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Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition

NCT ID: NCT01781494

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-11-30

Brief Summary

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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

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Conditions

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Cubital Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immobilization

Immobilization followed by protected range of motion

Group Type ACTIVE_COMPARATOR

Immobilization followed by protected range of motion

Intervention Type PROCEDURE

Immediate range of motion

Immediate motion after anterior submuscular ulnar nerve transposition

Group Type EXPERIMENTAL

Immediate range of motion

Intervention Type PROCEDURE

Interventions

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Immobilization followed by protected range of motion

Intervention Type PROCEDURE

Immediate range of motion

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Kevin J. Renfree

Assistant Professor of Orthopedics, College of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kevin Renfree, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Other Identifiers

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11-001012

Identifier Type: -

Identifier Source: org_study_id