N/A
Completed N=40
High-Purity Type I Collagen Nerve Wrapping in Peripheral Nerve Procedures: A Prospective Registry
Peripheral Nerve Injuries · Neuroma of Nerve Repair · Nerve Graft; Complications, Mechanical · Peripheral Nerve Decompression Injury
Source: ClinicalTrials.gov NCT07360730 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcomePrimary: Motor Functional Recovery (MRC Grade ≥ M3) — 34 Participants
Summary
This prospective multicentre observational registry evaluates early clinical outcomes following the use of High-Purity Type I Collagen (HPTC) as a circumferential nerve wrap during peripheral nerve procedures. Eligible procedures include nerve repair, coaptation, grafting, nerve transfers, and decompressions in the upper and lower limbs.
Primary outcomes include early motor recovery assessed using the Medical Research Council (MRC) motor grading system. Secondary outcomes include sensory recovery, neuropathic pain, patient-reported functional outcomes, complication rates, and patient satisfaction assessed at standardized postoperative intervals up to two months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Motor Functional Recovery (MRC Grade ≥ M3) |
34 | — |
| PRIMARY Sensory Recovery - Two-Point Discrimination |
8.6 | — |
| PRIMARY Number of Participants With Sensory Recovery Assessed by Semmes-Weinstein Monofilament Testing |
27 | — |
| SECONDARY Neuropathic Pain Intensity |
6.8; 5.0; 2.4 | — |
| SECONDARY Upper Limb Patient-Reported Functional Outcome (QuickDASH) |
58.2; 31.4 | — |
| SECONDARY Lower Limb Patient-Reported Functional Outcome (LEFS) |
53.7; 68.9 | — |
| SECONDARY Patient Satisfaction |
34; 4; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 to 70 years
- Patients undergoing peripheral nerve procedures including: Primary nerve repair, Nerve coaptation, Nerve grafting, Nerve transfer, Revision nerve decompression
- Upper or lower limb nerve involvement
- Intraoperative use of HPTC nerve wrap
- Ability to comply with follow-up
- Written informed consent provided
Exclusion Criteria
- Active infection at the surgical site
- Known hypersensitivity to collagen products
- Severe uncontrolled systemic illness
- Pregnancy or lactation
- Re-operation at the same nerve site within the previous 6 months
- Inability to provide informed consent
Data sourced from ClinicalTrials.gov (NCT07360730). 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.