RESUMO
PURPOSE: To compare collagenase injection with surgical fasciectomy in Dupuytren disease (DD) for the prevalence of contracture in treated fingers 5 years after treatment. METHODS: This was a single-center, comparative cohort study comprising 2 cohorts of patients treated for DD in 1 or more of 3 ulnar fingers with collagenase injection (159 patients) or surgical fasciectomy (59 patients). At 5 years after treatment, 13 collagenase-treated and 8 fasciectomy-treated patients had undergone subsequent treatment on the treated fingers and were considered to have current contracture. Of the remaining patients, 112 collagenase-treated patients (128 hands, 180 fingers) and 46 fasciectomy-treated patients (49 hands, 63 fingers) attended follow-up evaluation performed by 2 independent examiners (participation rate 84% and 93%, respectively). We defined current contracture in a treated finger as an active extension deficit of ≥20° in the metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joint or a total (MCP + PIP) active extension deficit (TAED) of ≥30°. We used linear mixed models to analyze differences between the cohorts over time. RESULTS: In the collagenase cohort, current contracture was present in 45 (25%) MCP and 60 (33%) PIP joints, and in the fasciectomy cohort, current contracture was present in 12 MCP (19%) and 30 PIP (48%) joints; a TAED of ≥30° was present in 79 (44%) of the collagenase-treated and 30 (48%) of the fasciectomy-treated fingers. In MCP and PIP joints with ≥20° pretreatment contracture, complete correction was observed in 82 (56%) MCP and 30 (30%) PIP joints in the collagenase cohort and 23 (70%) MCP and 5 (16%) PIP joints in the fasciectomy cohort. There was no statistically significant difference between the 2 cohorts in the TAED change over time. CONCLUSIONS: In patients with DD, collagenase injection and surgical fasciectomy improved finger joint contracture over the pretreatment status but had a high prevalence of joint contracture in the treated fingers 5 years after treatment. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.
Assuntos
Contratura de Dupuytren , Luxações Articulares , Estudos de Coortes , Colagenases/uso terapêutico , Contratura de Dupuytren/tratamento farmacológico , Contratura de Dupuytren/cirurgia , Fasciotomia , Articulações dos Dedos/cirurgia , Humanos , Colagenase Microbiana/uso terapêutico , Resultado do TratamentoRESUMO
Background and purpose - Few prospective studies have reported the long-term effect durability of collagenase injections for Dupuytren disease. We assessed the 3-year treatment outcome of collagenase injections and predictors of recurrence.Patients and methods - We conducted a single-center prospective cohort study. Indication for collagenase injection was palpable Dupuytren's cord and active extension deficit (AED) ≥ 20° in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joint. From November 2012 through June 2013, we treated 86 consecutive patients (92 hands, 126 fingers). A hand therapist measured joint contracture before, 5 weeks, and 3 years after injection. The patients rated their treatment satisfaction. Primary outcome was proportion of treated joints with ≥ 20° AED worsening between the 5-week and 3-year measurements. We analyzed predictors of recurrence.Results - 3-year outcomes were available for 83 of the 86 patients (89 hands, 120 treated fingers). Between the 5-week and 3-year measurements, AED worsened by ≥ 20° in 17 MCP (14%) and 28 PIP (23%) joints. At 3 years, complete correction (passive extension deficit 0-5°) was present in 73% of MCP and 35% of PIP joints. Treatment of small finger PIP joint contracture, greater pretreatment contracture severity, and previous fasciectomy on the treated finger were statistically significant predictors of recurrence. Treatment satisfaction was rated as very satisfied or satisfied in 59 of 87 hands. No long-term treatment-related adverse events were observed.Interpretation - 3 years after collagenase injections for Dupuytren disease, improvement was maintained and treatment satisfaction reported in two-thirds of the treated hands, with no adverse events. Complete contracture correction was achieved in 3 of 4 MCP joints, but in only a third of the PIP joints.
Assuntos
Clostridium histolyticum , Contratura de Dupuytren/tratamento farmacológico , Colagenase Microbiana/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Contratura de Dupuytren/fisiopatologia , Feminino , Articulações dos Dedos/fisiopatologia , Humanos , Injeções , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Amplitude de Movimento Articular/fisiologia , Recidiva , Índice de Gravidade de DoençaRESUMO
BACKGROUND AND PURPOSE: Treatment of Dupuytren's contracture (DC) with collagenase Clostridium histolyticum (CCH) consists of injection followed by finger manipulation. We used a modified method, injecting a higher dose than recommended on the label into several parts of the cord, which allows treatment of multiple joint contractures in 1 session and may increase efficacy. We studied the occurrence of skin tears and short-term outcome with this procedure. PATIENTS AND METHODS: We studied 164 consecutive hands with DC, palpable cord, and extension deficit of ≥ 20º in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joint (mean patient age 70 years, 82% men). A hand surgeon injected all the content of 1 CCH vial (approximately 0.80 mg) into multiple spots in the cord and performed finger extension under local anesthesia after 1 or 2 days. A nurse recorded skin tears on a diagram and conducted a standard telephone follow-up within 4 weeks. A hand therapist measured joint contracture before injection and at a median of 23 (IQR: 7-34) days after finger extension. RESULTS: A skin tear occurred in 66 hands (40%). The largest diameter of the tear was ≤ 5 mm in 30 hands and > 10 mm in 14 hands. Hands with skin tear had greater mean pretreatment MCP extension deficit than those without tear: 59º (SD 26) as opposed to 32º (SD 23). Skin tear occurred in 21 of 24 hands with MCP contracture of ≥ 75º. All tears healed with open-wound treatment. No infections occurred. Mean improvement in total (MCP + PIP) extension deficit was 55º (SD 28). INTERPRETATION: Skin tears occurred in 40% of hands treated with collagenase injections, but only a fifth of them were larger than 1 cm. Tears were more likely in hands with severe MCP joint contracture. All tears healed without complications. Short-term contracture reduction was good.
Assuntos
Clostridium histolyticum/enzimologia , Colagenases/administração & dosagem , Colagenases/uso terapêutico , Contratura de Dupuytren/tratamento farmacológico , Injeções/métodos , Idoso , Estudos de Coortes , Contratura de Dupuytren/fisiopatologia , Feminino , Articulações dos Dedos/efeitos dos fármacos , Articulações dos Dedos/fisiopatologia , Seguimentos , Humanos , Incidência , Injeções/efeitos adversos , Entrevistas como Assunto , Masculino , Articulação Metacarpofalângica/efeitos dos fármacos , Articulação Metacarpofalângica/fisiopatologia , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Risco , Pele/lesões , Resultado do TratamentoRESUMO
BACKGROUND: Patients with Dupuytren disease experience various activity limitations. Treatment aims to reduce finger joint contractures to improve hand function and activity performance. For assessing improvement different patient-centered measures have been used. The Canadian Occupational Performance Measure (COPM) was developed as an interview-based outcome measure to detect changes over time in patients' perception of their performance and satisfaction in self-identified activity issues. The 11-item disabilities of the arm, shoulder and hand (QuickDASH) scale consists of fixed items that ask patients to rate the difficulty in performing specific daily activities. Few studies have compared the responsiveness of these two types of patient-reported measures in Dupuytren disease. PATIENTS AND METHODS: We included 30 patients with Dupuytren disease enrolled in a prospective cohort study of collagenase injection. We used the COPM (score range 1-10), the QuickDASH (score range 0-100) and measurement of finger joint contracture before and 5 weeks after treatment. RESULTS: Using the COPM the patients identified 107 activity problems (55 in self-care, 19 in productivity and 33 in leisure). The two most common activity problems were to wash self (21 patients) and to don gloves (19 patients). A clinically important improvement with 3 points or greater from baseline to 5 weeks was seen for performance in 77 activities (72%). The median COPM performance score improved from 4.4 at baseline to 9.0 at 5 weeks and the median QuickDASH score improved from 13.6 to 2.5. Responsiveness (Cohen's d) for the COPM performance was 2.6 (95% CI 1.9-3.3) and for the QuickDASH 0.6 (95% CI 0.1-1.1). CONCLUSION: The COPM had about 6-fold larger responsiveness than the QuickDASH, which supports use of an individualized measure when assessing treatment effects in Dupuytren disease.
Assuntos
Contratura de Dupuytren , Terapia Ocupacional , Humanos , Contratura de Dupuytren/terapia , Atividades Cotidianas , Estudos Prospectivos , CanadáRESUMO
In Dupuytren disease, little is known about the long-term outcomes of collagenase injection or risk factors for contracture recurrence. In this prospective study, 159 patients (242 fingers) with Dupuytren disease and active extension deficit (AED) ≥20° in a metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joint were treated with collagenase injection during a 14-month period. At 5 years, 18 patients were deceased, 2 could not be contacted, and 13 had undergone fasciectomy. The remaining 126 patients (199 treated fingers) participated in a follow-up evaluation at 52-96 (mean 65) months after injection, with physical examination (114 patients) or telephone interview (12 patients). Recurrence was defined as subsequent treatment (surgery or repeat injection) or ≥20° AED worsening in a treated joint between the 6-week and 5-year measurements. The mean AED at baseline was 42° (SD 24) for MCP joints and 31° (SD 29) for PIP joints and at 5 years 11° (SD 17) and 17° (SD 23), respectively. Recurrence occurred in 17% of MCP joints and 25% of PIP joints. Statistically significant risk factors for PIP joint contracture recurrence were greater baseline AED (odds ratio 1.04, 95% CI 1.02-1.06) and small finger treatment (OR 4.6, 95% CI 1.5-14.3), with no significant risk factors found for MCP contracture recurrence.
RESUMO
INTRODUCTION: There is no definitive cure for Dupuytren disease (DD), and recurrence of finger contractures after treatment is common. Surgical fasciectomy is considered the standard treatment method for recurrence, although associated with a high incidence of complications. Collagenase injection, a non-surgical treatment option, has been shown to be a safe and effective method; however, most studies regarding collagenase have involved first-time treatment. Collagenase efficacy in patients with recurrent DD beyond the immediate effect has not yet been determined. The aim of our study is to compare surgical fasciectomy and collagenase injection in treating recurrent DD. METHODS AND ANALYSIS: The study is a single-centre randomised controlled trial. Inclusion criteria are recurrence of DD in one or more fingers after previous treatment with fasciectomy or collagenase injection, a passive extension deficit ≥30° in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joint, and a palpable cord causing the recurrent contracture. A total of 56 patients will be randomised to either surgical fasciectomy or collagenase injection. A hand therapist blinded to patients' group allocation will measure range of motion at baseline, 3 months, 12 months, 24 months and 60 months. The primary outcomes are the total active extension deficit (MCP plus PIP) at 3 months and the proportion of patients with contracture worsening ≥20° in the treated finger joint at 2 years compared with 3 months. The secondary outcomes include changes in total active motion, active and passive extension deficit from baseline up to 5 years, scores on patient-reported outcome measures, adverse events and costs of treatment. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Regional Ethical Review Board, Lund University, Sweden(2017/623). The trial will be conducted according to the Helsinki Declaration of 1975, revised in 2000. The results of the trial will be disseminated as published articles in peer-reviewed journals. TRIAL REGISTRATION: NCT03406338; Pre-results.
Assuntos
Colagenases/uso terapêutico , Contratura de Dupuytren/terapia , Fasciotomia , Adulto , Protocolos Clínicos , Colagenases/administração & dosagem , Contratura de Dupuytren/tratamento farmacológico , Contratura de Dupuytren/cirurgia , Fasciotomia/métodos , Humanos , Injeções , RecidivaRESUMO
OBJECTIVES: To assess 2-year durability of joint contracture correction following collagenase injections for Dupuytren's disease. DESIGN: Prospective cohort study. SETTING: Orthopaedic Department in Sweden. PARTICIPANTS: Patients with palpable Dupuytren's cord and active extension deficit (AED) ≥30° in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joint. A surgeon injected 0.80â mg collagenase into multiple cord parts and performed finger manipulation under local anaesthesia after 24-48â hours. A hand therapist measured joint contracture before and 5â weeks after injection in all treated patients. Of 57 consecutive patients (59 hands), 48 patients (50 hands) were examined by a hand therapist 24-35â months (mean 26) after injection. Five of the patients had received a second injection in the same finger within 6â months of the first injection. OUTCOME MEASURES: Primary outcome was proportion of treated joints with ≥20° worsening in AED from 5â weeks to 2â years. RESULTS: Between the 5-week and the 2-year measurements, AED had worsened by ≥20° in seven MCP and seven PIP joints (28% of the treated hands; all had received a single injection). Mean AED for the MCP joints was 54° before injection, 6° at 5â weeks and 9° at 2â years and for the PIP joints 30°, 13° and 16°, respectively. For joints with ≥10° contracture at baseline, mean (95 % CI) baseline to 2â years AED improvement was for MCP 49° (41-54) and for PIP 25° (17-32). No treatment-related adverse events were observed at the 2-year follow-up evaluation. CONCLUSIONS: Two years after collagenase injections for Dupuytren's disease, improvement was maintained in 72% of the treated hands. Complete contracture correction was seen in more than 80% of the MCP but in less than half of the PIP joints.
Assuntos
Colagenases/uso terapêutico , Contratura de Dupuytren/tratamento farmacológico , Articulações dos Dedos , Mãos/patologia , Articulação Metacarpofalângica , Idoso , Idoso de 80 Anos ou mais , Colagenases/administração & dosagem , Feminino , Humanos , Injeções , Masculino , Pessoa de Meia-Idade , Recidiva Local de Neoplasia , Estudos Prospectivos , Resultado do TratamentoRESUMO
OBJECTIVES: To compare collagenase injections and surgery (fasciectomy) for Dupuytren's contracture (DC) regarding actual total direct treatment costs and short-term outcomes. DESIGN: Retrospective cohort study. SETTING: Orthopaedic department of a regional hospital in Sweden. PARTICIPANTS: Patients aged 65 years or older with previously untreated DC of 30° or greater in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joints of the small, ring or middle finger. The collagenase group comprised 16 consecutive patients treated during the first 6 months following the introduction of collagenase as treatment for DC at the study centre. The controls were 16 patients randomly selected among those operated on with fasciectomy at the same centre during the preceding 3 years. INTERVENTIONS: Treatment with collagenase was given during two standard outpatient clinic visits (injection of 0.9 mg, distributed at multiple sites in a palpable cord, and next-day finger extension under local anaesthesia) followed by night-time splinting. Fasciectomy was carried out in the operating room (day surgery) under general or regional anaesthesia using standard technique, followed by therapy and splinting. PRIMARY AND SECONDARY OUTCOME MEASURES: Actual total direct costs (salaries of all medical personnel involved in care, medications, materials and other relevant costs), and total MCP and PIP extension deficit (degrees) measured by hand therapists at 6-12 weeks after the treatment. RESULTS: Collagenase injection required fewer hospital outpatient visits to a therapist and nurse than fasciectomy. Total treatment cost for collagenase injection was US$1418.04 and for fasciectomy US$2102.56. The post-treatment median (IQR) total extension deficit was 10 (0-30) for the collagenase group and 10 (0-34) for the fasciectomy group. CONCLUSIONS: Treatment of DC with one collagenase injection costs 33% less than fasciectomy with equivalent efficacy at 6 weeks regarding reduction in contracture.