| Primary | Motor Functional Recovery (MRC Grade ≥ M3) | 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. | | Posted | | Count of Participants | | Participants | | 2 months post-operative | | | | ID | Title | Description |
|---|
| OG000 | HPTC Nerve Wrap Arm | Participants undergoing peripheral nerve procedures-including nerve repair, coaptation, grafting, nerve transfer, or decompression-in whom a High-Purity Type I Collagen (HPTC) membrane is used intraoperatively as a circumferential nerve wrap. Outcomes related to motor recovery, sensory recovery, neuropathic pain, complications, and patient-reported functional status are prospectively assessed. High-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. |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Primary | Sensory Recovery - Two-Point Discrimination | 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. | | Posted | | Mean | Standard Deviation | millimeter | | 2 months post-operative | | | | ID | Title | Description |
|---|
| OG000 | HPTC Nerve Wrap Arm | Participants undergoing peripheral nerve procedures-including nerve repair, coaptation, grafting, nerve transfer, or decompression-in whom a High-Purity Type I Collagen (HPTC) membrane is used intraoperatively as a circumferential nerve wrap. Outcomes related to motor recovery, sensory recovery, neuropathic pain, complications, and patient-reported functional status are prospectively assessed. High-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. |
| |
| Primary | Number of Participants With Sensory Recovery Assessed by Semmes-Weinstein Monofilament Testing | 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. | | Posted | | Count of Participants | | Participants | | 2 months post-operative | | | | ID | Title | Description |
|---|
| OG000 | HPTC Nerve Wrap Arm | Participants undergoing peripheral nerve procedures-including nerve repair, coaptation, grafting, nerve transfer, or decompression-in whom a High-Purity Type I Collagen (HPTC) membrane is used intraoperatively as a circumferential nerve wrap. Outcomes related to motor recovery, sensory recovery, neuropathic pain, complications, and patient-reported functional status are prospectively assessed. High-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. |
| |
| Secondary | Neuropathic Pain Intensity | Neuropathic pain intensity measured using the Visual Analog Scale (VAS), where 0 represents no pain and 10 represents worst imaginable pain. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, 1 month, and 2 months post-operative | | | | ID | Title | Description |
|---|
| OG000 | HPTC Nerve Wrap Arm | Participants undergoing peripheral nerve procedures-including nerve repair, coaptation, grafting, nerve transfer, or decompression-in whom a High-Purity Type I Collagen (HPTC) membrane is used intraoperatively as a circumferential nerve wrap. Outcomes related to motor recovery, sensory recovery, neuropathic pain, complications, and patient-reported functional status are prospectively assessed. High-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. |
| |
| Secondary | Upper Limb Patient-Reported Functional Outcome (QuickDASH) | 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. | This outcome was assessed only in participants with upper limb nerve involvement. Therefore, the analysis population includes 29 participants corresponding to the upper limb subgroup. | Posted | | Mean | Standard Deviation | score on a scale | | 1 month and 2 months post-operative | | | | ID | Title | Description |
|---|
| OG000 | HPTC Nerve Wrap Arm | Participants undergoing peripheral nerve procedures-including nerve repair, coaptation, grafting, nerve transfer, or decompression-in whom a High-Purity Type I Collagen (HPTC) membrane is used intraoperatively as a circumferential nerve wrap. Outcomes related to motor recovery, sensory recovery, neuropathic pain, complications, and patient-reported functional status are prospectively assessed. High-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. |
| |
| Secondary | Lower Limb Patient-Reported Functional Outcome (LEFS) | 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. | This outcome was assessed only in participants with lower limb nerve involvement. Therefore, the analysis population includes 11 participants corresponding to the lower limb subgroup. | Posted | | Mean | Standard Deviation | score on a scale | | 1 month and 2 months post-operative | | | | ID | Title | Description |
|---|
| OG000 | HPTC Nerve Wrap Arm | Participants undergoing peripheral nerve procedures-including nerve repair, coaptation, grafting, nerve transfer, or decompression-in whom a High-Purity Type I Collagen (HPTC) membrane is used intraoperatively as a circumferential nerve wrap. Outcomes related to motor recovery, sensory recovery, neuropathic pain, complications, and patient-reported functional status are prospectively assessed. High-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. |
| |
| Secondary | Patient Satisfaction | 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. | | Posted | | Count of Participants | | Participants | | 2 months post-operative | | | | ID | Title | Description |
|---|
| OG000 | HPTC Nerve Wrap Arm | Participants undergoing peripheral nerve procedures-including nerve repair, coaptation, grafting, nerve transfer, or decompression-in whom a High-Purity Type I Collagen (HPTC) membrane is used intraoperatively as a circumferential nerve wrap. Outcomes related to motor recovery, sensory recovery, neuropathic pain, complications, and patient-reported functional status are prospectively assessed. High-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. |
| |