Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition

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ClinicalTrials.gov Identifier: NCT01781494

Recruitment Status : Withdrawn

First Posted : February 1, 2013

Last Update Posted : December 2, 2014

Sponsor:

Information provided by (Responsible Party):

Kevin J. Renfree, Mayo Clinic

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	Not Applicable

Study Design


Study Type :	Interventional (Clinical Trial)
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 :	January 2014
Actual Primary Completion Date :	November 2014
Actual Study Completion Date :	November 2014

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Charcot-Marie-Tooth Disease Hereditary Neuropathy With Liability to Pressure Palsy Roussy Levy Syndrome

U.S. FDA Resources

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01781494

Sponsors and Collaborators

Mayo Clinic

Investigators


Principal Investigator:	Kevin Renfree, MD	Mayo Clinic

More Information


Responsible Party:	Kevin J. Renfree, Assistant Professor of Orthopedics, College of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT01781494 History of Changes
Other Study ID Numbers:	11-001012
First Posted:	February 1, 2013 Key Record Dates
Last Update Posted:	December 2, 2014
Last Verified:	November 2014

Additional relevant MeSH terms:


Cubital Tunnel Syndrome Ulnar Neuropathies Mononeuropathies Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases	Ulnar Nerve Compression Syndromes Nerve Compression Syndromes Cumulative Trauma Disorders Sprains and Strains Wounds and Injuries

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