N/A
Completed N=60
Evaluation of High-Purity Type I Collagen Biologic Wrap to Improve Function After Extensor Tendon Repair of the Hand
Injury of Extensor Tendon of Hand · Tendon Adhesions
Source: ClinicalTrials.gov NCT07335653 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcomePrimary: Total Active Motion (TAM) of Involved Finger(s) — 232.4; 201.3 degrees
Summary
Tendon injuries of the hand, particularly extensor tendons, are prone to postoperative adhesions, extensor lag, and stiffness, leading to functional impairment. This multicentric randomized controlled trial evaluates whether wrapping repaired extensor tendons with a high-purity Type I collagen (HPTC) biologic membrane can reduce adhesion formation and improve functional outcomes compared with standard repair alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Active Motion (TAM) of Involved Finger(s) |
232.4; 201.3 | — |
| SECONDARY QuickDASH Score |
24.5; 39.8; 18.2; 32.6 | — |
| SECONDARY Extensor Lag |
6.4; 15.7 | — |
| SECONDARY Number of Participants With Clinically Significant Tendon Adhesions |
2; 9 | — |
| SECONDARY Grip Strength |
78.6; 63.2 | — |
| SECONDARY Time to Return to Work or Activities of Daily Living |
5.6; 7.9 | — |
| SECONDARY Patient Satisfaction |
8.9; 7.1 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18-65 years.
- Acute open laceration of extensor tendons in zone VI, VII, or VIII of the hand / wrist (according to Verdan's classification), involving digits 2-5 and/or wrist extensors.
- Complete tendon laceration (≥50% tendon cross-sectional area), requiring primary repair.
- Time from injury to surgical repair ≤72 hours.
- Single upper limb involved.
- Ability and willingness to comply with postoperative rehabilitation protocol and follow-up visits.
- Provision of written informed consent.
Exclusion Criteria
- Crush, avulsion, or segmental tendon loss requiring graft or tendon transfer.
- Associated open fractures requiring dorsal plating across the repair site, or extensive bone loss affecting joint stability.
- Previous surgery or significant scarring over the injured extensor tendon region.
- Associated major nerve injury requiring graft or complex reconstruction (digital nerve repair without grafting may be allowed if balanced between groups).
- Uncontrolled systemic illness (e.g., HbA1c > 8.5% for diabetes, severe peripheral vascular disease, chronic steroid use, severe malnutrition).
- Active infection at the injury site.
- Known allergy or hypersensitivity to bovine/ovine collagen or any component of HPTC.
- Pregnancy or lactation.
- Inability to provide informed consent or comply with follow-up.
Data sourced from ClinicalTrials.gov (NCT07335653). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.