Brachial Plexus InjuryNCT06313658
Enhancing Functional Hand Recovery Through Nerve Reconstruction in Total Brachial Plexus Birth Injury
An observational study of Brachial Plexus Injury, run by Assiut University at 1 site in Egypt.
Trial summary
Interpreting the published outcomes of hand function in total BPBI is confounded by a lack of clear documentation regarding detailed surgical findings and management strategies. Investigators have followed a well-defined protocol for surgical reconstruction with the primary objective being reinnervation of the lower… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Brachial Plexus Injury
- What is being tested?
- Total brachial plexus exploration and reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2024to 15 Mar 2025
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study will include at least 50 children: Who underwent brachial plexus exploration and reconstruction for total OBPP. who have reached at least four years of follow-up Excluding children who had selective distal neurotization for restoration of specific functions without brachial plexus exploration or who had secondary procedures to the hand.
Who may be able to join
- Patients Who underwent brachial plexus exploration and reconstruction for total OBPP.
- who have reached at least four years of follow-up
Who cannot join
- Excluding children who had selective distal neurotization for restoration of specific functions without brachial plexus exploration or who had secondary procedures to the hand.
Trial locations and contacts
1 site in 1 country.
Yousif ElGammal contact
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospitals
Asyut, 71526
Yousif T El-Gammal, MD, 5023797500, yousif.elgammal@med.aun.edu.eg
About this study
Interpreting the published outcomes of hand function in total BPBI is confounded by a lack of clear documentation regarding detailed surgical findings and management strategies. Investigators have followed a well-defined protocol for surgical reconstruction with the primary objective being reinnervation of the lower trunk using the best available root. In this paper, Investigators outline the details of the strategy and provide a comprehensive analysis of the nerve reconstruction techniques and the resulting functional outcomes.
Read the detailed description
Managing total BPBI cases is complex because surgical reconstruction must address the restoration of shoulder, elbow, and hand functions. In cases where multiple nerve root avulsions are present, prioritizing which functions to reinnervate shoulder, elbow, or hand becomes a critical decision. While attempts to restore hand function in adults with total brachial plexus lesions have yielded disappointing results, it has been shown that restoring hand function in infants with BPBI is more promising due to their enhanced neuro-regenerative capacities. Interpreting published outcomes of hand function in total BPBI is confounded by a lack of clear documentation regarding detailed surgical findings and management strategies. Various hand function scales that measure the individual joint movements or the global function of the hand and wrist have been used in the assessment of the outcomes, but none has quantitated the recovery of the intrinsic muscles of the digits or thumb. Furthermore, it is well-documented that the recovery of hand function can be a prolonged process, often extending up to eight years before reaching a plateau. The majority of the published studies have typically reported outcomes based on a minimum follow-up period of two years, which may not provide sufficient time to assess the full extent of hand function recovery.
Investigators have followed a well-defined protocol for the surgical reconstruction of total BPBI with the primary objective being restoration of hand function through reinnervation of the lower trunk followed by restoration of elbow and shoulder functions through innervation of the upper trunk. In this paper, Investigators outline the details of the surgical strategy and provide a comprehensive analysis of the nerve reconstruction techniques and the resulting functional outcomes. Furthermore, investigators explore and identify the factors that may significantly impact the recovery process.
- Conditions
- Brachial Plexus Injury
- Being tested
- Total brachial plexus exploration and reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total brachial plexus exploration and reconstructionProcedure or surgery
In the adopted strategy, anatomical reconstruction was always performed when feasible and the lower trunk was considered the primary reinnervation target. Anatomical reconstruction of the plexus was attempted in the presence of at least three available roots; the best quality root stump (usually C5) was used for hand reanimation, while the lower ruptured roots were directed towards the upper and middle trunks. If one or more of the remaining root stumps were of doubtful quality, the compromised roots were grafted to the posterior divisions of the upper and middle trunks, while elbow flexion could be restored by transferring the intercostal nerves (T3-5) to the lateral cord. The lateral root of the median nerve was also included in the intercostal nerve transfer to restore hand sensations. In all cases, the spinal accessory nerve was directly sutured to the suprascapular nerve to restore rotator cuff function.
What is being measured
The primary outcome is the main question the study is designed to answer.
Active Movement Scale (AMS)
All patients included in the study were evaluated using the Active Movement Scale (AMS), which grades upper extremity movements from 0 to 7. Scores of 6 or 7 would be considered successful in demonstrating functionally useful movement; this is a 50% and full range of movement against gravity, respectively.Attention was focused on sex movements primarily involving hand function including wrist, finger, and thumb flexion and extension.
Measured: 1 year
Secondary outcomes (2)
Al-Qattan pronation/Supination score
Separate assessments were performed of forearm pronation/supination as described by Al-Qattan
Measured: 1 year
Raimondi hand score
Global hand function was assessed using the Raimondi scale; a score of 3 or more indicate a useful functional recovery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start15 Mar 2024 (estimated)
- Primary completion15 Mar 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Brachial Plexus 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yousif Tarek El-Gammal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313658
- Sponsor's protocol ID
- Total BPBI
- Status last verified
- Mar 2024
- First submitted
- 2 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haerle M, Gilbert A. Management of complete obstetric brachial plexus lesions. J Pediatr Orthop. 2004 Mar-Apr;24(2):194-200. doi: 10.1097/00004694-200403000-00012.
PubMed 15076607Al-Qattan MM. Assessment of the motor power in older children with obstetric brachial plexus palsy. J Hand Surg Br. 2003 Feb;28(1):46-9. doi: 10.1054/jhsb.2002.0831.
PubMed 12531668Borschel GH, Clarke HM. Obstetrical brachial plexus palsy. Plast Reconstr Surg. 2009 Jul;124(1 Suppl):144e-155e. doi: 10.1097/PRS.0b013e3181a80798.
PubMed 19568147Pondaag W, Malessy MJ. Recovery of hand function following nerve grafting and transfer in obstetric brachial plexus lesions. J Neurosurg. 2006 Jul;105(1 Suppl):33-40. doi: 10.3171/ped.2006.105.1.33.
PubMed 16871868
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Functional Hand Recovery Through Nerve Reconstruction in Total Brachial Plexus Birth Injury
- ClinicalTrials.gov ID
- NCT06313658
- Acronym / sponsor ID
- Total BPBI
- Conditions
- Brachial Plexus Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 15 Mar 2024 (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.
Interpreting the published outcomes of hand function in total BPBI is confounded by a lack of clear documentation regarding detailed surgical findings and management strategies. Investigators have followed a well-defined protocol for surgical reconstruction with the primary objective being reinnervation of the lower trunk using the best available root. In this paper, Investigators outline the details of the strategy and provide a comprehensive analysis of the nerve reconstruction techniques and the resulting functional outcomes.
Detailed description
Managing total BPBI cases is complex because surgical reconstruction must address the restoration of shoulder, elbow, and hand functions. In cases where multiple nerve root avulsions are present, prioritizing which functions to reinnervate shoulder, elbow, or hand becomes a critical decision. While attempts to restore hand function in adults with total brachial plexus lesions have yielded disappointing results, it has been shown that restoring hand function in infants with BPBI is more promising due to their enhanced neuro-regenerative capacities. Interpreting published outcomes of hand function in total BPBI is confounded by a lack of clear documentation regarding detailed surgical findings and management strategies. Various hand function scales that measure the individual joint movements or the global function of the hand and wrist have been used in the assessment of the outcomes, but none has quantitated the recovery of the intrinsic muscles of the digits or thumb. Furthermore, it is well-documented that the recovery of hand function can be a prolonged process, often extending up to eight years before reaching a plateau. The majority of the published studies have typically reported outcomes based on a minimum follow-up period of two years, which may not provide sufficient time to assess the full extent of hand function recovery.
Investigators have followed a well-defined protocol for the surgical reconstruction of total BPBI with the primary objective being restoration of hand function through reinnervation of the lower trunk followed by restoration of elbow and shoulder functions through innervation of the upper trunk. In this paper, Investigators outline the details of the surgical strategy and provide a comprehensive analysis of the nerve reconstruction techniques and the resulting functional outcomes. Furthermore, investigators explore and identify the factors that may significantly impact the recovery process.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will include at least 50 children: Who underwent brachial plexus exploration and reconstruction for total OBPP. who have reached at least four years of follow-up Excluding children who had selective distal neurotization for restoration of specific functions without brachial plexus exploration or who had secondary procedures to the hand.
Key inclusion criteria (2 listed)
- Patients Who underwent brachial plexus exploration and reconstruction for total OBPP.
- who have reached at least four years of follow-up
Key exclusion criteria (1 listed)
- Excluding children who had selective distal neurotization for restoration of specific functions without brachial plexus exploration or who had secondary procedures to the hand.
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 |
|---|---|---|
| Total brachial plexus exploration and reconstructionIn the adopted strategy, anatomical reconstruction was always performed when feasible and the lower trunk was considered the primary reinnervation target. Anatomical reconstruction of the plexus was attempted in the presence of at least three available roots; the best quality root stump (usually C5) was used for hand reanimation, while the lower ruptured roots were directed towards the upper and middle trunks. If one or more of the remaining root stumps were of doubtful quality, the compromised roots were grafted to the posterior divisions of the upper and middle trunks, while elbow flexion could be restored by transferring the intercostal nerves (T3-5) to the lateral cord. The lateral root of the median nerve was also included in the intercostal nerve transfer to restore hand sensations. In all cases, the spinal accessory nerve was directly sutured to the suprascapular nerve to restore rotator cuff function. | Procedure or surgery | – |
Primary outcome
Active Movement Scale (AMS)
Time frame: 1 year
All patients included in the study were evaluated using the Active Movement Scale (AMS), which grades upper extremity movements from 0 to 7. Scores of 6 or 7 would be considered successful in demonstrating functionally useful movement; this is a 50% and full range of movement against gravity, respectively.Attention was focused on sex movements primarily involving hand function including wrist, finger, and thumb flexion and extension.
2 secondary outcomes
Al-Qattan pronation/Supination score
Time frame: 1 year
Raimondi hand score
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Background: PubMed 15076607Haerle M, Gilbert A. Management of complete obstetric brachial plexus lesions. J Pediatr Orthop. 2004 Mar-Apr;24(2):194-200. doi: 10.1097/00004694-200403000-00012.
- Background: PubMed 12531668Al-Qattan MM. Assessment of the motor power in older children with obstetric brachial plexus palsy. J Hand Surg Br. 2003 Feb;28(1):46-9. doi: 10.1054/jhsb.2002.0831.
- Background: PubMed 19568147Borschel GH, Clarke HM. Obstetrical brachial plexus palsy. Plast Reconstr Surg. 2009 Jul;124(1 Suppl):144e-155e. doi: 10.1097/PRS.0b013e3181a80798.
- Background: PubMed 16871868Pondaag W, Malessy MJ. Recovery of hand function following nerve grafting and transfer in obstetric brachial plexus lesions. J Neurosurg. 2006 Jul;105(1 Suppl):33-40. doi: 10.3171/ped.2006.105.1.33.
- Individual participant dataSharing planned: No
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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.
Yousif ElGammal contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brachial Plexus Injury, run by Assiut University at 1 site in Egypt.
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 2 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: status not confirmed, as of the sponsor's last update on 15 Mar 2024. 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 Egypt. 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.
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 Yousif T El-Gammal (5023797500 ext. +1, yousif.elgammal@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active Movement Scale (AMS) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06313658, which also lists 4 linked publications.
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 15 Mar 2024.