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Completed

NCT Number: NCT00261209

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

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

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Key information

Conditions

Adhesion of Flexor Tendon of Hand

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Dept. Orthopaedics, SUNY@Stony Brook

Stony Brook, New York, 11794, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Collagenase

Drug

Collagenase injection into adhesion restricting tendon gliding

Other names: Collagenase Clostridium Histolyticum

collagenase injection

Drug

injection of collagenase into adhesion restricting tendon gliding

Other names: Collagenase Clostridium Histolyticum

Primary outcomes

  1. Restoration of PIP and DIP joint motion.

    Time frame: 6 months

Secondary outcomes

  1. Hand Grip strength (kg)

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Dec 2, 2005
Registry last updated
Apr 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.