Simple Decompression Versus Anterior Transposition of the Ulnar Nerve

Study Overview
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Brief Summary
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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.

Official Title
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A Multicentre, Randomized Trial of Simple Decompression Versus Anterior Transposition of the Ulnar Nerve for Acute, Displaced Fractures of the Distal Humerus Treated With Plate Fixation

Conditions
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Humeral Fractures, Ulnar Nerve Compression

Intervention / Treatment
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* Procedure: Simple decompression
* Procedure: anterior subcutaneous transposition


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: simple decompression<br> | Procedure: Simple decompression<br>* Fracture fixation will be performed through a posterior approach, as this provides excellent visualization of the distal fragments. A triceps split will be used to expose the distal humerus. A midline incision will be made from proximally to distal onto the shaft of the ulna. Equal portions of the triceps muscle will be reflected medially and laterally, with use of sharp dissection to remove the triceps insertion from the olecranon. The ulnar nerve will be identified and protected proximal and distal to the medial epicondyle. Fracture fixation will be performed after anatomic reduction using standard fixation techniques and plate fixation on both the medial and lateral column. In the simple ulnar nerve decompression group, no further treatment of the ulnar nerve will be undertaken.<br>|
| Active Comparator: anterior subcutaneous transposition<br> | Procedure: anterior subcutaneous transposition<br>* In the anterior transposition of the ulnar nerve group, the ulnar nerve will be placed subcutaneously anterior to the medial epicondyle free from any pressure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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distal humerus, fractures, ulnar nerve, simple decompression, anterior transposition