Needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren's contractures of the fingers (Hand-2): study protocol for a randomised controlled trial.

BACKGROUND: Dupuytren's contractures (DC) are fibrous cords under the skin of the hand that cause one or more fingers to curl gradually and irreversibly towards the palm. These contractures are usually painless but can cause a loss of hand function. Two treatments for Dupuytren's contractures are widely used within the National Health Service (NHS) in the UK: removal of the contractures via surgery (limited fasciectomy) and division of the contractures via a needle inserted through the skin (needle fasciotomy). This study aims to establish the clinical and cost-effectiveness of needle fasciotomy (NF) versus limited fasciectomy (LF) for the treatment of DC in the NHS, in terms of patient-reported hand function and resource utilisation. METHODS/DESIGN: Hand-2 is a national multi-centre, two-arm, parallel-group randomised, non-inferiority trial. Patients will be eligible to join the trial if they are aged 18 years or older, have at least one previously untreated finger with a well-defined Dupuytren's contracture of 30° or greater that causes functional problems and is suitable for treatment with either LF or NF. Patients with a contracture of the distal interphalangeal joint only are ineligible. Eligible consenting patients will be randomised 1:1 to receive either NF or LF and will be followed up for 24 months post-treatment. A QuinteT Recruitment Intervention will be used to optimise recruitment. The primary outcome measure is the participant-reported assessment of hand function, assessed by the Hand Health Profile of the Patient Evaluation Measure (PEM) questionnaire at 12 months post-treatment. Secondary outcomes include other patient-reported measures, loss of finger movement, and cost-effectiveness, reported over the 24-month post-treatment. Embedded qualitative research will explore patient experiences and acceptability of treatment at 2 years post-surgery. DISCUSSION: This study will determine whether treatment with needle fasciotomy is non-inferior to limited fasciectomy in terms of patient-reported hand function at 12 months post-treatment. TRIAL REGISTRATION: International Standard Registered Clinical/soCial sTudy ISRCTN12525655. Registered on 18th September 2020.

Dupuytren's Contracture Recurrence and Treatment Following Collagenase Clostridium Histolyticum Injection: A Longitudinal Assessment in a Veteran Population.

INTRODUCTION: Dupuytren's contracture is a connective tissue disease characterized by an abnormal proliferation of collagen in the palm and fingers, which leads to a decline in hand function because of progressive joint flexion. In addition to surgical and percutaneous interventions, collagenase clostridium histolyticum (CCH, trade name Xiaflex) is an intralesional enzymatic treatment for adults with palpable cords. The objectives of this study are to evaluate factors predictive of recurrence following treatment with CCH and to review the outcomes of repeat treatments with CCH for recurrent contracture. MATERIALS AND METHODS: An institutional review board-approved retrospective chart review was conducted for patients between 2010 and 2017 who received CCH injections for Dupuytren's contracture at a Veterans Affairs hospital. Demographics, comorbidities, affected finger and joint, pre/posttreatment contracture, time to recurrence, and treatment of recurrence were recorded. Successful treatment was defined as contracture ≤5° following CCH, and improvement was defined as ≥20° reduction from baseline contracture. Study cohorts were followed after their secondary treatment, and time to recurrence was recorded and plotted using a Kaplan-Meier curve. A Cox proportional hazards model was used to compare treatment group risk factors for recurrence with a P-value less than .05 defined as statistical significance. RESULTS: Of 174 injections performed for the correction of flexion deformities in 109 patients, 70% (121) were successfully treated with CCH, and an additional 20% (35) had improvement. There was a recurrence of contractures in 43 joints (25%). Of these, 16 contractures were treated with repeat CCH, whereas another 16 underwent limited fasciectomy. In total, 75% (12 of 16) of the repeat CCH group and 75% of the fasciectomy group were successfully treated. Pre-injection contracture of ≥25° was found to be predictive of recurrence (P < .05). CONCLUSIONS: Initial treatment of contracture with CCH had a 70% success rate with 25% recurrence during the study period. Compared with limited fasciectomy, CCH had decreased efficacy. Based on the findings of this study, we believe that the treatment of primary and/or recurrent Dupuytren's contracture with CCH is a safe and less invasive alternative to fasciectomy in the era of telemedicine. CCH treatment requires no suture removal, which allows the ability to assess motion virtually, and the potential consequences of CCH treatment such as skin tears can be assessed and managed conservatively. In the veteran and active duty population, CCH can facilitate faster recovery and return to service. Strengths of this study include a large series of veteran populations with longitudinal follow-up to determine treatment efficacy for primary Dupuytren's contracture and recurrence. Limitations include a smaller sample size compared to previous trials, a lack of standardized follow-up, and the retrospective nature of our study that prohibits randomization to compare outcomes between CCH treatment and fasciectomy efficacy over time. Directions for future research include stratification of patients by joint and specific digit involvement as well as comparison with percutaneous needle fasciotomy, another minimally invasive technique that could benefit the veteran population at increased risk for developing Dupuytren's disease.

Initial Treatment Choice Affects Cost-Effectiveness and Reintervention Rates for Dupuytren Contracture: A National Census Among Veterans Affairs Patients.

BACKGROUND: A multitude of treatments for Dupuytren contracture are available, including both invasive and minimally invasive options. This study compares the reintervention rates and costs associated with various treatment options for Dupuytren disease (DD) within the Veterans Affairs (VA) Health Administration. METHODS: Using the Corporate Data Warehouse, a national census was performed including all patients treated for DD in years 2014 to 2020 within the VA health care system. Patients treated with collagenase clostridium histolyticum (CCH), percutaneous needle aponeurotomy (PNA), open fasciotomy, palmar fasciectomy, single finger fasciectomy, and multifinger fasciectomy were compared. The total cost of initial treatment was compared between modalities. The 5-year reintervention rates were compared using a Kaplan-Meier analysis. RESULTS: During the study period, 8530 patients were treated for DD (3501 fasciectomy, 3351 CCH, 880 PNA, 798 fasciotomy). The overall median treatment cost was found to be the least for PNA (P < .0001). The 5-year reintervention rates were significantly lower for single finger fasciectomy (6.5%), operative fasciotomy (8.2%), and palmar fasciectomy (9%) when compared with PNA (12.3%), multifinger fasciectomy (13.1%), and CCH (14.4%) (P < .001). However, reintervention rates were comparable between patients treated with PNA, multifinger fasciectomy, and CCH (P > .05). CONCLUSIONS: Within the VA population, PNA is the most affordable procedure per treatment episode and is associated with reintervention rates that are comparable to those of CCH. Multifinger fasciectomy, CCH, and PNA had comparable reintervention rates. The differences in reintervention rates may partially be explained by patients' willingness to consider additional treatment to correct any remaining or recurrent deformity.

Dupuytren Disease: Surgical Tips, Optimizing Outcomes, and Cost Considerations.

Dupuytren disease is associated with benign fibroproliferative changes to the palmar fascia of the hand sometimes resulting in progressive contractures of the fingers. The earliest descriptions of these contractures date back to the 18th century. Much has been learned about the condition since the clawing condition was first described; however, optimal treatment still poses significant challenges to modern-day surgeons. It is important to examine the treatment options for Dupuytren disease and highlight the current evidence, techniques, and cost considerations of open fasciectomy, needle aponeurotomy, and recently described minimally invasive treatment.

The CeCORD-J study on collagenase injection versus aponeurectomy for Dupuytren's contracture compared by hand function and cost effectiveness.

This study compared hand function and the cost-effectiveness of treatment between collagenase Clostridium histolyticum (CCH) injection and limited fasciectomy for patients with Dupuytren's contracture (DC). The CeCORD-J study is a prospective, multicenter, non-randomized controlled, observational study of two parallel groups. Participants were DC patients with multiple affected fingers, including flexion contracture of the proximal interphalangeal (PIP) joint. The primary outcome was the Hand10 score, as a patient-reported outcome measure (PROM). We set secondary outcomes of EQ-5D-5L (QOL) score, degree of extension deficit, and direct cost. Propensity score adjustment was used to balance differences in patient characteristics between groups. Participants comprised 52 patients in the Collagenase group and 26 patients in the Surgery group. There were no significant differences in the Hand10 and QOL scores between the two groups at 26 weeks. Mean direct cost was 248,000 yen higher in the Surgery group than in the Collagenase group. Extension deficit angle of the PIP joint was significantly larger in the Collagenase group at 26 weeks. Although the Collagenase group showed dominance in cost-effectiveness, there was no significant difference between the two groups in hand function at 26 weeks.

Dupuytren's interventions surgery versus collagenase (DISC) trial: study protocol for a pragmatic, two-arm parallel-group, non-inferiority randomised controlled trial.

BACKGROUND: Dupuytren's contracture is a fibro-proliferative disease of the hands affecting over 2 million UK adults, particularly the white, male population. Surgery is the traditional treatment; however, recent studies have indicated that an alternative to surgery-collagenase clostridium histolyticum (collagenase)-is better than a placebo in the treatment of Dupuytren's contracture. There is however no robust randomised controlled trial that provides a definitive answer on the clinical effectiveness of collagenase compared with limited fasciectomy surgery. Dupuytren's intervention surgery vs collagenase trial (DISC) trial was therefore designed to fill this evidence gap. METHODS/DESIGN: The DISC trial is a multi-centre pragmatic two-arm parallel-group, randomised controlled trial. Participants will be assigned 1:1 to receive either collagenase injection or surgery (limited fasciectomy). We aim to recruit 710 adult participants with Dupuytren's contracture. Potential participants will be identified in primary and secondary care, screened by a delegated clinician and if eligible and consenting, baseline data will be collected and randomisation completed. The primary outcome will be the self-reported patient evaluation measure assessed 1 year after treatment. Secondary outcome measures include the Unité Rhumatologique des Affections de la Main Scale, the Michigan Hand Questionnaire, EQ-5D-5L, resource use, further procedures, complications, recurrence, total active movement and extension deficit, and time to return to function. Given the limited evidence comparing recurrence rates following collagenase injection and limited fasciectomy, and the importance of a return to function as soon as possible for patients, the associated measures for each will be prioritised to allow treatment effectiveness in the context of these key elements to be assessed. An economic evaluation will assess the cost-effectiveness of treatments, and a qualitative sub-study will assess participants' experiences and preferences of the treatments. DISCUSSION: The DISC trial is the first randomised controlled trial, to our knowledge, to investigate the clinical and cost-effectiveness of collagenase compared to limited fasciectomy surgery for patients with Dupuytren's contracture. TRIAL REGISTRATION: Clinical.Trials.gov ISRCTN18254597 . Registered on April 11, 2017.

Return to Work and Associated Costs after Treatment for Dupuytren's Disease.

BACKGROUND: Return to work is potentially an important factor in assessing the success of treatment. However, little is known about the return to work after treatment for Dupuytren's contracture. Therefore, the primary aim of this study was to assess return to work after limited fasciectomy and percutaneous needle fasciotomy. METHODS: Patients who underwent either a limited fasciectomy or percutaneous needle fasciotomy were invited to complete a return-to-work questionnaire at 6 weeks, 3 months, 6 months, and 12 months postoperatively. Median time to return to work was assessed using inverted Kaplan-Meier curves, and hazard ratios were calculated with Cox regression models. Finally, a cost analysis was carried out using the human capital method to determine indirect costs associated with loss of productivity. RESULTS: The authors included 2698 patients in the study, of which 53 percent were employed at intake and included in the follow-up. After 1 year of follow-up, 90 percent of the patients had returned to work. Median time to return to work was 2 weeks after limited fasciectomy and within days after percutaneous needle fasciotomy. Furthermore, physically strenuous work, female sex, and higher age were associated with a longer time to return to work. Lost productivity per patient was estimated at €2614.43. CONCLUSIONS: The majority of patients returned to work after treatment for Dupuytren's disease. Return to work is much faster after percutaneous needle fasciotomy compared to limited fasciectomy. These findings can be used for more evidence-based preoperative counseling with patients with Dupuytren's disease.

Cost Analysis and National Trends in the Treatment of Dupuytren Contracture Comparing Collagenase Injection, Needle Fasciotomy, and Open Fasciectomy Procedures.

BACKGROUND: Dupuytren contracture (DC) is a common disorder characterized by progressive fibrosis of palmar fascia. This study analyzed cost trends of 3 common treatments for DC: fasciotomy, fasciectomy, and collagenase injection (CI)/cord manipulation. METHODS: The Vizient Clinical Data/Resource Manager electronic database was reviewed for all procedures for the treatment of DC at participating hospitals in the United States (US) from October 1, 2015, to September 1, 2019. Cases were placed into 1 of 3 categories: (1) CI, (2) needle fasciotomy (NF), and (3) open fasciectomy (OF). Total and direct costs were averaged for each procedure and compared nationally and regionally. Temporal trends and specific market share were analyzed. One-tailed t test and Pearson correlation analysis was performed (P < 0.05 and r > 0.9 or r < -0.9 was considered significant). RESULTS: A total of 22,974 total cases were identified. A total of 16,966 OF, 3962 NF, and 2046 CI were performed. There was a nearly a 4-fold increase in number of procedures to treat DC from 2015 to 2018. Market share percentage of each procedure stayed relatively similar over time. However, market share percentage differed between procedures. Needle fasciotomy had the lowest market share percentage approximately 7%. Collagenase injection had the highest average cost at US $4453.66 and was significantly higher than OF at US $3394.90 and NF at US $2010.75. Cost and distribution of procedures were further analyzed by geographic regions. In 2018, 32% of procedures performed were in the Northeastern US, 29% in the Midwestern US, 23% in the Southern US, and 16% in the Western US. Total number of Dupuytren procedures increased more than 300% in all regions across the US from 2015 to 2018. In every region, NF was the lowest cost intervention. Cost of OF and CI varied between regions and was often the most expensive intervention. CONCLUSIONS: Treatment of DCs with NF seems to be the least costly treatment option. Needle fasciotomy seems to be the least commonly performed procedure. Regional data show variations in the cost of OF and CI. However, OF has the majority market share nationally and regionally. Although the cost of these procedures seems to vary regionally, the type of procedures being performed seem to be similar across regions.

Cost-effectiveness of Recurrent Dupuytren Contracture Treatment.

Importance: Owing to its tendency to recur, Dupuytren contracture often requires multiple treatments, which places additional economic burden on health care. The likelihood of contracture recurrence varies not only with treatment but also with disease characteristics, such as contracture severity and location, but prior cost-effectiveness analyses of Dupuytren contracture treatments have not considered these patient-specific disease characteristics. Objective: To identify the most cost-effective treatment regimen for patients with recurrent Dupuytren contracture. Design, Setting, and Participants: This economic evaluation was conducted with state-transition microsimulation modeling using data from published studies and Medicare. A simulated cohort of 10 000 individuals with Dupuytren contracture was created. Patients could transition yearly between the following health states: symptom-free, symptomatic, and death. Available treatments were collagenase clostridium histolyticum injection, percutaneous needle aponeurotomy (PNA), and limited fasciectomy (LF); individuals randomly chose any treatment when symptomatic. Patients were limited to 3 rounds of treatment for a contracture affecting 1 joint, totaling 27 unique combinations. If the contracture recurred after 3 treatments, patients lived with the disease for the remainder of life. Exposures: PNA, collagenase clostridium histolyticum injection, or LF. Main Outcomes and Measures: Quality-adjusted life-years (QALYs), total costs (in US dollars), and incremental cost-effectiveness ratios (ICERs). A willingness-to-pay threshold of $100 000 per quality-adjusted life-year was used to assess cost-effectiveness. Results: For the base case scenario of a patient aged 60 years with recurrent, low-severity metacarpophalangeal (MCP) joint contracture, repeated PNA treatment was the only cost-effective treatment (2 PNA treatments followed by LF vs 3 PNA treatments, ICER [Monte Carlo SE]: $212 647/QALY [$36 000/QALY]). For recurrent high-severity MCP joint contractures, treatment regimens composed of PNA and LF were cost-effective (ICER [Monte Carlo SE], $93 932/QALY [$16 500/QALY]). LF was cost-effective for high-severity MCP joint contracture (ICER [Monte Carlo SE], $98 624/QALY [$26 233/QALY]). For recurrent proximal interphalangeal (PIP) joint contractures, PNA was the only cost-effective treatment, regardless of severity (eg, 2 PNA treatments followed by LF vs 3 PNA treatments for low-severity PIP joint contracture, ICER [Monte Carlo SE]: $263 726/QALY [$29 000/QALY]). Any combination with collagenase clostridium histolyticum injection compared with 3 PNA treatments had an ICER greater than $100 000 per QALY. Probabilistic sensitivity analysis estimated a 44%, 15%, 41%, and 52% chance of a regimen consisting of only PNA being cost-effective in low-severity MCP, high-severity MCP, low-severity PIP, and high-severity PIP joint contractures, respectively. Conclusions and Relevance: The results of this study suggest that LF is a cost-effective intervention for recurrent high-severity MCP joint contractures. For recurrent low-severity MCP joint contractures and PIP joint contractures of all severity levels, PNA was the only cost-effective intervention. Collagenase clostridium histolyticum injections were not a cost-effective intervention for recurrent Dupuytren contracture and should not be preferred over PNA or LF.

Fasciectomy under local anaesthetic and adrenaline for Dupuytren's contracture in a community setting in the UK with a cost analysis.

AIMS: In the UK, fasciectomy for Dupuytren's contracture is generally performed under general or regional anaesthetic, with an arm tourniquet and in a hospital setting. We have changed our practice to use local anaesthetic with adrenaline, no arm tourniquet, and perform the surgery in a community setting. We present the outcome of a consecutive series of 30 patients. METHODS: Prospective data were collected for 30 patients undergoing open fasciectomy on 36 digits (six having two digits affected), over a one-year period and under the care of two surgeons. In total, 10 ml to 20 ml volume of 1% lidocaine with 1:100,000 adrenaline was used. A standard postoperative rehabilitation regime was used. Preoperative health scores, goniometer measurements of metacarpophalangeal (MCP), proximal interphalangeal (PIP) contractures, and Unité Rheumatologique des Affections de la Main (URAM) scores were measured pre- and postoperatively at six and 12 weeks. RESULTS: The mean preoperative contractures were 35.3° (0° to 90°) at the metacarpophalangeal joint (MCPJ), 32.5° (0° to 90°) at proximal interphalangeal joint (PIPJ) (a combined deformity of 67.8°). The mean correction was 33.6° (0° to 90°) for the MCPJ and 18.2° (0° to 70°) for the PIPJ leading to a combined correction of 51.8°. There was a complete deformity correction in 21 fingers (59.5%) and partial correction in 14 digits (37.8%) with no correction in one finger. The mean residual deformities for the partial/uncorrected group were MCP 4.2° (0° to 30°), and PIP 26.1° (0° to 85°). For those achieving a full correction the mean preoperative contracture was less particularly at the PIP joint (15.45° (0° to 60°) vs 55.33° (0° to 90°)). Mean preoperative URAM scores were higher in the fully corrected group (17.4 (4 to 31) vs 14.0 (0 to 28)), but lower at three months post-surgery (0.5 (0 to 3) vs 4.40 (0 to 18)), with both groups showing improvements. Infections occurred in two patients (three digits) and both were successfully treated with oral antibiotics. No other complications were noted. The estimated cost of a fasciectomy under local anaesthetic in the community was £184.82 per patient. The estimated hospital theatre costs for a fasciectomy was £1,146.62 under general anaesthetic (GA), and £1,085.30 under an axillary block. CONCLUSION: This study suggests that a fasciectomy performed under local anaesthetic with adrenaline and without an arm tourniquet and in a community setting is safe, and results in favourable outcomes regarding the degree of correction of contracture achieved, functional scores, and short-term complications. Local anaesthetic fasciectomy in a community setting achieves a saving of £961.80 for a GA and £900.48 for an axillary block per case. Cite this article: Bone Joint J 2020;102-B(10):1354-1358.

Outcomes and Direct Costs of Needle Aponeurotomy, Collagenase Injection, and Fasciectomy in the Treatment of Dupuytren Contracture.

PURPOSE: The aims of our study were to evaluate the rates and predictors of reinterventions and direct costs of 3 common treatments of Dupuytren contractures-needle aponeurotomy, collagenase injection, and surgical fasciectomy. METHODS: A retrospective review identified 848 interventions for Dupuytren contracture in 350 patients treated by a single surgeon from 2005 to 2016. The treatments included needle aponeurotomy (NA) (n = 444), collagenase injection (n = 272), and open fasciectomy (n = 132). We collected information on demographics, contracture details, and comorbidities. Outcomes included reintervention rates, time to reintervention, and direct cost of treatments. Standardized costs were calculated by applying 2017 Medicare reimbursement to professional services and cost-to-charge ratios to hospital charges. RESULTS: Demographics were similar among the 3 treatment groups. The fifth finger was the most commonly affected digit including 43% of the NA, 60% of the collagenase, and 45% of the fasciectomy groups. The 2-year rates of reintervention following NA, collagenase, and fasciectomy were 24%, 41%, and 4%, respectively, and the 5-year rates were 61%, 55%, and 4%, respectively. Younger age and severity of preintervention proximal interphalangeal (PIP) joint contracture were predictive of reintervention in the NA and collagenase groups. The standardized direct costs for NA, collagenase, and fasciectomy were $624, $4,189, and $5,291, respectively. Including all reinterventions, the cumulative costs per digit following NA, collagenase, and surgery at 5 years were $1,540, $5,952, and $5,507, respectively. CONCLUSIONS: Treatment with collagenase resulted in the highest rate of reintervention at 2 years, comparable reintervention rates to NA at 5 years, and the highest cumulative costs. The NA was the least expensive and resulted in longer duration before reintervention compared with collagenase. More severe PIP joint contractures and younger age at time of initial intervention were predictive of reintervention after collagenase and NA. Fasciectomy has a high initial cost but the lowest reintervention rate. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.

DupuytrEn Treatment EffeCtiveness Trial (DETECT): a protocol for prospective, randomised, controlled, outcome assessor-blinded, three-armed parallel 1:1:1, multicentre trial comparing the effectiveness and cost of collagenase clostridium histolyticum, percutaneous needle fasciotomy and limited fasciectomy as short-term and long-term treatment strategies in Dupuytren's contracture.

INTRODUCTION: Dupuytren's contracture (DC) is a chronic fibroproliferative disorder of the palmar fascia which leads to flexion contracture in one or more fingers. There is no definitive cure for DC, and treatment aims at relieving symptoms by releasing the contracture using percutaneous or operative techniques. METHODS AND ANALYSIS: We planned a prospective, randomised, controlled, outcome assessor-blinded, three-armed parallel 1:1:1, multicentre trial comparing the effectiveness and cost of (1) collagenase clostridium histolyticum injection followed by limited fasciectomy in non-responsive cases, (2) percutaneous needle fasciotomy followed by limited fasciectomy in non-responsive cases and (3) primary limited fasciectomy during short-term and long-term follow-up for Tubiana I-III stages DC. We will recruit participants from seven national centres in Finland. Primary outcome is the rate of success in the treatment arm at 5 years after recruitment. Success is a composite outcome comprising (1) at least 50% contracture release from the date of recruitment and (2) participants in a patient-accepted symptom state (PASS). Secondary outcomes are (1) angle of contracture, (2) quick disabilities of the arm, a shoulder and hand outcome measure (QuickDASH), (3) perceived hand function, (4) EQ-5D-3L, (5) rate of major adverse events, (6) patient's trust of the treatment, (7) global rating, (8) rate of PASS, (9) rate of minimal clinically important improvement, (10) expenses, (11) progression of disease, (12) progression-free survival, (13) favoured treatment modality, (14) patients achieving full contracture release and >50% improvement and (15) patient satisfaction with the treatment effect. Predictive factors for achieving the PASS will also be analysed. ETHICS AND DISSEMINATION: The protocol was approved by the Tampere University Hospital Institutional Review Board and Finnish Medicine Agency. The study will be performed according to the principles of good clinical practice. The results of the trial will be disseminated as published articles in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03192020; Pre-results.

A feasibility study investigating the acceptability and design of a multicentre randomised controlled trial of needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren's contractures of the fingers (HAND-1): study protocol for a randomised controlled trial.

BACKGROUND: Dupuytren's contractures are fibrous cords under the skin of the palm of the hand. The contractures are painless but cause one or more fingers to curl into the palm, resulting in loss of function. Standard treatment within the NHS is surgery to remove (fasciectomy) or divide (fasciotomy) the contractures, and the treatment offered is frequently determined by surgeon preference. This study aims to determine the feasibility of conducting a large, multicentre randomised controlled trial to assess the clinical and cost-effectiveness of needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren's contracture. METHODS/DESIGN: HAND-1 is a parallel, two-arm, multicentre, randomised feasibility trial. Eligible patients aged 18 years or over who have one or more fingers with a Dupuytren's contracture of more than 30° in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joints, well-defined cord(s) causing contracture, and have not undergone previous surgery for Dupuytren's on the same hand will be randomised (1:1) to treatment with either needle fasciotomy or limited fasciectomy. Participants will be followed-up for up to 6 months post surgery. Feasibility outcomes include number of patients screened, consented and randomised, adherence with treatment, completion of follow-up and identification of an appropriate patient-reported outcome measure (PROM) to use as primary outcome for a main trial. Embedded qualitative research, incorporating a QuinteT Recruitment Intervention, will focus on understanding and optimising the recruitment process, and exploring patients' experiences of trial participation and the interventions. DISCUSSION: This study will assess whether a large multicentre trial comparing the clinical and cost-effectiveness of needle fasciotomy and limited fasciectomy for the treatment of Dupuytren's contractures is feasible, and if so will provide data to inform its design and successful conduct. TRIAL REGISTRATION: International Standard Registered Clinical/soCial sTudy Number: ISRCTN11164292 . Registered on 28 August 2015.

Dupuytren's disease: my personal view.

Dupuytren's disease is a heterogenous condition for which a palette of treatment options is required. Randomized control trial evidence is sparse; design challenges, such as validated outcome measures, blinding, equipoise, funding and assessment of recurrence, may limit further data accrual. Recurrence has different significance with different treatments and so rates are not directly comparable. The risk of any treatment is a function of both the chance of a complication and the clinical sequelae of that complication. The patient must be intimately involved in choosing treatment and is often trading rapid recovery for a higher chance of recurrence. Health economies are strained and as custodians of healthcare, surgeons should consider whether many patients even need treatment. To minimize the chance of complex, hazardous and expensive revision surgery, a low threshold for primary skin grafting should be applied, especially for those who are young, have dense disease or vulnerable genes.

Collagenase clostridium histolyticum for the treatment of Dupuytren's contracture: systematic review and economic evaluation.

BACKGROUND: Dupuytren's disease is a slowly progressive condition of the hand, characterised by the formation of nodules in the palm that gradually develop into fibrotic cords. Contracture of the cords produces deformities of the fingers. Surgery is recommended for moderate and severe contractures, but complications and/or recurrences are frequent. Collagenase clostridium histolyticum (CCH) has been developed as a minimally invasive alternative to surgery for some patients. OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of collagenase as an alternative to surgery for adults with Dupuytren's contracture with a palpable cord. DATA SOURCES: We searched all major electronic databases from 1990 to February 2014. REVIEW METHODS: Randomised controlled trials (RCTs), non-randomised comparative studies and observational studies involving collagenase and/or surgical interventions were considered. Two reviewers independently extracted data and assessed risk of bias of included studies. A de novo Markov model was developed to assess cost-effectiveness of collagenase, percutaneous needle fasciotomy (PNF) and limited fasciectomy (LF). Results were reported as incremental cost per quality-adjusted life-year (QALY) gained. Deterministic and probabilistic sensitivity analyses were undertaken to investigate model and parameter uncertainty. RESULTS: Five RCTs comparing collagenase with placebo (493 participants), three RCTs comparing surgical techniques (334 participants), two non-randomised studies comparing collagenase and surgery (105 participants), five non-randomised comparative studies assessing various surgical procedures (3571 participants) and 15 collagenase case series (3154 participants) were included. Meta-analyses of RCTs assessing CCH versus placebo were performed. Joints randomised to collagenase were more likely to achieve clinical success. Collagenase-treated participants experienced significant reduction in contracture and an increased range of motion compared with placebo-treated participants. Participants treated with collagenase also experienced significantly more adverse events, most of which were mild or moderate. Four serious adverse events were observed in the collagenase group: two tendon ruptures, one pulley rupture and one complex regional pain syndrome. Two tendon ruptures were also reported in two collagenase case series. Non-randomised studies comparing collagenase with surgery produced variable results and were at high risk of bias. Serious adverse events across surgery studies were low. Recurrence rates ranged from 0% (at 90 days) to 100% (at 8 years) for collagenase and from 0% (at 2.7 years for fasciectomy) to 85% (at 5 years for PNF) for surgery. The results of the de novo economic analysis show that PNF was the cheapest treatment option, whereas LF generated the greatest QALY gains. Collagenase was more costly and generated fewer QALYs compared with LF. LF was £1199 more costly and generated an additional 0.11 QALYs in comparison with PNF. The incremental cost-effectiveness ratio was £10,871 per QALY gained. Two subgroup analyses were conducted for a population of patients with moderate and severe disease and up to two joints affected. In both subgroup analyses, collagenase remained dominated. LIMITATIONS: The main limitation of the review was the lack of head-to-head RCTs comparing collagenase with surgery and the limited evidence base for estimating the effects of specific surgical procedures (fasciectomy and PNF). Substantial differences across studies further limited the comparability of available evidence. The economic model was derived from a naive indirect comparison and was hindered by a lack of suitable data. In addition, there was considerable uncertainty about the appropriateness of many assumptions and parameters used in the model. CONCLUSIONS: Collagenase was significantly better than placebo. There was no evidence that collagenase was clinically better or worse than surgical treatments. LF was the most cost-effective choice to treat moderate to severe contractures, whereas collagenase was not. However, the results of the cost-utility analysis are based on a naive indirect comparison of clinical effectiveness, and a RCT is required to confirm or refute these findings. STUDY REGISTRATION: This study is registered as PROSPERO CRD42013006248. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Impact on costs of switching one-ray aponeurectomy to percutaneous needle aponeurotomy in Dupuytren's disease: A model analysis.

OBJECTIVE: To assess the cost of switching surgical aponeurectomy to percutaneous needle aponeurotomy in one-ray Dupuytren's disease. METHODS: A model analysis was performed with a cross-sectional national survey of public and private French hospitals in 2012. All stays for one-ray aponeurectomy were "virtually" replaced with 1, 2 or 3 outpatient sessions of percutaneous needle aponeurotomy. The costs were based on the hospital cost (tariff per disease-related group) and on common classification of medical procedures performed in outpatient care for 2013. RESULTS: Dupuytren's disease represented 18,707 hospitalizations (€26 million [2013 euros]) in France in 2012, 8534 hospitalizations for one-ray aponeurectomy (€11.9 million). By replacing surgical aponeurectomy with percutaneous needle aponeurotomy for one-ray Dupuytren's disease, 91% to 97% and 56% to 59% of the treatment costs could be saved using hospitalizations for one-ray aponeurectomy or total hospital costs, respectively, as reference. CONCLUSIONS: Replacing aponeurectomy with percutaneous needle aponeurotomy for one-ray Dupuytren's disease could greatly reduce the treatment costs for all Dupuytren's disease. Effective alternatives to surgery for Dupuytren's disease, such as needle aponeurotomy in an outpatient setting should be considered in the economic perspective.

Linear regression analysis of Hospital Episode Statistics predicts a large increase in demand for elective hand surgery in England.

INTRODUCTION: We integrated two factors, demographic population shifts and changes in prevalence of disease, to predict future trends in demand for hand surgery in England, to facilitate workforce planning. METHODS: We analysed Hospital Episode Statistics data for Dupuytren's disease, carpal tunnel syndrome, cubital tunnel syndrome, and trigger finger from 1998 to 2011. Using linear regression, we estimated trends in both diagnosis and surgery until 2030. We integrated this regression with age specific population data from the Office for National Statistics in order to estimate how this will contribute to a change in workload over time. RESULTS: There has been a significant increase in both absolute numbers of diagnoses and surgery for all four conditions. Combined with future population data, we calculate that the total operative burden for these four conditions will increase from 87,582 in 2011 to 170,166 (95% confidence interval 144,517-195,353) in 2030. DISCUSSION: The prevalence of these diseases in the ageing population, and increasing prevalence of predisposing factors such as obesity and diabetes, may account for the predicted increase in workload. The most cost effective treatments must be sought, which requires high quality clinical trials. Our methodology can be applied to other sub-specialties to help anticipate the need for future service provision.

Surgical treatment of Dupuytren's disease - outcome and health economy in relation to smoking and diabetes.

BACKGROUND: The conventional treatment for Dupuytren's disease is surgery. The introduction of alternative treatment strategies creates a need to track outcomes and costs relating to surgical treatment and risk factors, such as smoking and diabetes. This was the aim of the present study. METHODS: In a prospective study, the outcome of open surgical treatment for finger flexion contracture in Dupuytren's disease (175 patients; 182 surgical procedures) was studied by evaluating valid QuickDASH forms answered by subjects before surgery and one year postoperatively. Data were also obtained from medical records, and preoperative declarations concerning health. RESULTS: In all subjects (median [25% - 75% percentiles] age 68 [62-73]), the QuickDASH score improved from 22 [9-36] to 5 [0-18]. Smokers (27/179 procedures) were younger and had a more severe degree of disease and dysfunction preoperatively than non-smokers, but the outcome of surgery did not differ between the groups. Subjects with diabetes (20/181 procedures) were younger than those without diabetes, but their disease severity or outcome did not differ. Hand specialists operated faster than residents, but the surgical outcome did not differ. Healthcare costs for surgery for Dupuytren's contracture were $ 2392 (€ 1859), which were not higher among smokers or subjects with diabetes. Only 22 patients remained in hospital (2 [1-2.3] days) and 28 patients needed sick leave (28 [21-31] days). The occurrence of necrosis of skin flaps (12%) or infections (6%) was no more frequent among smokers or those with diabetes. CONCLUSIONS: There is no difference in surgical outcome for finger flexion contracture in Dupuytren's disease between smokers and non-smokers or between subjects with or without diabetes, although smokers had more severe preoperative contracture. The costs for surgical treatment for finger flexion contracture in Dupuytren's disease should be viewed in relation to that for other treatment strategies.

Three-dimensional assessment of hand outcome.

INTRODUCTION: Patient reported outcome measures are central to National Health Service quality of care assessments. This study investigated the benefit of elective hand surgery by the simultaneous analysis of pain, function and appearance, using a three-dimensional (3D) graphical model for evaluating and presenting outcome. METHODS: A total of 188 patients scheduled for surgery completed pre- and postoperative questionnaires grading the severity of their pain, dysfunction and deformity of their hand(s). Scores were plotted on a 3D graph to demonstrate the degree of 'normalisation' following surgery. RESULTS: Surgical groups included: nerve compression (n=53), Dupuytren's disease (n=51), trigger finger (n=20), ganglion (n=17) or other lump (n=21), trapeziometacarpal joint osteoarthritis (n=10), rheumatoid disease (n=5) and other pathology (n=13). A significant improvement towards normality was seen after surgery in each group except for patients with rheumatoid disease. CONCLUSIONS: This study provides a simple, visual representation of hand surgery outcome by plotting patient scores for pain, function and appearance simultaneously on a 3D graph.

[Utilization of health care resources and cost associated to fasciectomy in Dupuytren's disease in Spain]. / Utilización de recursos sanitarios y costes asociados a la fasciectomía en la enfermedad de Dupuytren en España.

OBJECTIVE: To estimate the healthcare resource utilization and their associated costs secondary to fasciectomy of Dupuytren s disease (DD) treated under usual medical practice in Spain. METHODS: This multicenter, observational, retrospective cohort study, extracted data through the revision of medical records of three tertiary public hospitals. Each center should recruit 40 patients operated for DD, as principal diagnose of Minimum Data Set, in which the surgical procedure conducted was fasciectomy, during 2007-2009. To collect all the resources used during surgery, a specific chart form was designed. Demographic (age, gender, occupational status), clinical (stage of contracture and comorbilities) and healthcare utilization (hospitalizations, medical visits, tests, drugs) data were collected under medical routine. Comparisons between stage of contracture grouped (I: stage N, 1 & 2; II: stage 3 & 4) and centers were made. RESULTS: A total of 123 subjects (52% group I; 86.2% men; 35.8% active workers) were identified. 81.3% of patients presented at least one comorbidity, being hypertension the most frequent. 28.4% of patients were operated in ambulatory surgery and 71.6% hospitalized. All the patients had follow-up visits after surgery, 27% needed physical therapy, 88% performed preoperative tests and 8% visit the emergency room after surgery. Healthcare mean (SD) costs were as follows: fasciectomy €1,074 (0); hospitalizations €978 (743); ambulatory €186 (10); follow-up visits €260 (173); emergency rooms €13 (53); tests €78(43); drugs €7 (9); physical therapy €46 (134). Mean total costs were €2,250 (839). There were no significant differences between study groups grouped by stage of contracture. However, the center and the severity of the CD seem explanatory variables of cost, p<0.05. CONCLUSIONS: Healthcare resources utilization for surgical treatment of Dupuytren's disease may cost €2,250 (839) per fasciectomy treated under usual medical practice.