Collagenase Injection vs Percutaneous Needle Aponeurotomy for Dupuytren's Disease

NCT03000114 | Unknown Phase 4

• 1 other identifier: REB15-2463
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

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.

Conditions

Dupuytren Contracture; Dupuytren's Disease of Finger

Keywords

Collagenase injection; percutaneous needle aponeurotomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient Satisfaction

  Intervention to 5 years post-intervention

• Complications

  Intervention to 5 years post-intervention

Study Arms (2)

Percutaneous Needle Aponeurotomy

ACTIVE COMPARATOR

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

Collagenase Injection

ACTIVE COMPARATOR

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

Interventions

Percutaneous Needle Aponeurotomy PROCEDURE

Also known as: Percutaneous Needle Fasciotomy

Percutaneous Needle Aponeurotomy

XIAFLEX DRUG

Also known as: collagenase clostridium histolyticum

Collagenase Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N2T9, Canada

RECRUITING

Related Publications (11)

• Desai SS, Hentz VR. The treatment of Dupuytren disease. J Hand Surg Am. 2011 May;36(5):936-42. doi: 10.1016/j.jhsa.2011.03.002.

  PMID: 21527148 BACKGROUND

• Lermusiaux JL, Debeyre N. Le traitement médical de la maladie de Dupuytren. In: de Sèze S, Ryckewaert A, Kahn MF, Guérin CI. L'actualité rhumatologique 1979. Paris: Expansion Scientifique Française, 1980:338 -343.

  BACKGROUND

• Hurst LC, Badalamente MA, Hentz VR, Hotchkiss RN, Kaplan FT, Meals RA, Smith TM, Rodzvilla J; CORD I Study Group. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med. 2009 Sep 3;361(10):968-79. doi: 10.1056/NEJMoa0810866.

  PMID: 19726771 BACKGROUND

• Gilpin D, Coleman S, Hall S, Houston A, Karrasch J, Jones N. Injectable collagenase Clostridium histolyticum: a new nonsurgical treatment for Dupuytren's disease. J Hand Surg Am. 2010 Dec;35(12):2027-38.e1. doi: 10.1016/j.jhsa.2010.08.007.

  PMID: 21134613 BACKGROUND

• Nydick JA, Olliff BW, Garcia MJ, Hess AV, Stone JD. A comparison of percutaneous needle fasciotomy and collagenase injection for dupuytren disease. J Hand Surg Am. 2013 Dec;38(12):2377-80. doi: 10.1016/j.jhsa.2013.08.096. Epub 2013 Sep 20.

  PMID: 24060510 BACKGROUND

• Chen NC, Shauver MJ, Chung KC. Cost-effectiveness of open partial fasciectomy, needle aponeurotomy, and collagenase injection for dupuytren contracture. J Hand Surg Am. 2011 Nov;36(11):1826-1834.e32. doi: 10.1016/j.jhsa.2011.08.004. Epub 2011 Oct 5.

  PMID: 21981831 BACKGROUND

• Smith AC. Diagnosis and indications for surgical treatment. Hand Clin. 1991 Nov;7(4):635-42; discussion 643.

  PMID: 1769986 BACKGROUND

• Peimer CA, Blazar P, Coleman S, Kaplan FT, Smith T, Lindau T. Dupuytren Contracture Recurrence Following Treatment With Collagenase Clostridium histolyticum (CORDLESS [Collagenase Option for Reduction of Dupuytren Long-Term Evaluation of Safety Study]): 5-Year Data. J Hand Surg Am. 2015 Aug;40(8):1597-605. doi: 10.1016/j.jhsa.2015.04.036. Epub 2015 Jun 18.

  PMID: 26096221 BACKGROUND

• van Rijssen AL, Werker PM. Percutaneous needle fasciotomy in dupuytren's disease. J Hand Surg Br. 2006 Oct;31(5):498-501. doi: 10.1016/j.jhsb.2006.03.174. Epub 2006 Jun 12.

  PMID: 16766101 BACKGROUND

• Zhang AY, Curtin CM, Hentz VR. Flexor tendon rupture after collagenase injection for Dupuytren contracture: case report. J Hand Surg Am. 2011 Aug;36(8):1323-5. doi: 10.1016/j.jhsa.2011.05.016. Epub 2011 Jun 25.

  PMID: 21705158 BACKGROUND

• van Rijssen AL, Ter Linden H, Werker PMN. Five-year results of a randomized clinical trial on treatment in Dupuytren's disease: percutaneous needle fasciotomy versus limited fasciectomy. Plast Reconstr Surg. 2012 Feb;129(2):469-477. doi: 10.1097/PRS.0b013e31823aea95.

  PMID: 21987045 BACKGROUND

MeSH Terms

Conditions

Dupuytren Contracture

Interventions

Microbial Collagenase

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Contracture; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Collagenases; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Study Officials

• Justin Yeung, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin Yeung, MD

CONTACT

403-800-9157; Justin.Yeung2@albertahealthservices.ca

Valerie Hurdle, MD

CONTACT

4038161345; vhurdle@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 17, 2016
• First Posted: December 21, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: December 21, 2016

Record last verified: 2016-12

Locations

CA (1)