Fasciectomy vs Collagenase Injection in Recurrent Dupuytren Disease

Dupuytren Disease of Finger Clinical Trial

Official title:

Surgical Fasciectomy Versus Collagenase Injection in Treating Recurrent Dupuytren Disease: a Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03406338
• Other study ID #: Hlm_DC
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: March 20, 2018
• Est. completion date: September 2027

Study information

• Verified date: November 2023
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 2027
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dupuytren Contracture
• Dupuytren Disease of Finger

Intervention

Procedure:
• Fasciectomy
Surgical excision of Dupuytren cords causing finger joint contractures. Surgery done under regional or general anesthesia. Additional procedures (such as capsulotomy or skin graft) done if surgeon deemed necessary.

Drug:
• Collagenase Clostridium Histolyticum
Injection of Collagenase into the Dupuytren cord after local anesthesia (nerve block) followed 24-48 hours later by finger manipulation after local anesthesia

Locations

Country	Name	City	State
Sweden	Department of Orthopedics Hässleholm-Kristianstad	Hässleholm

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total active extension deficit (metacarpophalangeal plus proximal interphalangeal joints)	Extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit)	Change from baseline to 3 months
Primary	Proportion of patients with worsening in total active extension deficit =20 degrees	Extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit)	24 months compared to 3 months
Secondary	11-item disabilities of the arm, shoulder and hand (QuickDASH) score	A patient-reported outcome measure of activity limitations related to upper extremity disorders, with total score range from 0 (best) to 100 (worst)	Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months
Secondary	EuroQoL 5-dimensions (EQ-5D) Index	Health-status and quality-of-life patient-reported measure, consists of 5 items, a single weighted score, the EQ-5D index, is calculated from the 5 dimensions, ranging from -0.594 (worst) to 1.0 (perfect health)	Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months
Secondary	Pain score	Visual analog scale of pain in the treated hand, score range from 0 (best) to 100 (worst)	Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months
Secondary	Satisfaction score	Visual analog scale of patient satisfaction with treatment outcome, score range from 0 (best) to 100 (worst)	3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months
Secondary	Adverse events	All observed and reported adverse events will be recorded on a standard form. Serious adverse events include nerve, artery or tendon damage, deep infection, complex regional pain syndrome and any complications requiring surgery or hospital admission.	Anytime during 24 months after treatment
Secondary	Costs	Total treatment cost, direct (medications, surgery, materials, visits etc) and indirect (sick leave related to the treatment)	From baseline through 24 months
Secondary	Total active motion	Sum of active range of motion of metacarpophalangeal, proximal intephalangeal and distal interphalangeal joints of the treated finger	Change from baseline to 3 months, 12 months, 24 months and 60 months
Secondary	Total active extension deficit (metacarpophalangeal plus proximal interphalangeal joints)	Active extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit)	Change from baseline to 12 months, 24 months and 60 months
Secondary	Proportion of patients with worsening in total active extension deficit =20 degrees	Extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit)	60 months compared to 3 months
Secondary	Palmar pain score	2-item scale inquiring about pain in the palm and related activity limitations, total score range 0 (best) to 100 (worst)	Change over time from baseline to 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months.
Secondary	Cold intolerance symptom severity score	6-item scale inquiring about symptoms of cold intolerance, total score range 4 (best) to 100 (worst)	Change from baseline to 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months.
Secondary	Total passive extension deficit (metacarpophalangeal plus proximal interphalangeal joints)	Passive extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit)	Change from baseline to 24 months and 60 months