Simple Decompression Versus Anterior Transposition of the Ulnar Nerve
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|ClinicalTrials.gov Identifier: NCT01051869|
Recruitment Status : Completed
First Posted : January 20, 2010
Last Update Posted : September 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Humeral Fractures Ulnar Nerve Compression||Procedure: Simple decompression Procedure: anterior subcutaneous transposition||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||September 2018|
|Actual Study Completion Date :||September 2018|
|Active Comparator: simple decompression||
Procedure: Simple decompression
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.
|Active Comparator: anterior subcutaneous transposition||
Procedure: anterior subcutaneous transposition
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.
- 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). [ Time Frame: 1 Year ]
- Secondary outcome measurement will include a patient-oriented, limb-specific, functional measurement questionnaire (Disabilities of the Arm, Shoulder and Hand Instrument-DASH) [ Time Frame: 1 Year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01051869
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5C 1R6|
|Principal Investigator:||Emil H Schemitsch, MD, FRCS(C)||St. Michael's Hospital, Toronto|