Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition

Sponsor

Mayo Clinic (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01781494

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cubital Tunnel Syndrome	Procedure: Immobilization followed by protected range of motion Procedure: Immediate range of motion	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Immobilization Immobilization followed by protected range of motion	Procedure: Immobilization followed by protected range of motion
Experimental: Immediate range of motion Immediate motion after anterior submuscular ulnar nerve transposition	Procedure: Immediate range of motion

Arm

Intervention/Treatment

Active Comparator: Immobilization

Immobilization followed by protected range of motion

Procedure: Immobilization followed by protected range of motion

Experimental: Immediate range of motion

Immediate motion after anterior submuscular ulnar nerve transposition

Procedure: Immediate range of motion

Outcome Measures

Primary Outcome Measures

Change in the distance between the ligaclips on lateral elbow radiographs [Baseline to 3 months post-operatively]

Secondary Outcome Measures

Isokinetic strength testing of elbow flexion, forearm pronation, and wrist flexion [Baseline to 3 months post-operatively]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Kevin Renfree, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kevin J. Renfree, Assistant Professor of Orthopedics, College of Medicine, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT01781494

Other Study ID Numbers:

11-001012

First Posted:

Feb 1, 2013

Last Update Posted:

Dec 2, 2014

Last Verified:

Nov 1, 2014

Additional relevant MeSH terms:

Cubital Tunnel Syndrome

Study Results

No Results Posted as of Dec 2, 2014