Health-Related Quality of Life in Cases of Cubital Tunnel Syndrome

NCT02995382 | Withdrawn

• 1 other identifier: 2016-2361
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to determine the Health Related Quality of life (HRQOL) (the physical, mental, emotional and social functioning) of patients with cubital tunnel syndrome following anterior intramuscular transposition, after one year.

Conditions

Cubital Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• Is there improvement in Health Related Quality of Life?

  HRQOL will be determined using 3 questionnaires: a generic widely reported scale (SF-36), a condition specific valid and reliable scale (The PRUNE), and a utility scale EuroQol-5D)

  1 week and 1 day pre-op & 3, 6, 12 months post op

Secondary Outcomes (2)

• Which Domains of Health Related Quality of Life Improve?

  1 week and 1 day pre-op & 3, 6, 12 months post op

• Is there improvement in physical performance?

  1 week and 1 day pre-op & 3, 6, 12 months post op

Study Arms (1)

Anterior Intramuscular Transposition

EXPERIMENTAL

This is the only arm in our study, patients with cubital tunnel syndrome will undergo anterior intramuscular transposition, one of many surgical techniques utilized on patients with Cubital Tunnel Syndrome to alleviate symptoms.

Procedure: Anterior Intramuscular Transposition

Interventions

Anterior Intramuscular Transposition PROCEDURE

Anterior intramuscular transposition technique to decompress the ulnar nerve at the level of the elbow

Anterior Intramuscular Transposition

Eligibility Criteria

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

You may qualify if:

• Diagnosis of cubital tunnel syndrome confirmed with Electromyography (EMG) testing or Ultrasound imaging
• Ability to comprehend English and complete health related quality of life questionnaires
• Willing to provide informed consent
• Age \> 18 years
• Not pregnant

You may not qualify if:

• Prior ipsilateral cubital tunnel release
• Evidence of symptomatic clinical double crush syndrome confirmed by EMG/Nerve Conduction Study (NCS)
• Patients with rheumatoid arthritis, connective tissue disorder, tenosynovitis, or diagnosed neurological condition that could confound the assessment of health-related quality of life with regard to the affected arm and hand

Sponsors & Collaborators

• McMaster University: lead

MeSH Terms

Conditions

Cubital Tunnel Syndrome

Condition Hierarchy (Ancestors)

Ulnar Neuropathies; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Ulnar Nerve Compression Syndromes; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Matthew McRae, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 16, 2016
• Study Start: April 1, 2023
• Primary Completion: April 1, 2023
• Study Completion: June 1, 2023
• Last Updated: July 21, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share