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

Information source: Stony Brook University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Adhesion of Flexor Tendon of Hand

Intervention: Collagenase (Drug); Collagenase injection (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Stony Brook University

Official(s) and/or principal investigator(s):
Marie A Badalamente, PhD, Principal Investigator, Affiliation: Dept. Orthopaedics, SUNY@Stony Brook, NY 11794
Edward Wang, MD, Principal Investigator, Affiliation: Dept. Orthopaedics, SUNY@Stony Brook, NY 11794

Summary

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

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Restoration of PIP and DIP joint motion.

Secondary outcome: Hand Grip strength (kg)

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

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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)

Locations and Contacts

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

Starting date: January 2005
Last updated: December 11, 2012

Page last updated: August 23, 2015

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