Clinical trial NCT03406338: Fasciectomy vs Collagenase Injection in Recurrent Dupuytren Disease
Official title: Surgical Fasciectomy Versus Collagenase Injection in Treating Recurrent Dupuytren Disease: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Dupuytren Disease of Finger
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized parallel Group, ratio 1:1.
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial will compare the outcome of surgery (fasciectomy) with that of local injection of Collagenase Clostridium Histolyticum in patients with recurrent finger joint contracture after previous treatment with Surgery, collagenase injection or needle fasciotomy. Half of the participants will be treated with surgery while the other half will receive collagenase injection.

Detailed description: No definitive cure for Dupuytren disease (DD) currently exists and recurrence of finger contractures after treatment is common. Surgical fasciectomy is considered the standard treatment method for patients with recurrence. However, the procedure is associated with a high incidence of complications. Injection of Collagenase Clostridium Histolyticum into Dypuytren cords causing the contracture is a non-surgical treatment for DD and has been shown to be a safe and effective method. Most studies regarding collagenase injection have involved first-time treatment. Efficacy of collagenase injection in patients with recurrent DD, beyond the immediate effect, has not yet been determined. This randomized trial will compare the outcome of surgical fasciectomy and collagenase injection in treating patients with finger joints contracture due to recurrent DD. The study is a single-center randomized controlled trial. Patients referred to an orthopedic department are screened for eligibility. The inclusion criteria are recurrence of DD in one or more fingers after previous treatment with fasciectomy, collagenase injection or needle fasciotomy, a passive extension deficit ≥30 degrees in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joint in a previously treated finger, and a palpable cord believed to cause the recurrent contracture. A total of 56 patients will be randomized (computer-generated randomization list, stratified according to type of previous treatment and affected finger), to either surgical fasciectomy or collagenase injection. A blinded hand therapist will measure range of motion (including active and passive extension deficit) at baseline and 3 months, 12 months, 24 months and 60 months after treatment. The primary outcomes are the total active extension deficit (MCP plus PIP) at 3 months and the proportion of patients with contracture worsening ≥20 degrees in the treated finger joint at 2 years compared to 3 months. The secondary outcomes include total passive extension deficit, the 11-item disabilities of the arm, shoulder and hand (QuickDASH) score, EuroQol 5-dimensions (EQ-5D) index, cold intolerance symptom severity score, palmar pain score, pain visual analog scale (VAS) score, satisfaction VAS score, adverse events and costs.

Eligibility criteria: Inclusion Criteria:

* Seeking treatment for recurrence of Dupuytren´s contracture in at least one finger.
* Passive extension deficit of 30 degrees or greater in the metacarpophalangeal and/or proximal interphalangeal joint in a finger previously treated with surgical fasciectomy, collagenase injections, or needle fasciotomy.
* Palpable cord in the palm and/or affected finger causing the recurrent contracture.
* No Surgery, collagenase injection or needle fasciotomy in the finger with recurrent contracture in the past 12 months.

Exclusion Criteria:

* Medical comorbidities that constitute a contraindication for surgical fasciectomy or collagenase injection.
* Signs of nerve or vascular injury in the affected finger.
* Osteoarthritis in the metacarpophalangeal and/or proximal interphalangeal joint joint in the affected finger
* Complications after the previous treatment, such as infection or complex regional pain syndrome (CRPS).
* Previous trauma or other surgery involving the affected finger.
* More than 2 previous surgeries, collagenase injections or needle fasciotomies in the affected finger.
* Examining surgeon deems further fasciectomy inappropriate or potentially associated with very high complication risk, for example in severe contracture and/or severe scarring after the previous surgeries and considers salvage procedures (such as amputation) as the more appropriate treatment.
* Patient refusal to participate

Primary outcomes:
measure: Total active extension deficit (metacarpophalangeal plus proximal interphalangeal joints)
timeFrame: Change from baseline to 3 months
measure: Proportion of patients with worsening in total active extension deficit ≥20 degrees
timeFrame: 24 months compared to 3 months
Secondary outcomes:
measure: 11-item disabilities of the arm, shoulder and hand (QuickDASH) score
timeFrame: Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months
measure: EuroQoL 5-dimensions (EQ-5D) Index
timeFrame: Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months
measure: Pain score
timeFrame: Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months
measure: Satisfaction score
timeFrame: 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months
measure: Adverse events
timeFrame: Anytime during 24 months after treatment
measure: Costs
timeFrame: From baseline through 24 months
measure: Total active motion
timeFrame: Change from baseline to 3 months, 12 months, 24 months and 60 months
measure: Total active extension deficit (metacarpophalangeal plus proximal interphalangeal joints)
timeFrame: Change from baseline to 12 months, 24 months and 60 months
measure: Proportion of patients with worsening in total active extension deficit ≥20 degrees
timeFrame: 60 months compared to 3 months
measure: Palmar pain score
timeFrame: Change over time from baseline to 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months.
measure: Cold intolerance symptom severity score
timeFrame: Change from baseline to 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months.
measure: Total passive extension deficit (metacarpophalangeal plus proximal interphalangeal joints)
timeFrame: Change from baseline to 24 months and 60 months
Other outcomes:
Locations:
city: Hässleholm
country: Sweden
facility: Department of Orthopedics Hässleholm-Kristianstad
Study officials:
affiliation: Lund University
name: Isam Atroshi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nordenskjold J, Lauritzson A, Walden M, Kopylov P, Atroshi I. Surgical fasciectomy versus collagenase injection in treating recurrent Dupuytren disease: study protocol of a randomised controlled trial. BMJ Open. 2019 Feb 25;9(2):e024424. doi: 10.1136/bmjopen-2018-024424.