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Comparing Primary With Secondary Repair of Based on Electrodiagnostic Assessment and Clinical Examination

Study of Surgical Methods for Repair of Clean Transections in Peripheral Nerve Injuries

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01116362
Enrollment
46
Registered
2010-05-05
Start date
2008-03-31
Completion date
2009-12-31
Last updated
2010-05-20

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

Conditions

Peripheral Nerve Injury

Keywords

ulna, median, repair, primary

Brief summary

The purpose of this study is to determine which surgical approach is better for clean transection injury in peripheral nerves in outcomes.

Detailed description

Treatment of injuries to major nerve trunks in the hand and upper extremity remains a major and challenging reconstructive problem. Our goal was to compare primary versus secondary repair of median and\\or ulnar nerve by electrodiagnostic assessment and clinical examination.

Interventions

during the first days,the nerve was conducted to repair as end to end (epi-epineurium, epi-epineurium) anastomosis. This was performed following the repair of present tendons and muscle injuries.

PROCEDUREsecondary repair

after one week,the nerve was conducted to repair as end to end (epi-epineurium, epi-epineurium) anastomosis. This was performed following the repair of present tendons and muscle injuries.

Sponsors

Isfahan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* patients with confirmed clean transection injury between shoulder and wrist

Exclusion criteria

* crush injuries

Design outcomes

Primary

MeasureTime frameDescription
motor functionat 18 months post-operativelyidentification of motor level were done based on British Medical Research Council guided.The abductor pollicis brevis (APB) was used for the median nerve and the abductor digiti minimi (ADM) for the ulnar nerve. as follows: 0, M0, M1 and M2; 1, M3; 2, M4.

Secondary

MeasureTime frameDescription
sensory recoveryat 18 months post-operativelyidentification of motor and sensory level were done based on British Medical Research Council guided.The abductor pollicis brevis (APB) was used for the median nerve and the abductor digiti minimi (ADM) for the ulnar nerve. The results scored as follows: 0, S0, S1 and S2; 1, S3; 2, S4 and S5.
nerve conduction velocityat 18 months post-operativelyFor electrodiagnostic assessment, nerve conduction velocity (NCV) was tested as motor and sensory. The results categorized according to the Yale sensory scale and the severity of sensation and function of the nerves was scored as follows: 0, no sensation; 1, decreased or abnormal sensation; 2, normal sensation.
electromyographyat 18 months post-operativelyFor an EMG, a needle electrode was inserted through the skin into the muscle which injured nerve supplied. The presence, size and shape of the waveform registered and the ability of the muscle to respond when the nerves were stimulated. Also these results scored as follows: 0, no activity; 1, few or single movement; 2, partial activity; 3, full activity.

Countries

Iran

Outcome results

None listed

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