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

This study has been completed.

First Received: November 30, 2005 Last Updated: March 28, 2009 History of Changes

Sponsor:	Stony Brook University
Collaborator:	Biospecifics Technologies Corp.
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	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Stony Brook University:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	5
Study Start Date:	January 2005
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

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

Biospecifics Technologies Corp.

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

Study ID Numbers:	Tendon 101
Study First Received:	November 30, 2005
Last Updated:	March 28, 2009
ClinicalTrials.gov Identifier:	NCT00261209 History of Changes
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:

Pathologic Processes
Adhesions

ClinicalTrials.gov processed this record on February 08, 2010