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

Stony Brook University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Adhesion of Flexor Tendon of Hand

Treatments: Drug: Collagenase; Drug: Collagenase injection

Study type: Interventional

Funder types: Other

Identifiers

NCT00261209

Tendon 101

Details and patient eligibility

About

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

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Collagenase Injection

Experimental group

Description:

Injection of collagenase into adhesion restricting tendon gliding

Treatment:

Drug: Collagenase injection

Drug: Collagenase