Prevalence of malpractice claims after arthroscopic shoulder surgery: analysis of 69,097 procedures from a national registry in Norway.

BACKGROUND: Systematic analysis of compensation claims following patient injuries is helpful in improving patient safety. The objective of the current study was to assess compensation claims after arthroscopic treatment of rotator cuff ruptures, impingement, and acromioclavicular joint osteoarthritis reported to the Norwegian System of Patient Injury Compensation and evaluate if there was regional variation on the risk of patient injuries leading to an accepted compensation claim. METHODS: Data from the Norwegian System of Patient Injury Compensation and the Norwegian Patient Registry (NPR) from 2008 to 2018 were collected. Demographics (age and sex) and type of claim and reasons for accepted claims were obtained from the Norwegian System of Patient Injury Compensation, while the number of arthroscopic procedures was collected from NPR. The treating institutions were grouped on geography according to Norway's four regional Health Trusts and private institutions and the effect of geography on the probability of an accepted claim was estimated. RESULTS: NPR registered 69,097 shoulder arthroscopies during the study period, of which 216 (0.3%) compensation claims were filed for patient injury. A total of 38% of the claims were accepted, representing 0.1% of the arthroscopic procedures. Infection (37.8%) was the most common reason for accepted claim, followed by no surgical indication (15.9%) and wrong surgical technique (12.2%). We found a statistically significantly increased odds ratio for a claim being accepted in both the smallest and largest regional Health Trusts compared to the other regional Health Trusts and private institutions. CONCLUSIONS: Compensation claims due to patient injury following shoulder arthroscopy are rare (0.3% of patients file a claim, of which a third is accepted (0.1% of all shoulder arthroscopy patients)). The most common reason for accepted claim was infection followed by lack of indication.

Compensation Claims After Hip Fracture Surgery in Norway 2008-2018.

Background: Surgical complications contribute to the significant mortality following hip fractures in the elderly. The purpose of this study was to increase our knowledge of surgical complications by evaluating compensation claims following hip fracture surgery in Norway. Further, we investigated whether the size and location of performing institutions would influence surgical complications. Methods: We collected data from the Norwegian System of Patient Injury Compensation (NPE) and the Norwegian Hip Fracture Register (NHFR) from 2008 to 2018. We classified institutions into 4 categories based on annual procedure volume and geographical location. Results: 90,601 hip fractures were registered in NHFR. NPE received 616 (.7%) claims. Of these, 221 (36%) were accepted, which accounts for .2% of all hip fractures. Men had nearly a doubled risk of ending with a compensation claim compared to women (OR: 1.8, CI, 1.4-2.4, P < .001). Hospital-acquired infection was the most frequent reason for accepted claims (27%). However, claims were rejected if patients had underlying conditions predisposing to infection. Institutions treating fewer than 152 hip fractures (first quartile) annually, had a statistically significant increased risk (OR: 1.9, CI, 1.3-2.8, P = .005) for accepted claims compared to higher volume facilities. Discussion: The fewer registered claims in our study could be due to the relatively high early mortality and frailty in this patient group, which may decrease the likelihood of filing a complaint. Men could have undetected underlying predisposing conditions that lead to increased risk of complications. Hospital-acquired infection may be the most significant complication following hip fracture surgery in Norway. Lastly, the number of procedures performed annually in an institution influences compensation claims. Conclusions: Our findings indicate that hospital acquired infections need greater focus following hip fracture surgery, especially in men. Lower volume hospitals may be a risk factor.

Compensation claims after hip arthroplasty surgery in Norway 2008-2018.

Background and purpose - Orthopedic surgery is one of the specialties with most compensation claims, therefore we assessed the most common reasons for complaints following total hip arthroplasty (THA) reported to the Norwegian System of Patient Injury Compensation (NPE) and viewed these complaints in light of the data from the Norwegian Arthroplasty Register (NAR).Patients and methods - We collected data from NPE and NAR for the study period (2008-2018), including age, sex, and type of complaint, and reason for accepted claims from NPE, and the number of arthroplasty surgeries from NAR. The institutions were grouped by quartiles into quarters according to annual procedure volume, and the effect of hospital procedure volume on the risk for accepted claim was estimated.Results - 70,327 THAs were reported to NAR. NPE handled 1,350 claims, corresponding to 1.9% of all reported THAs. 595 (44%) claims were accepted, representing 0.8% of all THAs. Hospital-acquired infection was the most common reason for accepted claims (34%), followed by wrong implant position in 11% of patients. Low annual volume institutions (less than 93 THAs per year) had a statistically significant 1.6 times higher proportion of accepted claims compared with higher volume institutions.Interpretation - The 0.8% risk of accepted claims following THAs is 1.6 times higher for patients treated in low-volume institutions, which should consider increasing the volume of THAs or referring these patients to higher volume institutions.

Compensation claims after knee arthroplasty surgery in Norway 2008-2018.

Background and purpose - Orthopedic surgery is one of the specialties with most compensation claims. We assessed the claims following knee arthroplasty surgery reported to the Norwegian System of Patient Injury Compensation (NPE) in light of institutional procedure volume.Patients and methods - We collected data from NPE and the Norwegian Arthroplasty Register (NAR) for the study period (2008-2018). Age, sex, type of claim, and reason for compensation were collected from NPE, while the number of arthroplasty surgeries was collected from NAR. The treating hospitals were grouped by quartiles according to annual procedure volume. The effect of hospital volume on the likelihood of an accepted claim was estimated.Results - NAR received 64,241 reports of arthroplasty procedures, of which 572 (0.9%) patients filed a claim for treatment injury. 55% of the claims were accepted, representing 0.5% of all knee arthroplasties. The most common reason for accepted claim was a hospital-acquired infection, in 28% of the patients, followed by misplaced implant (26%) and aseptic loosening (13%). The hospitals with the lowest annual volume (57 or fewer arthroplasties per year, first quarter) had a statistically significantly larger fraction of granted claims per procedures compared with other institutions.Interpretation - The overall risk of ending up with compensation due to treatment error following knee arthroplasty was 0.5%. The risk of accepted claim was greater for patients operated in the lowest volume hospitals.

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

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.

Evaluating plasma extracellular vesicle microRNAs as possible biomarkers for osteoarthritis.

Objective: MicroRNAs (miRNAs) are being launched as biomarkers for various diseases, but a robust biomarker for articular cartilage pathology has yet to be discovered. Here we evaluate plasma extracellular vesicle (EV) miRNAs as possible biomarkers for osteoarthritis (OA). Method: We compared miRNA levels found in plasma EVs from patients with OA with controls without OA using next generation sequencing (NGS) technique. The patient and control pairs were matched for age, gender and body mass index. Results: 23 pairs of patients and controls were included. Patients with OA differed significantly from controls in both clinical and radiological assessment of OA. We identified 177 canonical miRNAs in plasma EVs, but found no difference in miRNA levels between the two groups. Interestingly, the concentration of each miRNA in plasma EVs showed minimal difference between the participants, suggesting that the release of miRNAs in EVs from cells within the various organs is a tightly controlled process. Conclusion: This is the first study using NGS in search of a miRNA biomarker in plasma EVs in OA. The levels of each plasma EVs miRNA were surprisingly similar for all participants. No plasma EVs miRNA can be used as a biomarker for OA.

Microfracture is more cost-effective than autologous chondrocyte implantation: a review of level 1 and level 2 studies with 5 year follow-up.

PURPOSE: Focal cartilage defects in the knee may have devastating effect on the knee joint, where two of the main surgical treatment options are microfracture and autologous chondrocyte implantation. Comparative studies have failed to establish which method yields the best clinical results. A cost-effectiveness analysis of microfracture and autologous chondrocyte implantation would contribute to the clinical decision process. METHODS: A PubMed search identifying level I and level II studies with 5 year follow-up was performed. With the data from these studies, decision trees with associated service provision and costs connected to the two different techniques were designed. In addition to hospital costs, we included costs connected to physiotherapy following surgery. To paint a broader cost picture, we also included indirect costs to the society due to productivity loss caused by work absence. RESULTS: Four high-quality studies, with a follow-up of 5 years, met the inclusion criteria. A total of 319 patients were included, 170 undergoing microfracture and 149 autologous chondrocyte implantation. The re-operation rate was 23 (13.5%) following microfracture, and 18 (12.1%) for autologous chondrocyte implantation. Both groups achieved substantially better clinical scores at 5 years compared to baseline. Microfracture was more cost-effective when comparing all clinical scores. CONCLUSION: Microfracture is associated with both lower costs and lower cost per point increase in patient reported outcome measures. There is a need of well-designed, high-quality randomized controlled trials before reliable conclusions regarding cost-effectiveness in the long run is possible. LEVEL OF EVIDENCE: III.

Norwegican Cartilage Project - a study protocol for a double-blinded randomized controlled trial comparing arthroscopic microfracture with arthroscopic debridement in focal cartilage defects in the knee.

BACKGROUND: Focal lesions to the articular cartilage in the knee might have demolishing consequences to the knee. There exists a wide range of possible surgical procedures targeting these injuries, however no significant differences have been found between these procedures. This may support that the improvement is a result of rehabilitation, and not the surgery itself. Arthroscopic microfracture (MF) treatment has gained popularity, and has become the treatment of choice in patients with knee cartilage defects globally. In this study we want to increase knowledge, both clinical and economic, about arthroscopic microfracture (AF) compared to arthroscopic debridement (AD) and physical rehabilitation both in the short run, and in the long run. METHODS/DESIGN: To compare arthroscopic microfracture with arthroscopic debridement and physiotherapy for the treatment of focal cartilage lesions in the knee, a long-term, double-blinded, randomized controlled multicenter trial will be conducted. A total of 114 men and non-pregnant women with a symptomatic focal full thickness cartilage lesion in the knee less than 2 cm2 will be included in the study. The two treatment allocations will receive identical rehabilitation, which is made up of 3 phases: accommodation, rehabilitation and return to activity. Follow up is 24 months, where all will be invited to participate in late follow ups after 5 and 10 years. The Knee Injury and Osteoarthritis Outcome Score (KOOS) knee-related quality of life (QoL) subscore is the primary endpoint. Clinical parameters, questionnaires and radiologic modalities (Magnetic Resonance Imaging (MRI) and x-ray) will be used as secondary endpoints. DISCUSSION: This is an ongoing multicenter study with a high level of evidence to compare arthroscopic microfracture with arthroscopic debridement and physiotherapy for the treatment of isolated symptomatic full thickness cartilage lesions in the knee joint. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT02637505 (December 15, 2015).

Focal cartilage defects in the knee - a randomized controlled trial comparing autologous chondrocyte implantation with arthroscopic debridement.

BACKGROUND: Focal cartilage injuries in the knee might have devastating effect due to the predisposition of early onset osteoarthritis. Various surgical treatment options are available, however no statistically significant differences have been found between the different surgical treatments. This supports the suggestion that the improvement might be a result of the post-operative rehabilitation rather than the surgery itself. Autologous chondrocyte implantation (ACI) has become a recognized treatment option for larger cartilage lesions in the knee. Although ACI has been compared to other surgical treatment such as microfracture and mosaicplasty, it has never been directly compared to simple arthroscopic debridement and rehabilitation alone. In this study we want to increase clinical and economic knowledge about autologous chondrocyte implantation compared to arthroscopic debridement and physical rehabilitation in the short and long run. METHODS/DESIGN: We will conduct a randomized controlled trial to compare ACI with simple arthroscopic debridement (AD) and physiotherapy for the treatment of cartilage lesions in the knee. The study will include a total of 82 patients, both men and non-pregnant women, with a full thickness cartilage defect in the weight bearing area of the femoral condyles or trochlea larger than 2 cm2. The lesion must be symptomatic, with a Lysholm score less than 75. The two treatment groups will receive identical rehabilitation protocol according to a modification of Wondrasch et al., which is an active rehabilitation and education program divided into 3 phases: accommodation, rehabilitation and return to activity. The patients will be followed for 24 months, with additional late follow-ups at 5 and 10 years to monitor the potential onset of osteoarthtitis. The primary outcome measure will be the difference in the KOOS knee-related quality of life (QoL) subscore in the ACI group compared to the AD group at 2 years. A combination of self-explanatory questionnaires, clinical parameters, clinical hop tests and radiographs and Magnetic Resonance Imaging (MRI) will be used as secondary endpoints. DISCUSSION: This is the first study with a high level of evidence to compare ACI with simple debridement and physiotherapy for the treatment of isolated symptomatic full thickness lesions of the knee. TRIAL REGISTRATION: ClinicalTrial NCT02636881 (21 December 2015).