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

NCT ID: NCT00261209

Last Updated: 2016-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Adhesion of Flexor Tendon of Hand

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Collagenase Injection

Injection of collagenase into adhesion restricting tendon gliding

Group Type EXPERIMENTAL

Collagenase

Intervention Type DRUG

Collagenase injection into adhesion restricting tendon gliding

Collagenase injection

Intervention Type DRUG

injection of collagenase into adhesion restricting tendon gliding

Interventions

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Collagenase

Collagenase injection into adhesion restricting tendon gliding

Intervention Type DRUG

Collagenase injection

injection of collagenase into adhesion restricting tendon gliding

Intervention Type DRUG

Other Intervention Names

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Collagenase Clostridium Histolyticum Collagenase Clostridium Histolyticum

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stony Brook University

OTHER

Sponsor Role lead

Responsible Party

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Marie A. Badalamente

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marie A Badalamente, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. Orthopaedics, SUNY@Stony Brook, NY 11794

Edward Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. Orthopaedics, SUNY@Stony Brook, NY 11794

Locations

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Dept. Orthopaedics, SUNY@Stony Brook

Stony Brook, New York, United States

Site Status

Countries

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United States

Other Identifiers

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Tendon 101

Identifier Type: -

Identifier Source: org_study_id

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