due to This study highlights the epidemiology of patient com- wrong-sided surgery. pensation claims following articular cartilage surgery in There was a surprisingly low number of compensation claims identified in Scandinavia in the study period. The true incidence of cartilage procedures is unknown, but the incidence seems to be increasing [24]. Merkely et al. Nationwide distribution of complaints stated that more than 200,000 cartilage procedures were performed annually in America [25], and Engen reported approximately 2500 cartilage procedures are performed annually in Norway [26]. This yields approximately 45, 000 cartilage procedures in Scandinavia during the study period. Based on these numbers, one should expect a higher number of compensation claims. We identified 103 compensation claims over a six-year period, an aver- age of 17 complaints annually. This is substantially lower than the findings of Randsborg et al. who identified 24 compensation claims yearly following anterior cruciate ligament reconstruction in Norway alone [27]. We found more compensation claims in Denmark, despite the fact that Sweden has about twice the popula- tion size. The reason for this is unclear. We believe it re- flects cultural differences, rather than a real difference in the quality of cartilage surgery between the respective countries. In fact, it might indicate that Denmark has a Denmark Norway Sweden better system of detecting patient injury claims. Fig. 3 Nationwide distribution of complaints put forward to the Since the introduction of ACI two decades ago [28], Scandinavian registries following surgical treatment of focal cartilage this procedure has gained popularity both routinely and defects in the knee joint between 2010 and 2015 in clinical trials, as is the case for mosaicplasty [6, 11, Aae et al. BMC Musculoskeletal Disorders (2020) 21:287 Page 5 of 8 Table 2 Age and gender partitioned by declined or rejected claims following surgical treatment of focal cartilage defects in the knee joint Declined, n = 67 (65%) Granted n = 36 (35%) Age, mean (SD, range) 38.5 (10.7, 11–71) 38.8 (12.1, 13–55) 0.93 Females, n (%) 41 (61.1%) 21 (33.9%) 0.77 29]. Nevertheless, compensation claims following Although most complications were related to the sur- mosaicplasty and ACI are almost absent in our material gery, 2 were caused by the anesthesia. This is a reminder covering three countries for six years. Only two cases of that surgery also included risks unrelated to the proced- compensation following mosaicplasty or ACI were ure itself. found. These findings are in line with previous studies Ohrn et al. showed that 23% of all compensation stating that major complications following mosaicplasty claims to the National Swedish Patient Insurance Com- and ACI are very rare [30–33]. Debridement and MF are pany were attributed to orthopedic surgery, whereas low-cost and relatively simple procedures available in Bjerkreim reported that 47% of all compensation claims smaller hospitals and private clinics that cannot offer the filed to the NPE were after orthopedic treatment [35, more advanced cartilage procedures, such as mosaic- 36]. National health oversights in Scandinavia have re- plasty and ACI, which requires highly specialized institu- ported that patients’ complaints have increased in all tions. The total numbers of debridement and MF three countries in recent years [37]. From 2005, there performed annually is much higher than mosaicplasty has been approximately a 10% annual increase in com- and ACI [26]. This explains the large predominance of pensation claims. complaints by debridement and MF. Although patients have become more aware of the Lack of communication and poor patient expectation possibility of applying for compensation, our findings in- management are well-known risk factors for compensa- dicate that complaints following knee cartilage surgery tion claims [34]. It is possible that patients scheduled for are fewer than anticipated. The reason for this may be mosaicplasty or ACI in highly specialized knee units are diverse. Perhaps the surgically treated cartilage patients better prepared and well informed prior to surgery, and are so troubled by their knee that they have low expecta- might receive better follow-up, than patients operated in tions. Or, although unlikely, the surgery is successful for smaller clinics. Furthermore, mosaicplasty and ACI are most of the patients. Another possible reason is the lack often considered salvage procedures when simpler inter- of information from health care professionals regarding ventions have failed. This might alter the patient expec- the opportunity to apply for compensation. tations to these more complex knee surgeries, which The amount of compensation following arthroscopic again affects the threshold for filing a compensation surgery varies greatly between countries. In their study claim. of medical malpractice litigation following knee arthros- copy, Shah et al. found an average settlement of Table 3 Patients’ reasons for complaint in 36 granted claims $848.331 (€733.486) [17]. We found an average compen- following surgical treatment of focal cartilage defects in the sation of €24.457. This is almost exactly the same knee joint amount of compensation granted following anterior cru- Reason for complaints (granted) N = 36 (%) ciate ligament reconstruction in Norway (€24.200) [27]. Infection 8 (22.2%) This indicates that compensation amount is substantially Pain 6 (16.7%) lower in Scandinavia than in the United States. Delayed diagnosis or treatment 5 (13.9%) Table 4 Registries’ reasons for compensation in 36 granted Treatment failure 4 (11.1%) claims following surgical treatment of focal cartilage defects in Numbness 4 (11.1%) the knee joint Spinal headache 2 (5.6%) Reason for granted compensation N = 36 (%) Stiffness 1 (2.8%) Inadequate surgical technique 12 (33.3%) Swelling 1 (2.8%) Hospital-acquired infection 9 (25.0%) Lack of information 1 (2.8%) Nerve injury 5 (13.9%) Infected peripheral vein catheter 1 (2.8%) Delayed diagnosis or treatment 4 (11.1%) Failure of medical equipment 1 (2.8%) Treatment failure 3 (8.3%) Deep vein thrombosis 1 (2.8%) Spinal headache 2 (5.6%) Frozen shoulder 1 (2.8%) Failure of medical equipment 1 (2.8%) Aae et al. BMC Musculoskeletal Disorders (2020) 21:287 Page 6 of 8 The study from the United States by Shah and col- we have tried to reduce this error. The total number of leagues reported medical malpractice litigation following study subjects are relatively low, and may affect the re- arthroscopic surgery [17]. Over 29 years, they reported sults of this study. 162 litigations following knee arthroscopy, yielding less The Scandinavian registries do not comprise all com- than six litigations annually. This is substantially lower plications encountered after cartilage surgery. Some pa- than our findings of 17 compensation claims annually, tients might have suffered a complication that would and they did not specify which treatment was given. have led to compensation, but never filed a complaint to Shah. et al. found that 64% of the claims were rejected, the registries. These factors may contribute to different similar to our findings. They reported musculoskeletal biases to the cases available in the databases. The demo- complaint (listed as chronic pain, stiffness and unsatis- graphics do not include information such as ethnicity, factory result), infection and deep vein thrombosis as the socioeconomic status and insurance status, factors that three main reasons for compensation claims. Different we would like to illuminate. from our finding, Shah reported 19 deaths and 10 cases Patient expectation management is important follow- of wrong-sided surgery, whereas we registered no deaths ing cartilage restoration surgery. Our study is the first or wrong-sided surgery. Our study differs from theirs as national report on compensation claims after cartilage we only report compensation claims following treatment injury and has focused on compensation claims after of FCDs and have excluded other common arthroscopic surgical treatment of focal cartilage defects in the knee. procedures such as ligament reconstruction and menis- Knowledge of compensation claims following conserva- cal procedures. On this basis, our findings supplement tive treatment is lacking and should be highlighted in the results of Shah et al. and add further knowledge in the future in the work on patient safety. Our study has compensation claims following arthroscopic surgery and demonstrated that the claim rate is low following these FCDs in particular. injuries and should be assessed in future research by val- The Scandinavian countries use the no-blame idating patient’s compensation claims by comparing in- principle for practitioners in handling compensation stitutional data with the filed compensation claims. claims, eliminating the fault criterion. This implies that Little is known whether health care professionals fail to no data is shared with the regulatory authorities, and inform patients of the possibility to file a compensation cases are usually handled outside the legal system where claim following a treatment injury. This topic should be the insurance provider recovers the cost of a claim from addressed in future research. the liable party. The no-fault approach system is not unique in Scandinavia, as this is found in Finland, Conclusions France, New Zealand and two American jurisdictions Compensation claims following cartilage surgery in the (Florida and Virginia) [38, 39]. The opposite of a non- knee are rare, and may suggest a lack of patient informa- fault claim is the court-based tort law system, where the tion on compensation claims from health care profes- liable party is responsible for the cost of a claim based sionals. Establishing nationwide cartilage registries can on the fault criterion. This system is among other coun- add further knowledge on this troublesome disease. tries used in the United Kingdom and most American jurisdictions, where patient injury compensation claims are handled by the juridical system [12, 23]. Both these Abbreviations ACI: Autologous chondrocyte implantation; FCDs: Focal cartilage defects; systems have their pros and cons, but one major advan- ICD-10: International Statistical Classification of Diseases and Related Health tage of the no-fault system is that it generates novel pa- Problems 10th Revision; MF: Microfracture; NCSP: NOMESCO Classification of tient safety data for research and learning [40]. Surgical Procedures; NPE: Norwegian System of Patient Injury Compensation The most obvious and major limitation to this study is that we do not know the absolute numbers of each pro- Acknowledgements cedure performed in Scandinavia during the study We thank Pelle Gustafson at the National Swedish Patient Insurance Company, Kim Lyngby Mikkelsen at the Danish Patient Insurance Association period. Therefore, we cannot estimate the risk of com- and Ida Rashida Khan Bukholm at the Norwegian System of Patient Injury pensation for the various surgical techniques. However, Compensation for providing us with data from the nationwide patient our study demonstrates the epidemiology of compensa- insurance systems. tion claims and highlights the need of national cartilage registries. The study population was based on a set of Authors’ contribution predefined diagnosis and surgical procedures. Any kind TFA performed literature search, drafted and edited the article. OBL and LE of mislabeling of these by the orthopedic surgeon may gave critical review of the manuscript. AA launched the hypothesis of the study with study design and gave critical review of the manuscript and cause some patients not to be included, introducing an provided funding. PHR co-drafted and co-edited the article and launched inclusion bias. By using a broad range of diagnosis and the hypothesis and study design. All authors made contributions to design, surgical procedures and not only cartilage specific codes, was involved in the drafting and read and approved the final manuscript. Aae et al. BMC Musculoskeletal Disorders (2020) 21:287 Page 7 of 8 Authors’ information 9. Ozmeric A, Alemdaroglu KB, Aydogan NH. Treatment for cartilage injuries of All authors are members of the Norwegian Cartilage Project, a Norwegian the knee with a new treatment algorithm. World J Orthopedics. 2014;5(5): research organization focusing on improving the treatment of injured 677–84. articular cartilage through five studies. 10. Gomoll AH, Farr J, Gillogly SD, Kercher J, Minas T. Surgical management of articular cartilage defects of the knee. J Bone Joint Surg Am. 2010;92(14): 2470–90. Funding 11. Gracitelli GC, Moraes VY, Franciozi CE, Luzo MV, Belloti JC: Surgical The study was funded by research grants from the Norwegian Research interventions (microfracture, drilling, mosaicplasty, and allograft Council, awarded the Norwegian Cartilage Project (NCP), grant number transplantation) for treating isolated cartilage defects of the knee in adults. The Cochrane database of systematic reviews 2016, 9:Cd010675. 12. Jena AB, Seabury S, Lakdawalla D, Chandra A. Malpractice risk according to Availability of data and materials physician specialty. N Engl J Med. 2011;365(7):629–36. This study brought together existing data obtained upon request and 13. Garrett WE Jr, Swiontkowski MF, Weinstein JN, Callaghan J, Rosier RN, Berry subject to license restrictions from the National Swedish Patient Insurance DJ, Harrast J, Derosa GP. American Board of Orthopaedic Surgery Practice of Company, the Danish Patient Insurance Association and the Norwegian the Orthopaedic surgeon: part-II, certification examination case mix. J Bone System of Patient Injury Compensation. The authors declare that the data Joint Surg Am. 2006;88(3):660–7. supporting the findings of this study are available within the article. 14. Mello MM, Studdert DM, Kachalia A. The medical liability climate and prospects for reform. Jama. 2014;312(20):2146–55. Ethics approval and consent to participate 15. Bokshan SL, Ruttiman RJ, DePasse JM, Eltorai AEM, Rubin LE, Palumbo MA, The study was conducted according to the World Association Declaration of Daniels AH: Reported Litigation Associated With Primary Hip and Knee Helsinki and was approved by the data protection officer of Helse Møre and Arthroplasty. The Journal of arthroplasty 2017, 32(12):3573–3577.e3571. Romsdal HF, Kristiansund Hospital, Norway (study no 2018/1357–11). As all 16. 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Published: May 8, 2020

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