Collagenase Injection vs Percutaneous Needle Aponeurotomy for Dupuytren's Disease

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Collagenase Injection and Percutaneous Needle Aponeurotomy for Treatment of Dupuytren's Disease

Conditions
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Dupuytren Contracture, Dupuytren's Disease of Finger

Intervention / Treatment
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* Procedure: Percutaneous Needle Aponeurotomy
* Drug: XIAFLEX


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Percutaneous Needle Aponeurotomy<br>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. | Procedure: Percutaneous Needle Aponeurotomy<br> <br> * Other names: Percutaneous Needle Fasciotomy;|
| Active Comparator: Collagenase Injection<br>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. | Drug: XIAFLEX<br> <br> * Other names: collagenase clostridium histolyticum;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contracture Recurrence | 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. | 6 months - 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | Survey | Intervention to 5 years post-intervention | 
| Complications | Patient to Report | Intervention to 5 years post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Collagenase injection, percutaneous needle aponeurotomy