Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT06313658
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Enhancing Functional Hand Recovery Through Nerve Reconstruction in Total Brachial Plexus Birth Injury
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Enhancing Functional Hand Recovery Through Nerve Reconstruction in Total Brachial Plexus Birth Injury
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: