Collagenase Injection vs Percutaneous Needle Aponeurotomy for Dupuytren's Disease

Phase 4

• Conditions: Dupuytren Contracture; Dupuytren's Disease of Finger
• Interventions: Procedure: Percutaneous Needle Aponeurotomy; Drug: XIAFLEX

• Registration Number: NCT03000114
• Lead Sponsor: University of Calgary

Brief Summary

Dupuytren's disease is a non-curative, progressive disorder leading to function-impairing deformities of the hand. Although numerous treatments exist, the most common and widely accepted therapy is removal of diseased fascia. Surgery is limited by prolonged recovery time, and many patients require multiple surgeries throughout their life as the disease progresses, with repeat surgeries increasing the risk of complications.

Long recovery times and need for repeat surgeries has renewed interest in minimally invasive treatments for Dupuytren's disease. Percutaneous needle aponeurotomy (PNA) allows for rapid improvement in finger extension with minimal recovery time. The FDA approved collagenase clostridium histolyticum injection for Dupuytren's disease in 2010, which also allows for rapid increase in finger extension, also with minimal recovery time. Currently there is only one small study comparing PNA and collagenase injection (CI) that suggests similar outcomes in both treatments. Both treatments are minimally invasive, requiring minimal time off work and post-procedure pain. The main barrier to widespread adoption of CI is cost, particularly in patients with multiple areas of disease requiring treatment. The project proposed will compare these two methods for treating Dupuytren's disease.

Approximately 334 participants will be recruited from patients referred for treatment to hand surgeons trained in CI and PNA at two Calgary, AB hospitals. Need for treatment will be determined in the usual fashion, and the option for entry into the study will be proposed to patients meeting inclusion/exclusion criteria. Participants will be randomized into either the PNA or CI treatment group. The surgeon will not be blinded to the procedure group; however, the therapist measuring outcomes will be, and the study participants will need to not divulge to the therapists which group they are in.

Both procedures are performed under local freezing, and range from 5-20minutes. PNA involves the surgeon freezing the skin over the Dupuytren's cord, then using a small gauge needle inserted under the skin to cut the cord. This is repeated up the length of the cord to weaken it, allowing the surgeon to extend the finger and rupture the cord. CI involves the injection of collagenase (Xiaflex®), directly into the Dupuytren's cord. The patient then returns to see the surgeon within one week, has freezing placed in the hand, and the affected digit is extended to rupture the already weakened cord.

The patient will be required to present to the hand therapist team for measurements of joint angles before and after the assigned treatment is performed. In order to measure treatment efficacy, study participants will be required to return for measurements of treated joints every 6 months. Lastly, participants will need to inform the performing surgeon or therapist, at follow-up visits of any complications they experience.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Status Verified: 2016-12
• Study First Submitted: 2016-12-17
• Study First Submitted QC: 2016-12-20
• Last Update Submitted: 2016-12-20
• Study First Posted: 2016-12-21
• Last Update Posted: 2016-12-21
• Primary Completion: 2021-01
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 334

Inclusion Criteria

• Patients requiring treatment for functionally limiting Dupuytren's disease involving the MCP and PIP joints, defined as MCP joint contracture 20-100 degrees, PIP joint contracture 20-80 degrees and positive table top test. Patients must be over 18 years of age to enroll in the study.

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Exclusion Criteria

• Patients who have had previous interventions of contracture presenting for treatment, in an effort to compare similar disease state and risk with each procedure.
• Disease involving DIP joint or thumb, as collagenase has not been approved for use in the thumb or DIP joints.
• Pregnant or nursing, although there is data indicating no detection of collagenase in patient serum following injection for Dupuytren's contractures, there is no data exploring the effects of collagenase on a fetus or infant.
• Anticoagulation therapy other than ASA (held 7 days prior to procedure), which is a recommendation by the manufacture of collagenase used in this study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Percutaneous Needle Aponeurotomy	Percutaneous Needle Aponeurotomy	Percutaneous Needle Aponeurotomy (PNA) involves the surgeon anaesthetizing the skin over the Dupuytren's cord, then using a small gauge needle inserted percutaneously, cutting the cord with the sharp edge of the needle using a sweeping motion. This is repeated up the length of the cord to weaken it, allowing an extension force to be applied over the finger to rupture the cord.
Collagenase Injection	XIAFLEX	Collagenase Injection (CI) involves the injection of collagenase clostridium histolyticum (0.58 mg), directly into the Dupuytren's cord. The patient then returns to see the surgeon within one week, has local anaesthetic is administered, and an extension force is applied to the affected digit to rupture the already weakened cord.

Primary Outcome Measures

Name	Time	Method
Contracture Recurrence	6 months - 5 years	Recurrence defined by an increase in joint contracture of at least 30 degrees in presence of palpable cord, or the patient underwent repeat intervention to correct new/worsening contracture in the treated joint.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction	Intervention to 5 years post-intervention	Survey
Complications	Intervention to 5 years post-intervention	Patient to Report

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada