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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Foundation for Orthopaedic Research and Education (Florida Orthopaedic Institute)
Tampa, Florida, United States
Optim Orthopedics
Savannah, Georgia, United States
Indiana Hand to Shoulder Center
Indianapolis, Indiana, United States
University of New Mexico
Albuquerque, New Mexico, United States
Cleveland Clinic
Cleveland, Ohio, United States
Rothman Orthopaedics
Philadelphia, Pennsylvania, United States
University of Utah
Salt Lake City, Utah, United States
Visual analog scale (VAS)
Change from baseline in visual analog scale (VAS) pain scores (0-100 mm) will be evaluated between post-operative months 6 to 18 to characterize treatment response over time.
Time frame: 6-18 months
Visual Analog Scale (VAS)
Pain will be assessed on each study visit using a 100 mm visual analog scale (VAS).
Time frame: 3 months
Grip strength
Grip strength will be measured for both arms using a hand dynamometer.
Time frame: 18 months
Semmes-Weinstein Monofilament test
Semmes-Weinstein Monofilament test will be performed to assess sensibility by evaluating the tactile sensitivity to pressure in both hands to pressure applied by the monofilaments.
Time frame: 18 months
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score
QuickDASH is a patient-reported outcome questionnaire to measure physical functions and symptoms in patients with upper limb musculoskeletal disorders including cubital tunnel syndrome. The QuickDASH is scored in two components: the disability/symptom section (11 items, scored 1-5) and the optional high performance sport/music or work modules (four items, scored 1-5).
Time frame: 18 months
Patient-Reported Outcomes Measurement Information System® (PROMIS®) Bank v2.1 Upper Extremity
PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS Bank v2.1 - Upper Extremity is a patient questionnaire developed to assess upper extremity physical function in patients with hand and upper extremity conditions as a separate domain from general physical function.
Time frame: 18 months
Patient-Rated Ulnar Nerve Evaluation (PRUNE)
The Patient-Rated Ulnar Nerve Evaluation (PRUNE) score is a brief, open-access, patient-reported outcome measure specifically for patients with ulnar nerve compression at the elbow that assesses pain, symptoms and functional disability.
Time frame: 18 months
Modified McGowan classification
McGowan classification grades the severity of CuTS based on patient-reported symptoms and physical examination findings.
Time frame: 18 months
12-Item Short Form Health Survey (SF-12)
The 12-Item Short Form Health Survey (SF-12) is a self-reported, health-related quality of life questionnaire assessing the impact of health on an individual's everyday life.
Time frame: 18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.