Collagenase in the Treatment of Zone II Flexor Tendon Adhesions in the Hand - Full Text View

Sponsor:	Stony Brook University
Information provided by:	Stony Brook University
ClinicalTrials.gov Identifier:	NCT00261209

Purpose

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

Condition	Intervention	Phase
Hand Zone II Flexor Tendon Adhesions	Drug: Collagenase Drug: Collagenase injection	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized 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:

MedlinePlus related topics: Adhesions

Drug Information available for: Collagenase

U.S. FDA Resources

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 ]

Estimated Enrollment:	10
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 Drug: Collagenase injection injection of collagenase into adhesion restricting tendon gliding

Detailed Description:

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

Results may obviate the need for patients to have tenolysis hand surgery to correct the finger flexion contrature of the PIP and DIP joints.

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

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, State University of NY @ Stony Brook
ClinicalTrials.gov Identifier:	NCT00261209 History of Changes
Other Study ID Numbers:	Tendon 101
Study First Received:	November 30, 2005
Last Updated:	August 16, 2011
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 February 09, 2012