Ulnar Nerve InjuryNCT05283785
Ulnar Nerve Neurotization After Ulnar Nerve Injury
An observational study of Ulnar Nerve Injury, run by Assiut University.
Trial summary
This study will evaluate the hand intrinsic muscles functional recovery after distal neurotization of ulnar nerve Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ulnar Nerve Injury
- What is being tested?
- End To End or End to side sutures
- Type of treatment
- Surgery or procedure
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Dec 2024
- How long will I take part?
- 8 Months
- Phase
- Observational
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: 1. test adductor pollicis muscle. 2. test palmar inter-osseii. 3. test dorsal inter-osseii. 4. 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: 1. recording of pre-existing muscle power, 2. Clarifying of realistic goals before the surgery, 3. 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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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
- Conditions
- Ulnar Nerve Injury
- Being tested
- End To End or End to side sutures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
End To End or End to side suturesProcedure or surgery
End to end or End to side sutures of ulnar nerve by nerve to quadratus muscle ( branch of anterior interosseous nerve )
| Study group | Role | What they receive |
|---|---|---|
| ( group 1) | End to End sutures Receives: Procedure: End To End or End to side sutures | |
| ( group 2 ) | End to Side sutures Receives: Procedure: End To End or End to side sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the hand intrinsic muscles functional recovery after distal neurotization of ulnar nerve
(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
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulnar Nerve InjuryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 22 participants (estimated)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Samwel Shawkey Basilios, Assiut University
- Investigators
- Amr El-Sayed A Ibrahim, Prof Dr, Study director, Orthopedic and Microsurgery department , assiut university hospitalYasser M Farouk Ragheb, Lecturar, Study director, Orthopedic and Microsurgery department , assiut university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283785
- Sponsor's protocol ID
- ulnar nerve neurotization
- Status last verified
- Mar 2022
- First submitted
- 2 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hand Intrinsic Muscles Functional Recovery After Distal Neurotization of Ulnar Nerve
- ClinicalTrials.gov ID
- NCT05283785
- Acronym / sponsor ID
- ulnar nerve neurotization
- Conditions
- Ulnar Nerve Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 17 Mar 2022 (actual)
- 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.
This study will evaluate the hand intrinsic muscles functional recovery after distal neurotization of ulnar nerve
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 8 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ( group 1) | – | Procedure: End To End or End to side suturesEnd to End sutures |
| ( group 2 ) | – | Procedure: End To End or End to side suturesEnd to Side sutures |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. test adductor pollicis muscle. 2. test palmar inter-osseii. 3. test dorsal inter-osseii. 4. 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: 1. recording of pre-existing muscle power, 2. Clarifying of realistic goals before the surgery, 3. 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| End To End or End to side suturesEnd to end or End to side sutures of ulnar nerve by nerve to quadratus muscle ( branch of anterior interosseous nerve ) | Procedure or surgery | ( group 1), ( group 2 ) |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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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.
Amr El-Sayed A Ibrahim, Prof Dr study director
Orthopedic and Microsurgery department , assiut university hospital
Yasser M Farouk Ragheb, Lecturar study director
Orthopedic and Microsurgery department , assiut university hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Ulnar Nerve Injury, run by Assiut University.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mario S Shawkey Basilios, resident (01007936606, Mariobasilios492@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the hand intrinsic muscles functional recovery after distal neurotization of ulnar nerve (time frame: 8 months). 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 31 Mar 2022.