A Clinical Trial for Surgery of the Ulnar Nerve (SUN) at the Elbow

University Of Michigan At Ann Arbor, Ann Arbor MI

Investigators

Abstract

? DESCRIPTION (provided by applicant): Ulnar neuropathy at the elbow is a common compressive neuropathy that results in considerable discomfort and disability. Surgery is usually recommended when conservative treatment is not effective. However, there is an ongoing debate among physicians as to the best surgical procedure to treat this condition. The two most common procedures, simple decompression and anterior subcutaneous transposition, have been studied in several randomized controlled trials, systematic reviews, and meta-analyses. Currently, no studies have found a significant difference in outcomes between these two procedures. The difficulty in comparing these two procedures is compounded by the lack of a standardized method to assess outcomes. We are proposing to randomize patients at 13 medical centers who are diagnosed with ulnar neuropathy to treatment with either simple decompression or anterior subcutaneous transposition. Subjects will be assessed before surgery and at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after surgery. Assessments will include validated patient-rated outcome questionnaires and functional outcomes. This study will compare the outcomes, trend of recovery, and complications between simple decompression and anterior subcutaneous transposition. Based on the study results, we plan to develop a treatment algorithm that determines the best procedure for patients based on patient characteristics and severity of disease.