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

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00261209
Enrollment
3
Registered
2005-12-02
Start date
2005-01-31
Completion date
2008-01-31
Last updated
2016-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adhesion of Flexor Tendon of Hand

Keywords

Flexor Tendon Adhesions, Zone II of the Hand

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.

Interventions

Collagenase injection into adhesion restricting tendon gliding

injection of collagenase into adhesion restricting tendon gliding

Sponsors

Stony Brook University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Restoration of PIP and DIP joint motion.6 months

Secondary

MeasureTime frame
Hand Grip strength (kg)6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026