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Additional Treatment after Collagenase Injections and Needle Fasciotomy for Dupuytren's Disease: A Retrospective Cohort Study.

ABSTRACT: Introduction The aim of this study was to assess the rate of additional treatment after collagenase injection and needle fasciotomy, and what factors are associated with additional procedures for recurrence. Materials and Methods We retrospectively identified 201 adult patients who underwent collagenase injection and 19 patients who underwent needle fasciotomy for Dupuytren's disease from 2012 to 2014. Outcomes included additional treatment of the same ray for either recurrence or persistence of contracture. To evaluate associated factors, we performed a bivariate analysis. Results Additional treatment after collagenase injection for recurrence was performed in 24% of fingers at a median of 23 months (interquartile range [IQR]: 10.8-36.1) and was associated with bilateral disease ( p = 0.008). Additional treatment for persistence was performed in 5.6% at a median of 1.9 months (IQR: 1.1-3.2). Additional treatment for recurrence after needle fasciotomy was performed in 13% of fingers at a median of 28.2 months (IQR: 27.5-28.2) and 4.2% for persistence at 1.1 months. Fingers treated with needle fasciotomy were more likely to undergo secondary open fasciectomy (13% vs. 5.1%, p = 0.022). Conclusion Additional treatment after collagenase injections was performed in 29% of fingers, mostly another collagenase injection, and was associated with bilateral disease. After needle fasciotomy, 17% of patients underwent additional treatment, primarily open partial fasciectomy.

SUBMITTER: Arnold DMJ

PROVIDER: S-EPMC9500384 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature

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Additional Treatment after Collagenase Injections and Needle Fasciotomy for Dupuytren's Disease: A Retrospective Cohort Study.

Arnold Denise M J DMJ Lans Jonathan J Westenberg Ritsaart R Lunn Kiera K Blazar Philip P Chen Neal C NC

Journal of hand and microsurgery 20200726 2

<b>Introduction</b> The aim of this study was to assess the rate of additional treatment after collagenase injection and needle fasciotomy, and what factors are associated with additional procedures for recurrence. <b>Materials and Methods</b> We retrospectively identified 201 adult patients who underwent collagenase injection and 19 patients who underwent needle fasciotomy for Dupuytren's disease from 2012 to 2014. Outcomes included additional treatment of the same ray for either recurrence o ...[more]

PMID: 36159071

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Project description:ObjectivesTo compare collagenase injections and surgery (fasciectomy) for Dupuytren's contracture (DC) regarding actual total direct treatment costs and short-term outcomes.DesignRetrospective cohort study.SettingOrthopaedic department of a regional hospital in Sweden.ParticipantsPatients 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.InterventionsTreatment 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 measuresActual 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.ResultsCollagenase 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.ConclusionsTreatment of DC with one collagenase injection costs 33% less than fasciectomy with equivalent efficacy at 6 weeks regarding reduction in contracture.

Project description:PurposeThe purpose of this study is to assess the feasibility of conducting a large, multicentre randomised controlled trial (RCT) comparing needle fasciotomy with limited fasciectomy for treatment of Dupuytren's contractures.DesignThe design of this study is a parallel, two-arm, multicentre, randomised feasibility trial with embedded QuinteT Recruitment Intervention.ParticipantsPatients aged 18 years or over who were referred from primary to secondary care for treatment of a hand with Dupuytren's contractures of one or more fingers of more than 30° at the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joints and well-defined cord(s). Patients were excluded if they had undergone previous Dupuytren's contracture surgery on the same hand.MethodsPotential participants were screened for eligibility. Recruited participants randomised (1:1) to treatment with either needle fasciotomy or limited fasciectomy and followed-up for up to 6 months after treatment. Data on recruitment rates, completion of follow-up, and procedure costs were collected. Four patient reported outcome measures (PROMs) and objective outcome measures were collected before intervention and 6 weeks and 6 months afterwards.ResultsOne hundred and fifty-three of 267 (57%) primary-care referrals for Dupuytren's contractures met the eligibility criteria for the study. Seventy-one of the 153 (46%) agreed to participate and were randomly allocated to treatment with needle fasciotomy or limited fasciectomy. Sixty-seven of these underwent their allocated treatment, two were crossovers from limited fasciectomy to needle fasciotomy, and two (both allocated limited fasciectomy) received no treatment. Fifty-nine participants (85%) completed 6-month follow-up PROMs. Participants felt the MYMOP, PEM and URAM PROMs allowed them to better describe how their treatment affected their hand function than the DASH PROM. The estimated costs of limited fasciectomy (in an operating theatre) and needle fasciotomy (in a clinic room) were £777 and £111 respectively.ConclusionA large RCT comparing treatment of Dupuytren's contractures by needle fasciotomy and limited fasciectomy is feasible. Data from this study will help determine the number of sites and duration of recruitment required to complete an adequately powered RCT and will assist the selection of PROMs in future studies on the treatment of Dupuytren's contractures. (Level 1 feasibility study).Trial registrationTrial registered with ISRCTN (registration number: ISRCTN11164292), date assigned - 28/08/2015.

Project description:BackgroundTreatments for Dupuytren's contracture include limited fasciectomy and collagenase injection. Comparisons of the effectiveness of these treatments have been limited.MethodsWe performed an unblinded, multicenter, pragmatic, two-group, randomized, controlled noninferiority trial comparing collagenase injection with limited fasciectomy in persons with moderate Dupuytren's contracture. The primary outcome was the score on the Patient Evaluation Measure-Hand Health Profile (PEM), a questionnaire for assessing hand health as reported by the patient, at 1 year after treatment. Scores on the PEM range from 0 to 100, with higher scores indicating worse outcomes. The prespecified noninferiority margin was 6 points.ResultsA total of 672 persons (336 per group) were assigned to receive collagenase injection or to undergo limited fasciectomy. The primary analysis included 599 persons: 314 in the collagenase group and 285 in the limited-fasciectomy group. The mean score on the PEM at 1 year was 17.8 among the 284 patients with available data in the collagenase group and 11.9 among the 250 patients with available data in the limited-fasciectomy group (estimated difference, 5.9 points; 95% confidence interval [CI], 3.1 to 8.8; one-sided P = 0.49 for noninferiority). Among the patients with available data (229 patients in the collagenase group and 197 patients in the limited-fasciectomy group), the estimated difference in the mean score on the PEM at 2 years was 7.2 points (95% CI, 4.2 to 10.9). Moderate or severe complications of treatment occurred in 1.8% of the patients in the collagenase group and in 5.1% of those in the limited-fasciectomy group; recurrent contracture resulted in reintervention in 14.6% and 3.4%, respectively.ConclusionsCollagenase injection was not noninferior to limited fasciectomy with respect to the score on the PEM at 1 year after treatment. (Funded by the National Institute for Health and Care Research Health Technology Assessment Programme; DISC ISRCTN Registry number ISRCTN18254597.).

Project description: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.

Project description:BackgroundDupuytren's contracture (DC) is a fibrotic hand condition in which one or more fingers develop progressive flexion deformities. Quality of life is diminished due to disabling limitations in performing everyday activities. For DC patients treated with collagenase, referral for subsequent hand therapy is inconsistent. It is unknown whether subsequent hand therapy is beneficial compared to no therapy. The purpose of this study is to determine whether hand therapy improves DC patients' performance of and satisfaction with performing everyday activities one year after collagenase treatment.MethodsWe will conduct a randomised controlled trial with two treatment groups (hand therapy vs. control) of DC patients who have received collagenase treatment. DC patients with contracted metacarpophalangeal joint(s) (MCPJ) (hand therapy, n = 40; control, n = 40) and those with proximal interphalangeal joint(s) (PIPJ) involvement (hand therapy, n = 40; control, n = 40) comprise two subgroups, and we will study if the treatment effect will be different between both groups (n = 160). Patients with a previous injury or treatment for DC in the treatment finger are excluded. Hand therapy includes oedema and scar management, splinting, movement exercises, and practice of everyday activities. The main outcome variable is patients' performance of and satisfaction with performing everyday activities, as assessed with the Canadian Occupational Performance Measure. Secondary outcomes are DC-specific activity problems, as assessed with the Unité Rhumatologique des Affections de la Main scale, and active/passive flexion/extension of treated joints and grip force using standard measuring tools, and self-reported pain level. Demographic and clinical variables, degree of scarring, cold hypersensitivity, number of occupational sick-leave days are collected. Self-reported global impression of change will be used to assess patient satisfaction with change in hand function. Assessments are done pre-injection and 6 weeks, 4 months, and 1 year later. Standard univariate and multivariate statistical analyses will be used to evaluate group differences.DiscussionThis study aims to assess whether hand therapy is beneficial for activity-related, biomechanical, and clinical outcomes in DC patients after collagenase treatment. The results will provide an objective basis for determining whether hand therapy should be conducted after collagenase treatment.Trial registrationThis study has been registered at ClinicalTrials.gov as NCT03580213 (April 5, 2018).

Dataset Information

Additional Treatment after Collagenase Injections and Needle Fasciotomy for Dupuytren's Disease: A Retrospective Cohort Study.

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Additional Treatment after Collagenase Injections and Needle Fasciotomy for Dupuytren's Disease: A Retrospective Cohort Study.

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