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

Primary Purpose

Peripheral Nerve Injury

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
primary repair
secondary repair
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Nerve Injury focused on measuring ulna, median, repair, primary

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients with confirmed clean transection injury between shoulder and wrist

Exclusion Criteria:

  • crush injuries

Sites / Locations

  • Al-zahra university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

secondary repair

primary repair

Arm Description

secondary closure beyond the first 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.

during 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.

Outcomes

Primary Outcome Measures

motor function
identification 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 Outcome Measures

sensory recovery
identification 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 velocity
For 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.
electromyography
For 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.

Full Information

First Posted
May 3, 2010
Last Updated
May 19, 2010
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01116362
Brief Title
Comparing Primary With Secondary Repair of Based on Electrodiagnostic Assessment and Clinical Examination
Official Title
Study of Surgical Methods for Repair of Clean Transections in Peripheral Nerve Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Nerve Injury
Keywords
ulna, median, repair, primary

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
secondary repair
Arm Type
Other
Arm Description
secondary closure beyond the first 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.
Arm Title
primary repair
Arm Type
Other
Arm Description
during 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.
Intervention Type
Procedure
Intervention Name(s)
primary repair
Other Intervention Name(s)
NCV,EMG
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
secondary repair
Other Intervention Name(s)
NCV,EMG
Intervention Description
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.
Primary Outcome Measure Information:
Title
motor function
Description
identification 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.
Time Frame
at 18 months post-operatively
Secondary Outcome Measure Information:
Title
sensory recovery
Description
identification 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.
Time Frame
at 18 months post-operatively
Title
nerve conduction velocity
Description
For 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.
Time Frame
at 18 months post-operatively
Title
electromyography
Description
For 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.
Time Frame
at 18 months post-operatively

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients with confirmed clean transection injury between shoulder and wrist Exclusion Criteria: crush injuries
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hamidreza shemshaki, MD
Organizational Affiliation
MD,research comittee
Official's Role
Study Chair
Facility Information:
Facility Name
Al-zahra university hospital
City
Isfahan
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Links:
URL
http://www.mui.ac.ir
Description
Isfahan university of medical science

Learn more about this trial

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

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