Collagenase Injection vs Percutaneous Needle Aponeurotomy for Dupuytren's Disease

December 20, 2016 updated by: Justin Yeung, University of Calgary

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

334

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: Percutaneous Needle Aponeurotomy
Other Names:
  • Percutaneous Needle Fasciotomy
Active Comparator: Collagenase Injection
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
Other Names:
  • collagenase clostridium histolyticum

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Investigators

  • Principal Investigator: Justin Yeung, MD, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

December 17, 2016

First Submitted That Met QC Criteria

December 20, 2016

First Posted (Estimate)

December 21, 2016

Study Record Updates

Last Update Posted (Estimate)

December 21, 2016

Last Update Submitted That Met QC Criteria

December 20, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB15-2463

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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