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

April 20, 2016 updated by: Marie A. Badalamente, Stony Brook University

Study of Collagenase Injection Therapy for Treatment of Zone II Flexor Tendon Adhesions in the Hand

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Locations

  • United States
    • New York
      • Stony Brook, New York, United States, 11794
        • Dept. Orthopaedics, SUNY@Stony Brook

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Collagenase Injection
Injection of collagenase into adhesion restricting tendon gliding
Drug: Collagenase
Collagenase injection into adhesion restricting tendon gliding
Other Names:
  • Collagenase Clostridium Histolyticum
Drug: Collagenase injection
injection of collagenase into adhesion restricting tendon gliding
Other Names:
  • Collagenase Clostridium Histolyticum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Restoration of PIP and DIP joint motion.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Hand Grip strength (kg)
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Stony Brook University

Investigators

  • Principal Investigator: Edward Wang, MD, Dept. Orthopaedics, SUNY@Stony Brook, NY 11794

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, 2005

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

November 30, 2005

First Submitted That Met QC Criteria

November 30, 2005

First Posted (Estimate)

December 2, 2005

Study Record Updates

Last Update Posted (Estimate)

April 21, 2016

Last Update Submitted That Met QC Criteria

April 20, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tendon 101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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