Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition

Not Applicable

Withdrawn

• Conditions: Cubital Tunnel Syndrome
• Interventions: Procedure: Immobilization followed by protected range of motion; Procedure: Immediate range of motion

• Registration Number: NCT01781494
• Lead Sponsor: Mayo Clinic

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 Description

Not available

Study Timeline

• Study First Submitted: 2013-01-29
• Study First Submitted QC: 2013-01-30
• Study First Posted: 2013-02-01
• Study Start: 2014-01
• Status Verified: 2014-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-26
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Candidates for anterior submuscular ulnar nerve transposition based on history, positive findings on physical examination, and confirmatory electrodiagnostic testing in Mayo Clinic Arizona

Exclusion criteria:

• Pregnancy
• Patients who have had prior ulnar nerve surgery
• Patients with other documented neurogenic processes identified on electrodiagnostic studies (ie: peripheral neuropathy, cervical radiculopathy, carpal tunnel syndrome)
• Workman's compensation patients
• Subluxing ulnar nerve
• Elbow contracture or stiffness
• Negative electrodiagnostic studies

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immobilization	Immobilization followed by protected range of motion	Immobilization followed by protected range of motion
Immediate range of motion	Immediate range of motion	Immediate motion after anterior submuscular ulnar nerve transposition

Primary Outcome Measures

Name	Time	Method
Change in the distance between the ligaclips on lateral elbow radiographs	Baseline to 3 months post-operatively

Secondary Outcome Measures

Name	Time	Method
Isokinetic strength testing of elbow flexion, forearm pronation, and wrist flexion	Baseline to 3 months post-operatively