Peripheral Nerve InjuryPhase 2NCT01116362
Comparing Primary With Secondary Repair of Based on Electrodiagnostic Assessment and Clinical Examination
A Phase 2 study testing primary repair and secondary repair in people with Peripheral Nerve Injury, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine which surgical approach is better for clean transection injury in peripheral nerves in outcomes. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Peripheral Nerve Injury
- What is being tested?
- primary repair and secondary repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteIran
- Study dates
- Mar 2008to Dec 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients with confirmed clean transection injury between shoulder and wrist
Who cannot join
- crush injuries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Surgical Methods for Repair of Clean Transections in Peripheral Nerve Injuries
The purpose of this study is to determine which surgical approach is better for clean transection injury in peripheral nerves in outcomes.
Read the 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.
- Conditions
- Peripheral Nerve Injury
- Being tested
- primary repair, secondary repair
- Keywords
- ulna, median, repair, primary
- Medical subject headings
- Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
primary repairProcedure or surgery
Also called NCV,EMG
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.
secondary repairProcedure or surgery
Also called NCV,EMG
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.
| Study group | Role | What they receive |
|---|---|---|
| secondary repair | Other | 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. Receives: Procedure: secondary repair |
| primary repair | Other | 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. Receives: Procedure: primary repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 18 months post-operatively
Secondary outcomes (3)
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.
Measured: at 18 months post-operatively
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.
Measured: at 18 months post-operatively
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.
Measured: at 18 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startMar 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- hamidreza shemshaki, MD, Study chair, MD,research comittee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116362
- Sponsor's protocol ID
- ASD-1213-2
- Status last verified
- Mar 2008
- First submitted
- 3 May 2010
- Last updated
- 20 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Surgical Methods for Repair of Clean Transections in Peripheral Nerve Injuries
- ClinicalTrials.gov ID
- NCT01116362
- Acronym / sponsor ID
- ASD-1213-2
- Conditions
- Peripheral Nerve Injury
- Keywords
- ulna, median, repair, primary
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 5 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| secondary repair | Other | Procedure: secondary repairsecondary 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. |
| primary repair | Other | Procedure: primary repairduring 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with confirmed clean transection injury between shoulder and wrist
Key exclusion criteria (1 listed)
- crush injuries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| primary repairAlso: NCV,EMGduring 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. | Procedure or surgery | primary repair |
| secondary repairAlso: NCV,EMGafter 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. | Procedure or surgery | secondary repair |
Primary outcome
motor function
Time frame: at 18 months post-operatively
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.
3 secondary outcomes
sensory recovery
Time frame: at 18 months post-operatively
nerve conduction velocity
Time frame: at 18 months post-operatively
electromyography
Time frame: at 18 months post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hamidreza shemshaki, MD study chair
MD,research comittee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing primary repair and secondary repair in people with Peripheral Nerve Injury, run by Isfahan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
motor function (time frame: at 18 months post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2010.