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STUDY PROTOCOL
Year : 2016  |  Volume : 1  |  Issue : 1  |  Page : 15-21

Cubital tunnel syndrome treated with ulnar nerve simple decompression, anterior intramuscular or subcutaneous transposition: a parallel randomized controlled clinical trial


Center for Hand and Foot Surgery and Reparative and Reconstructive Surgery, Orthopedics Hospital, the Second Hospital, Jilin University, Changchun, Jilin Province, China

Correspondence Address:
Rui Li
Center for Hand and Foot Surgery and Reparative and Reconstructive Surgery, Orthopedics Hospital, the Second Hospital, Jilin University, Changchun, Jilin Province
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2468-5674.178845

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Background: Simple decompression and anterior transposition of the ulnar nerve are surgical methods commonly used for treating moderate and severe cubital tunnel syndrome. It is generally thought that anterior transposition effectively eliminates ulnar nerve compression, but simple decompression cannot improve symptoms. However, studies have also shown that the therapeutic effects of the two procedures are identical. The advantages and disadvantages of the two surgical methods have been described in a small number of cases. Thus, we will conduct a parallel-group randomized controlled clinical trial to determine the optimal surgical intervention. Methods/Design: The trial will be conducted at the Center for Hand and Foot Surgery and Reparative and Reconstructive Surgery, Orthopedics Hospital, the Second Hospital, Jilin University, China. Moderate and severe cubital tunnel syndrome patients will be equally and randomly divided into simple decompression, anterior intramuscular transposition, and anterior subcutaneous transposition groups. In the simple decompression group, adhesions will be completely removed around the ulnar nerve. In the anterior intramuscular transposition group, the ulnar nerve and its accompanying nutrient vessels will be removed in the tunnel of the forearm flexor, pronator teres muscle membrane, and a small portion of muscle fibers below it. In the anterior subcutaneous transposition group, the ulnar nerve in the cubital tunnel will be dissociated and placed in the subcutaneous tissue of the forearm flexor and pronator teres. Two primary outcomes will be determined, sensory disturbance, tested with Semmes-Weinstein filaments, and muscle strength, evaluated using the Medical Research Council's grading system. The secondary outcomes of pain will be assessed with the Visual Analogue Scale and the function of the ulnar nerve with electromyography. Discussion: Trial results will provide a reference for selecting an effective surgical method for treating moderate and severe cubital tunnel syndrome. Trial registration: ClinicalTrial.gov identifier: NCT01893164; registered on 2 July 2013. Ethical approval: Written approval for this project was obtained from the Ethics Committee of the Orthopedics Hospital, the Second Hospital, Jilin University of China. Our study is in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association.


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