Collagenase and Needle Aponeurotomy: Single Modality Versus Combination Treatment for Dupuytren's Disease

NCT01776892 | Withdrawn Phase 3

• 1 other identifier: Dupuytren's 001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Dupuytren's disease results in deformity of the hand and this can lead to trouble with daily activities. Treatment traditionally involves cutting out diseased tissue, however this can cause damage to important structures in the hand and results in large scars. Needle aponeurotomy and collagenase injections are newer treatments that are thought to be safer. These treatments allow quicker return to function. One drawback is that Dupuytren's deformity may return more quickly than when all diseased tissue is surgically cut out. This research study is designed to compare the effectiveness of needle aponeurotomy and collagenase injection for Dupuytren's disease. This study will determine which procedure gives the best results- either needle aponeurotomy, collagenase injection, or both procedures in combination. Participants will be evaluated to see how they do in the long term.

Conditions

Dupuytren Contracture

Keywords

Collagenase; Needle aponeurotomy

Outcome Measures

Primary Outcomes (1)

• Degree of joint contracture post treatment

  The degree of the participant's Dupuytren's disease joint contracture after treatment will be measured by a physical therapist at each of the participant's follow up appointments.

  5 years post treatment

Secondary Outcomes (1)

• Change in joint range of motion

  Baseline and 5 years post treatment

Study Arms (3)

Collagenase and needle aponeurotomy

EXPERIMENTAL

Participants in this arm of the study will be treated once with needle aponeurotomy and up to 3 times at 4 week intervals with collagenase injection. Affected Dupuytren's cords will be treated with 1-3 collagenase clostridium histolyticum injections at 4 week intervals, based on clinical response of the contracture. Cords will be treated until motion of the joint is within 0-5 degrees of normal, for up to 3 total injections. Percutaneous needle aponeurotomy will be performed using an 18 gauge needle. The needle is inserted through the skin into the Dupuytren's cord. The needle is moved very slowly through the cord until complete rupture of the cord is obtained.

Drug: Collegenase injection; Procedure: Needle aponeurotomy

Needle aponeurotomy

ACTIVE COMPARATOR

Percutaneous needle aponeurotomy will be performed using an 18 gauge needle. The needle is inserted through the skin into the Dupuytren's cord. The needle is moved very slowly through the cord until complete rupture of the cord is obtained. Participant feedback is obtained throughout the procedure to prevent digital nerve or flexor tendon injury. Participants are asked to report Tinel's sign which indicates that the needle is in close proximity to the digital nerve and to report pain with needle advancement which indicates proximity to the flexor tendon.

Procedure: Needle aponeurotomy

Collagenase injection

ACTIVE COMPARATOR

Collagenase clostridium histolyticum will be used to treat participants in this arm of the study. Affected cords will be treated with 1-3 collagenase injections at 4 week intervals, based on clinical response of the contracture. Cords will be treated until motion of the joint is within 0-5 degrees of normal, for up to 3 total injections. Metacarpophalangeal cords will be injected with 0.58mg (10 000 units) of collagenase in 0.25ml of sterile diluent. Proximal interphalangeal cords will be injected with 0.58mg (10 000 units) of collagenase in 0.20ml of sterile diluent.

Drug: Collegenase injection

Interventions

Collegenase injection DRUG

Collagenase clostridium histolyticum will be used to treat participants in this arm of the study. Affected cords will be treated with 1-3 collagenase injections at 4 week intervals, based on clinical response of the contracture. Cords will be treated until motion of the joint is within 0-5 degrees of normal, for up to 3 total injections. Metacarpophalangeal cords will be injected with 0.58mg (10 000 units) of collagenase in 0.25ml of sterile diluent. Proximal interphalangeal cords will be injected with 0.58mg (10 000 units) of collagenase in 0.20ml of sterile diluent.

Also known as: Trade name: Xiaflex.

Collagenase and needle aponeurotomy; Collagenase injection

Needle aponeurotomy PROCEDURE

Percutaneous needle aponeurotomy will be performed using an 18 gauge needle. The needle is inserted through the skin into the Dupuytren's cord. The needle is moved very slowly through the cord until complete rupture of the cord is obtained.

Collagenase and needle aponeurotomy; Needle aponeurotomy

Eligibility Criteria

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

You may qualify if:

• years of age or older
• Metacarpophalangeal joint contracture between 20-100 degrees OR proximal interphalangeal joint contracture between 20-80 degrees
• Positive table top test, defined as the inability to simultaneously place the affected finger and palm flat on a table

You may not qualify if:

• Use of an anticoagulant within 7 days before the beginning of the study, excluding aspirin
• Bleeding disorder
• Recent stroke
• Allergy to collagenase
• A chronic muscular, neurologic, or neuromuscular disorder affecting the hands
• Previous treatment of the affected joint within 90 days before the beginning of the study
• Use of a tetracycline derivative within 14 days before the beginning of the study
• Pregnancy
• Breast feeding
• Premenopausal woman, not using contraception

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Related Publications (5)

• Badalamente MA, Hurst LC. Enzyme injection as nonsurgical treatment of Dupuytren's disease. J Hand Surg Am. 2000 Jul;25(4):629-36. doi: 10.1053/jhsu.2000.6918.

  PMID: 10913202 BACKGROUND

• Badalamente MA, Hurst LC, Hentz VR. Collagen as a clinical target: nonoperative treatment of Dupuytren's disease. J Hand Surg Am. 2002 Sep;27(5):788-98. doi: 10.1053/jhsu.2002.35299.

  PMID: 12239666 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

• 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

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

Study Officials

• Michael Morhart, MD MSc

  Division of Plastic Surgery, Department of Surgery, University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2013
• First Posted: January 28, 2013
• Study Start: May 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 8, 2014

Record last verified: 2014-04

Locations

CA (1)