Mechanomyography for Predictor of Prognosis in CuTS and PND Patients

NCT04322448 | Completed FDA Device

• 1 other identifier: 201905017
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

The study will be a non-blinded two cohort design consisting only of symptomatic patients with CuTS or compressive peroneal neuropathy or in need of peroneal nerve decompression. The first cohort will be - patients with CuTS. Evaluation of each CuTS patient will include assessment by the treating surgeon and a certified hand therapist. Patients who have clinical examination and history consistent with a diagnosis of CuTS based on subjective and functional assessment outlined below will be consented to this study. The second cohort will be patients in need PND for compressive neuropathy of peroneal nerve. PND patients will be evaluated by clinical exam and have imaging with high resolution ultrasound or MRI negative for mass lesion.

Conditions

Cubital Tunnel Syndrome; Peroneal Nerve Entrapment

Keywords

cubital tunnel; cubital; peroneal; nerve entrapment; nerve compression; nerve decompression; CuTS; PND; MMG; mechanomyography; cubital tunnel syndrome; peroneal nerve decompression

Outcome Measures

Primary Outcomes (1)

• PROMIS Questionnaire

  PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. Scores range from 0-50 with a higher indicating a better outcome.

  6 months

Secondary Outcomes (1)

• Oswestry Disability Index (ODI)

  6 months

Study Arms (2)

Cubital Tunnel Syndrome Patients

Cubital Tunnel Syndrome patients. Patients will undergo standard of care exams and surgery. During surgery, the surgeon will apply the mechanomyography (MMG) to the targeted nerve immediately prior and post decompression. Subjects will be followed until they are 6 months postop.

Device: Mechanomyography (MMG)

Peroneal Nerve Decompression Patients

Patients with compressive peroneal nerve neuropathy and will undergo a Peroneal Nerve Decompression (PND). Patients will undergo standard of care exams and surgery. During surgery, the surgeon will apply the mechanomyography (MMG) to the targeted nerve immediately prior and post decompression. Subjects will be followed until they are 6 months postop.

Device: Mechanomyography (MMG)

Interventions

Mechanomyography (MMG) DEVICE

MMG, as described in the cohort descriptions, to be used during surgery to see if they are predictive of patient outcomes.

Cubital Tunnel Syndrome Patients; Peroneal Nerve Decompression Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited in the investigator's patient population.

You may qualify if:

• Patients who have a diagnosis of Cubital Tunnel Syndrome or Compressive Peroneal Nerve Neuropathy and will be undergoing a decompressive surgery.

You may not qualify if:

• Patients under 18 years of age
• Patients who are unable to return for follow-up evaluation.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Mayo Clinic: collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Cubital Tunnel Syndrome; Peroneal Neuropathies; Nerve Compression Syndromes; Neuroma

Condition Hierarchy (Ancestors)

Ulnar Neuropathies; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Ulnar Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Wilson Z Ray, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: March 26, 2020
• Study Start: August 3, 2020
• Primary Completion: July 5, 2022
• Study Completion: February 17, 2023
• Last Updated: September 9, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)