- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05283785
Ulnar Nerve Neurotization After Ulnar Nerve Injury
March 17, 2022 updated by: Mario Samwel Shawkey Basilios, Assiut University
Evaluation of Hand Intrinsic Muscles Functional Recovery After Distal Neurotization of Ulnar Nerve
This study will evaluate the hand intrinsic muscles functional recovery after distal neurotization of ulnar nerve
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
- ulnar nerve injuries result in loss of both the sensory and motor elements within the hand. these injuries can be classified by the site of injury into low injuries and high injuries. In low ulnar nerve injuries, the nerve is injured distal to the motor branch of the Flexor carpi ulnaris (FCU) and motor branch to the Flexor digitorum profundus (FDP) of the ring and little fingers. In low injuries, sensation is lost in palmar ulnar hand and paralysis occurs usually to all 7 interossei, the ulnar 2 lumbrical, the 3 hypothenar, the adductor pollicis, and the deep head of the flexor pollicis brevis muscles .
- After peripheral nerve lesion axonal regeneration is at a rate of 1-2 mm/day. Because muscle fibers undergo irreversible changes after 12 months of denervation, it is important that treatment be undertaken as early as possible for successful functional recovery .
- "Babysitting" nerve fiber transfers can be defined as giving fibers from a healthy donor trunk to a denervated recipient trunk, in order to allow these fibers reach the distal effectors to avoid atrophy; such a procedure has originally been described together with partial neurotomy and has been found to be efficient both in experimental and clinical studies
- As far as it concerns proximal ulnar nerve injuries, babysitting by end-to-side nerve transfer has proven effective in 1 of the 3 series reported, where Colonna et al. analyzed an alternative Martin Grubertype( type of of operation) connection created by a bridge nerve graft between median (donor) and ulnar (recipient) trunks in the distal forearm, which gave interesting, but not ideal results ; "supercharged" reverse end-to side nerve transfers have been reported in latter studies . another person reported 7 cases of distal anterior interosseous to ulnar nerve end-to-end coaptation together with palmar cutaneous branch of the median nerve to the ulnar nerve above the wrist in a previous paper . it has not yet been well-established whether end-to-end or end-to-side gives better results.
nowadays, surgeons performing this type of surgery complain inconsistent outcomes, maybe as an effect of the discrepancy between the number of fibers in donor nerves and those in the recipient one
Study Type
Observational
Enrollment (Anticipated)
22
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mario S Shawkey Basilios, resident
- Phone Number: 01007936606
- Email: Mariobasilios492@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
- test adductor pollicis muscle.
- test palmar inter-osseii.
- test dorsal inter-osseii.
test lumbricals.
Investigations:
Radiological:
- Plain X-ray
- EMG and nerve conduction velocity
- Laboratory : Full laboratory investigations
Steps of action and techniques used:
Pre-operative preparation:
- recording of pre-existing muscle power,
- Clarifying of realistic goals before the surgery,
- anti-biotic within 1 hour before surgery> . Surgical techniques transfer of the motor branch of the anterior interosseous nerve that supply pronator quadrates muscle to the motor division of the ulnar nerve ( the deep branch of the ulnar nerve ) by end to end or end to side suture
Description
Inclusion Criteria:
- Site of the injury: at or proximal to level of the elbow
- Nature of the injury; post traumatic injury.
- Sex; both males and females.
- Age; any age.
- Time of presentation of injury: less than 6 months from injury.
Exclusion Criteria:
- Any patient with non-post traumatic injury either inflammatory or tumor caused palsy or idiopathic.
- Any distal injury below origin of FCU branch.
- Delayed presentation after 6 months of injury.
- Any patient refusing participation in this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
( group 1)
End to End sutures
|
End to end or End to side sutures of ulnar nerve by nerve to quadratus muscle ( branch of anterior interosseous nerve )
|
|
( group 2 )
End to Side sutures
|
End to end or End to side sutures of ulnar nerve by nerve to quadratus muscle ( branch of anterior interosseous nerve )
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
evaluate the hand intrinsic muscles functional recovery after distal neurotization of ulnar nerve
Time Frame: 8 months
|
(1) Evaluation of hand intrinsic muscle functional recovery by : A- Muscle power by standard Medical Research Council (MRC) grading B- grip strength by dynamometer C- pinch strength will done based on grading of adductor pollicis muscle.
D- Evaluation of clawing will done based on clinical observation E- DASH( Disabilities of the Arm, Shoulder and Hand ) score pre and post
|
8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Amr El-Sayed A Ibrahim, Prof Dr, Orthopedic and Microsurgery department , assiut university hospital
- Study Director: Yasser M Farouk Ragheb, Lecturar, Orthopedic and Microsurgery department , assiut university hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
October 1, 2022
Primary Completion (ANTICIPATED)
October 1, 2024
Study Completion (ANTICIPATED)
December 1, 2024
Study Registration Dates
First Submitted
March 2, 2022
First Submitted That Met QC Criteria
March 14, 2022
First Posted (ACTUAL)
March 17, 2022
Study Record Updates
Last Update Posted (ACTUAL)
March 31, 2022
Last Update Submitted That Met QC Criteria
March 17, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ulnar nerve neurotization
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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