Simple Decompression Versus Anterior Transposition of the Ulnar Nerve

Not Applicable

Completed

• Conditions: Humeral Fractures; Ulnar Nerve Compression
• Interventions: Procedure: anterior subcutaneous transposition; Procedure: Simple decompression

• Registration Number: NCT01051869
• Lead Sponsor: Unity Health Toronto

Brief Summary

Both simple decompression and anterior transposition of the elbow nerve (ulnar nerve) for acute displaced fractures of the elbow (distal humerus) treated with plate fixation are currently used by surgeons. We want to examine which treatment will overall give better results in regards to arm function and residual pain.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-18
• Study First Submitted QC: 2010-01-19
• Study First Posted: 2010-01-20
• Study Start: 2010-09
• Primary Completion: 2018-09
• Study Completion: 2019-09
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-23
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Men or women aged 16 to 60 years of age
• Displaced, distal humerus fracture (OTA 13A or 13C) as seen in radiographs
• Fractures ≤ 28 days post injury
• Closed fractures
• No history of previous ulnar neuropathy or elbow pathology
• Provisin of informed consent

Exclusion Criteria

• Vascular injury
• History of previous ulnar neuropathy or elbow pathology
• Fractures more than 28 days post-injury
• Limited life expectancy due to significant medical co-morbidity or medical contraindication to surgery
• Inability to comply with rehabilitation or form completion
• Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anterior subcutaneous transposition	anterior subcutaneous transposition	-
simple decompression	Simple decompression	-

Primary Outcome Measures

Name	Time	Method
The primary outcome will be signs of ulnar neuropathy, measured using two clinical staging systems to assess the degree of dysfunction of the ulnar nerve (the classification system of Gabel and Amadio13).	1 Year

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measurement will include a patient-oriented, limb-specific, functional measurement questionnaire (Disabilities of the Arm, Shoulder and Hand Instrument-DASH)	1 Year

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada