NCT06117501

Nerve Protection Evaluation: Revision Cubital Tunnel Syndrome Decompression

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Axogen Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This single-cohort, prospective case series is designed to evaluate and characterize the use of Axoguard HA+ Nerve Protector™ to protect the ulnar nerve in a first revision cubital tunnel decompression procedure. Data on the primary cubital tunnel syndrome decompression, first revision decompression utilizing Axoguard HA+ Nerve Protector, participant-reported pain, motor and sensory functional outcomes, quality of life (QoL) outcomes, and recurrence/revision will be collected. This case series will help to establish the ability of Axoguard HA+ Nerve Protector to provide clinical benefits for patients undergoing a first revision cubital tunnel decompression procedure.

Detailed description

The objectives of this study are: 1. To evaluate the use and characterize the performance of Axoguard HA+ Nerve Protector to protect the ulnar nerve in a first revision cubital tunnel decompression by understanding post-operative outcomes (pain level, QoL, PROMs, and ulnar nerve specific functional outcomes) compared to baseline (pre-revision operative levels). 2. To summarize the safety of Axoguard HA+ Nerve Protector, an FDA-cleared device, in first revision cubital tunnel decompression procedures. 3. To characterize the feasibility of Axoguard HA+ Nerve Protector to prevent the recurrence of compressive neuropathy of the ulnar nerve at the elbow and resulting need for future revision procedures. 4. To characterize the feasibility of imaging the ulnar nerve pre- and post-operatively to assess nerve and tissue bed health. The study population includes participants 18 years of age or older presenting for evaluation of surgery for compressive ulnar nerve neuropathy at the elbow following a primary cubital tunnel syndrome decompression. Data will be collected from available medical records and patient reported outcomes questionnaires using approved data collection forms (paper or electronic). The following data will be collected at the respective study visits: demographics, primary decompression details, revision decompression details, baseline assessments, health-related QoL questionnaires, functional assessments, and recovery assessments. There will be a total of nine (9) study visits (Pre-op Screening/Baseline and Operative Day visits plus seven (7) study follow-up events).

Conditions

• Recurrent Cubital Tunnel Syndrome
• Recalcitrant Cubital Tunnel Syndrome

Interventions

Type	Name	Description
DEVICE	Axoguard HA+ Nerve Protector™	Axoguard HA+ Nerve Protector™ is a surgical implant that provides non-constricting protection for non-transected peripheral nerve injuries where there is no gap. Axoguard HA+ Nerve Protector™ is designed to be an interface between the nerve and the surrounding tissue.

Timeline

• Start date: 2023-10-19
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-11-07
• Last updated: 2025-10-07

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study