Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition

This study has been withdrawn prior to enrollment.

Sponsor:

Information provided by (Responsible Party):

Kevin J. Renfree, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT01781494

First received: January 29, 2013

Last updated: November 26, 2014

Last verified: November 2014

History of Changes

Purpose

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	Intervention
Cubital Tunnel Syndrome	Procedure: Immobilization followed by protected range of motion Procedure: Immediate range of motion


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition: Affect on Flexor-pronator Integrity

Resource links provided by NLM:

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

Further study details as provided by Kevin J. Renfree, Mayo Clinic:

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 ]


Enrollment:	0
Study Start Date:	January 2014
Study Completion Date:	November 2014
Primary Completion Date:	November 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	January 29, 2013
Last Updated:	November 26, 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

ClinicalTrials.gov processed this record on July 19, 2017

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