Nerve Graft; Complications, Mechanical, Neuroma, Neuroma of Nerve Repair, Peripheral Nerve Decompression Injury, Peripheral Nerve Injuries
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEHigh-Purity Type I Collagen (HPTC) Nerve Wrap
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.
Sponsors
Adichunchanagiri Institute of Medical Sciences, B G Nagara
Mysore Medical College and Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 70 years * Patients undergoing peripheral nerve procedures including: Primary nerve repair, Nerve coaptation, Nerve grafting, Nerve transfer, Revision nerve decompression * Upper or lower limb nerve involvement * Intraoperative use of HPTC nerve wrap * Ability to comply with follow-up * Written informed consent provided
Exclusion criteria
* Active infection at the surgical site * Known hypersensitivity to collagen products * Severe uncontrolled systemic illness * Pregnancy or lactation * Re-operation at the same nerve site within the previous 6 months * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor Functional Recovery (MRC Grade ≥ M3) | 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. |
| Sensory Recovery - Two-Point Discrimination | 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. |
| Number of Participants With Sensory Recovery Assessed by Semmes-Weinstein Monofilament Testing | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuropathic Pain Intensity | 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. |
| Upper Limb Patient-Reported Functional Outcome (QuickDASH) | 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. |
| Lower Limb Patient-Reported Functional Outcome (LEFS) | 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. |
| Patient Satisfaction | 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. |
Countries
India
Contacts
STUDY_CHAIRPrema Dhanraj, MS, MCh
Rajarajeshwari Medical College and Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 38.4 years STANDARD_DEVIATION 12.1 |
| Nerve Location Lower Limb | 11 Participants |
| Nerve Location Upper Limb | 29 Participants |
| Procedure Type Nerve decompression | 12 Participants |
| Procedure Type Nerve grafting | 6 Participants |
| Procedure Type Nerve transfer | 8 Participants |
| Procedure Type Primary nerve repair/coaptation | 14 Participants |
| Region of Enrollment India | 40 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 27 Participants |
| Wrap Length | 2.6 centimeters STANDARD_DEVIATION 0.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 2 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
None listed