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Human acellular nerve graft for repair of peripheral nerve defects: a prospective, multicenter clinical study

Human acellular nerve graft for repair of peripheral nerve defects: a prospective, multicenter clinical study

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-TNRC-11001665
Enrollment
Unknown
Registered
2011-11-01
Start date
2009-11-04
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Peripheral nerve injury in the upper limbs(radial nerve,median nerve,ulna nerve)

Interventions

Test group:use acellular nerve graft to bridge the nerve defects
Control group:use nerve autograft or direct suture to bridge the nerve defects.

Sponsors

The Sixth Affiliated Hospital of Shanghai Jiao Tong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. had radial nerve, median nerve or ulna nerve defects and were willing to participate in this clinical trial; 2. were >14 years of age; 3. had a nerve defect that can be repaired with nerve graft of 2-5 cm in length or required traditional repairs(include nerve autograft or direct suture); 4. the duration of injury was less than 6 months; 5. were willing to sign an informed consent form to receive examinations, treatment, and postoperative follow-up.

Exclusion criteria

Exclusion criteria: 1) patients with acute infections, severe wound contamination, unstable vital signs, or functional assessment of nerve repair could not be performed due to skin damage innervated by the nerve that required repair; 2) patients for whom functional assessment could not be performed due to joint stiffness controlled by the muscles innervated by nerves that required repair; 3) patients with neurological diseases or other diseases such as diabetes that may potentially affect the nervous system; 4) patients with chronic diseases, including gout and collagen disease, alcohol addiction, alcoholism, liver impairment, or renal dysfunction; 5) patients with poor compliance and patients who could not complete examinations, treatment, postoperative rehabilitation, or follow-up.

Design outcomes

Primary

MeasureTime frame
BMRC M0-M5;

Secondary

MeasureTime frame
BMRC S0-S4;

Countries

China

Contacts

Public ContactXiaolin Liu
peterhe400@yahoo.com.cn+86 13570506043

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026