Dataset Information

Patient-Reported Outcome in Dupuytren's Disease Treated With Fasciectomy, Collagenase or Needle Fasciotomy: A Swedish Registry Study.

ABSTRACT:

Purpose

This registry study compares the patient-reported outcomes of 3 treatments for Dupuytren´s disease: open fasciectomy (OF), collagenase injection (CCH) and percutaneous needle fasciotomy (PNF).

Methods

From the Swedish national quality registry for hand surgery (HAKIR) we included 2,585 procedures (in 2,414 patients): 1,200 treatments were OF, 918 CCH, and 467 PNF. The choice between CCH and PNF varied mainly because of regional differences in reimbursement of CCH. We report the results of the validated patient-reported outcome instrument HQ-8. HQ-8 evaluates symptoms in the treated hand and is issued before treatment, 3 and 12 months after treatment and is used for all patients in HAKIR.

Results

At 3-month follow-up, patients treated with CCH or PNF experienced less stiffness, weakness, numbness, tingling and sensitivity to cold. At 12 months, the differences among the 3 treatments were smaller, but CCH patients experienced less stiffness and weakness compared to PNF-treated patients.

Conclusions

Most randomized controlled trials have not shown significant differences in recurrence rates or patient-reported outcomes between CCH and PNF, but the number of patients has been limited and no randomized controlled trials have included all 3 treatments. In the present study, we compared registry data on patient-reported outcomes for OF, CCH, and PNF in a real-life clinical setting. Our results confirm that the noninvasive treatments (CCH and PNF) cause less disability than OF and indicate a possible advantage of CCH compared to PNF regarding stiffness and weakness at 1 year after treatment based on patient-reported outcomes. Patient-reported residual symptoms are important to consider when informing patients and selecting treatment for Dupuytren´s disease.

Type of study/level of evidence

Observational registry study III.

SUBMITTER: Harryson M

PROVIDER: S-EPMC10721495 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Patient-Reported Outcome in Dupuytren's Disease Treated With Fasciectomy, Collagenase or Needle Fasciotomy: A Swedish Registry Study.

Harryson Madeleine M Eklund Martin M Arner Marianne M Wilbrand Stephan S

Journal of hand surgery global online 20230719 6

<h4>Purpose</h4>This registry study compares the patient-reported outcomes of 3 treatments for Dupuytren´s disease: open fasciectomy (OF), collagenase injection (CCH) and percutaneous needle fasciotomy (PNF).<h4>Methods</h4>From the Swedish national quality registry for hand surgery (HAKIR) we included 2,585 procedures (in 2,414 patients): 1,200 treatments were OF, 918 CCH, and 467 PNF. The choice between CCH and PNF varied mainly because of regional differences in reimbursement of CCH. We repor ...[more]

PMID: 38106934

Similar Datasets

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: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: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.

Dataset Information

Patient-Reported Outcome in Dupuytren's Disease Treated With Fasciectomy, Collagenase or Needle Fasciotomy: A Swedish Registry Study.

Purpose

Methods

Results

Conclusions

Type of study/level of evidence

Publications

Patient-Reported Outcome in Dupuytren's Disease Treated With Fasciectomy, Collagenase or Needle Fasciotomy: A Swedish Registry Study.

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