NCT Number: NCT07360730
This prospective multicentre observational registry evaluates early clinical outcomes following the use of High-Purity Type I Collagen (HPTC) as a circumferential nerve wrap during peripheral nerve procedures. Eligible procedures include nerve repair, coaptation, grafting, nerve transfers, and decompressions in the upper and lower limbs.
Primary outcomes include early motor recovery assessed using the Medical Research Council (MRC) motor grading system. Secondary outcomes include sensory recovery, neuropathic pain, patient-reported functional outcomes, complication rates, and patient satisfaction assessed at standardized postoperative intervals up to two months.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Adichunchanagiri Institute of Medical Sciences, Mandya, Karnataka, India
Peripheral nerve surgery outcomes are often compromised by perineural fibrosis, neuroma formation, and unpredictable axonal regeneration. High-Purity Type I Collagen (HPTC) is a bioengineered resorbable collagen membrane designed to act as a biologic scaffold and perineural barrier, potentially reducing scar adherence and facilitating nerve gliding.
This prospective registry enrolls adult patients undergoing peripheral nerve procedures where HPTC is used as an adjunct circumferential nerve wrap. Functional motor recovery, sensory recovery, pain scores, patient-reported outcomes, and complications will be systematically documented at baseline and follow-up intervals up to four months. This registry aims to generate real-world, multicentre evidence regarding the safety and early clinical effectiveness of HPTC nerve wrapping.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After completion of nerve repair, coaptation, grafting, transfer, or decompression, a sterile HPTC collagen membrane is hydrated as per manufacturer instructions, trimmed to the length of the treated nerve segment (approximately 1.5-4 cm), and wrapped circumferentially as a loose perineural sleeve. The wrap is secured using fibrin glue or fine absorbable sutures. Standard wound closure and postoperative rehabilitation protocols are followed.
Time frame: 2 months post-operative
Motor recovery of the involved muscle groups assessed using the Medical Research Council (MRC) Motor Grading system. Successful recovery was defined as achievement of MRC grade ≥ M3, representing active movement against gravity.
Time frame: 2 months post-operative
Sensory recovery assessed using two-point discrimination testing in the affected nerve distribution, measured as the minimum distance (in millimeters) at which two points are perceived as separate.
Time frame: 2 months post-operative
Number of participants demonstrating sensory recovery as assessed by Semmes-Weinstein monofilament testing at 2 months postoperatively. Sensory recovery was defined as the ability to perceive a clinically meaningful monofilament threshold in the affected nerve distribution. Higher values indicate greater proportion of participants achieving sensory recovery.
Time frame: Baseline, 1 month, and 2 months post-operative
Neuropathic pain intensity measured using the Visual Analog Scale (VAS), where 0 represents no pain and 10 represents worst imaginable pain.
Time frame: 1 month and 2 months post-operative
Upper limb function assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. The QuickDASH consists of 11 items scored on a scale from 0 to 100, where 0 represents no disability and 100 represents maximum disability. Higher scores indicate worse functional outcome.
Time frame: 1 month and 2 months post-operative
Lower limb function assessed using the Lower Extremity Functional Scale (LEFS). The LEFS consists of 20 items with a total score ranging from 0 to 80, where higher scores indicate better functional outcome.
Time frame: 2 months post-operative
Patient satisfaction assessed using a 5-point Likert Satisfaction Scale, with scores ranging from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate greater patient satisfaction.
Adichunchanagiri Institute of Medical Sciences, B G Nagara
Other
Prospective Multicentre Registry of High-Purity Type I Collagen Nerve Wrapping in Peripheral Nerve Procedures: Early Clinical Outcomes
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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