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Collagenase in the Treatment of Zone II Flexor Tendon Adhesions in the Hand

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marie A. Badalamente, Stony Brook University
ClinicalTrials.gov Identifier:
NCT00261209
First received: November 30, 2005
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to dissolve flexor tendon adhesions associated with failed tendon repair surgery.


Condition Intervention Phase
Adhesion of Flexor Tendon of Hand
Drug: Collagenase
Drug: Collagenase injection
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Collagenase Injection Therapy for Treatment of Zone II Flexor Tendon Adhesions in the Hand

Resource links provided by NLM:


Further study details as provided by Stony Brook University:

Primary Outcome Measures:
  • Restoration of PIP and DIP joint motion. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hand Grip strength (kg) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 3
Study Start Date: January 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Collagenase Injection
Injection of collagenase into adhesion restricting tendon gliding
Drug: Collagenase
Collagenase injection into adhesion restricting tendon gliding
Other Name: Collagenase Clostridium Histolyticum
Drug: Collagenase injection
injection of collagenase into adhesion restricting tendon gliding
Other Name: Collagenase Clostridium Histolyticum

Detailed Description:

In an open label study, collagenase injection therapy was investigated in 3 subjects for it's ability to lyse flexor tendon adhesions in zone II of the hand.

Results indicate that two of three subjects had improved range of finger motion at the PIP and DIP joints. This may obviate the need for patients to have tenolysis hand surgery to correct the finger flexion contracture of the PIP and DIP joints. Detailed controlled studies remain to be done.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • zone II flexor tendon adhesion of at least one finger

Exclusion Criteria:

  • any chronic, serious or uncontrolled medical condition
  • inability to conform to study visits (12-15 per year)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00261209

Locations
United States, New York
Dept. Orthopaedics, SUNY@Stony Brook
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
Stony Brook University
Investigators
Principal Investigator: Marie A Badalamente, PhD Dept. Orthopaedics, SUNY@Stony Brook, NY 11794
Principal Investigator: Edward Wang, MD Dept. Orthopaedics, SUNY@Stony Brook, NY 11794
  More Information

No publications provided

Responsible Party: Marie A. Badalamente, Professor, Stony Brook University
ClinicalTrials.gov Identifier: NCT00261209     History of Changes
Other Study ID Numbers: Tendon 101
Study First Received: November 30, 2005
Last Updated: December 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Stony Brook University:
Flexor Tendon Adhesions
Zone II of the Hand

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014