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

Primary Purpose

Adhesion of Flexor Tendon of Hand

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Collagenase

Collagenase injection

About this trial

This is an interventional treatment trial for Adhesion of Flexor Tendon of Hand focused on measuring Flexor Tendon Adhesions, Zone II of the Hand

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Dept. Orthopaedics, SUNY@Stony Brook

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Collagenase Injection

Arm Description

Injection of collagenase into adhesion restricting tendon gliding

Outcomes

Primary Outcome Measures

Restoration of PIP and DIP joint motion.

Secondary Outcome Measures

Hand Grip strength (kg)

Full Information

NCT ID

NCT00261209

First Posted

November 30, 2005

Last Updated

April 20, 2016

Sponsor

Stony Brook University

1. Study Identification

Unique Protocol Identification Number

NCT00261209

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stony Brook University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adhesion of Flexor Tendon of Hand

Keywords

Flexor Tendon Adhesions, Zone II of the Hand

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Collagenase Injection

Arm Type

Experimental

Arm Description

Injection of collagenase into adhesion restricting tendon gliding

Intervention Type

Drug

Intervention Name(s)

Collagenase

Other Intervention Name(s)

Collagenase Clostridium Histolyticum

Intervention Description

Collagenase injection into adhesion restricting tendon gliding

Intervention Type

Drug

Intervention Name(s)

Collagenase injection

Other Intervention Name(s)

Collagenase Clostridium Histolyticum

Intervention Description

injection of collagenase into adhesion restricting tendon gliding

Primary Outcome Measure Information:

Title

Restoration of PIP and DIP joint motion.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Hand Grip strength (kg)

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marie A Badalamente, PhD

Organizational Affiliation

Dept. Orthopaedics, SUNY@Stony Brook, NY 11794

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Edward Wang, MD

Organizational Affiliation

Dept. Orthopaedics, SUNY@Stony Brook, NY 11794

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dept. Orthopaedics, SUNY@Stony Brook

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11794

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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