Clinical Trial: Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition: Affect on Flexor-pronator Integrity

Brief Summary:

The goal of this study is to test the hypothesis that immediate elbow motion is safe after anterior submuscular ulnar nerve transposition, and will not result in disruption of the repaired flexor pronator origin, under which the nerve is placed. The advantages of immediate elbow motion after submuscular ulnar nerve transposition for performing activities of daily living and self-care are evident, however theoretical advantages include early "gliding" of the transposed ulnar nerve with a lower risk of nerve adhesions and subsequent traction neuritis, as well as improved blood flow and quicker, more complete, recovery of nerve function.

A group of 44 consecutive patients that are determined to be candidates for anterior submuscular ulnar nerve transposition based on history, positive findings on physical examination, and confirmatory electrodiagnostic testing will be prospectively randomized to either immediate motion or long arm cast immobilization after surgery. All patients will be counseled about the two postoperative treatment options (immobilization followed by protected range of motion versus immediate range of motion), risks involved with each treatment protocol, postoperative follow-up and need for radiographs. If they choose not to participate, they will be treated by the same postoperative protocol currently used by the principal investigator: arm sling at rest for six weeks with intermittent active assisted range of motion exercises.

Detailed Summary:
Sponsor: Mayo Clinic

Current Primary Outcome: Change in the distance between the ligaclips on lateral elbow radiographs [ Time Frame: Baseline to 3 months post-operatively ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Isokinetic strength testing of elbow flexion, forearm pronation, and wrist flexion [ Time Frame: Baseline to 3 months post-operatively ]

Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: January 29, 2013
Date Started: January 2014
Date Completion:
Last Updated: November 26, 2014
Last Verified: November 2014