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

Adhesion of Flexor Tendon of Hand Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00261209
• Other study ID #: Tendon 101
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 30, 2005
• Last updated: April 20, 2016
• Start date: January 2005
• Est. completion date: January 2008

Study information

• Verified date: April 2016
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Adhesion of Flexor Tendon of Hand
• Tissue Adhesions

Intervention

Drug:
• Collagenase
Collagenase injection into adhesion restricting tendon gliding
• Collagenase injection
injection of collagenase into adhesion restricting tendon gliding

Locations

Country	Name	City	State
United States	Dept. Orthopaedics, SUNY@Stony Brook	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Restoration of PIP and DIP joint motion.		6 months	Yes
Secondary	Hand Grip strength (kg)		6 months	Yes