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

Stony Brook University3 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Adhesion of Flexor Tendon of Hand

Interventions

CollagenaseDRUG

Collagenase injection into adhesion restricting tendon gliding

Collagenase injectionDRUG

injection of collagenase into adhesion restricting tendon gliding

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 (1)

Dept. Orthopaedics, SUNY@Stony Brook

Stony Brook, New York, United States

Outcomes

Primary Outcomes

Restoration of PIP and DIP joint motion.

Time frame: 6 months

Secondary Outcomes

Hand Grip strength (kg)

Time frame: 6 months

Data from ClinicalTrials.gov

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