Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT03000114
Study type Interventional
Source University of Calgary
Contact Justin Yeung, MD
Phone 403-800-9157
Email [email protected]
Status Recruiting
Phase Phase 4
Start date January 2016
Completion date January 2021

See also
  Status Clinical Trial Phase
Recruiting NCT03155854 - The Effects of Prophylactic Limited Palmar Fasciectomy on Surgical Outcomes and Scarring N/A
Active, not recruiting NCT03192020 - Trial Comparing Treatment Strategies in Dupuytren's Contracture Phase 4
Active, not recruiting NCT02647619 - Dupuytren´s Disease Study. Primary Disease, MCP Joint, Xiapex, PNF Phase 4
Recruiting NCT01184586 - Dupuytren's Disease and Extracorporeal Shockwave Therapy (DupuyShock-2010) Phase 2
Recruiting NCT04122313 - Post-contracture Release Radiation for Dupuytren's Disease
Withdrawn NCT01776892 - Collagenase and Needle Aponeurotomy: Single Modality Versus Combination Treatment for Dupuytren's Disease Phase 3
Active, not recruiting NCT01923103 - Natural Disease Progress of Dupuytren Disease
Active, not recruiting NCT02983162 - Is wGRS Associated With DD Recurrence?
Enrolling by invitation NCT03982719 - Comparing the Effectiveness of Two Post-fasciectomy Rehabilitation Protocols in Patients With Dupuytren's Disease N/A
Not yet recruiting NCT04907812 - The Role of Tranexamic Acid in Reducing Post Operative Hand Edema After Hand and Wrist Surgery Phase 4
Not yet recruiting NCT04874870 - Effectiveness of Splinting After Collagenase Injection Phase 3
Active, not recruiting NCT03031080 - BOND Study: the Benefit Of Night Splinting in Dupuytrens' N/A
Active, not recruiting NCT03407820 - Different Sutures in Hand Surgery N/A
Completed NCT03331926 - Collagenase is a Common Treatment of MCP and PIP Joint Contractures in Dupuytrens Disease
Recruiting NCT03741764 - Treatment of Dupuytren's Disease With Minimal Invasive Surgery and VIVOSORB® Resorbable Implant Device N/A
Completed NCT01876498 - Registry of Patient With M. Dupuytren and Validation of the Brief MHQ N/A
Completed NCT03868449 - Question Prompt List for Common Hand Conditions N/A
Completed NCT03573765 - Epidemiology and Outcomes of Upper Limb Surgery: Analysis of Routine Data
Completed NCT03111186 - Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Hand Surgery Phase 2