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Trial record 15 of 55 for:    Open Studies | "Charcot-Marie-Tooth Disease"

Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Kevin J. Renfree, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01781494
First received: January 29, 2013
Last updated: May 13, 2014
Last verified: May 2014
  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
Endpoint Classification: Efficacy Study
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:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in the distance between the ligaclips on lateral elbow radiographs [ Time Frame: Baseline to 3 months post-operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Isokinetic strength testing of elbow flexion, forearm pronation, and wrist flexion [ Time Frame: Baseline to 3 months post-operatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: January 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: December 2015 (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
Genders Eligible for Study:   Both
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

Contacts
Contact: Andre Watkins 480-342-0349 watkins.andre@mayo.edu

Locations
United States, Arizona
Mayo Clinic in Arizona Not yet recruiting
Phoenix, Arizona, United States, 85054
Contact: Andre Watkins    480-342-0349    watkins.andre@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Kevin Renfree, MD Mayo Clinic
  More Information

No publications provided

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: May 13, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 25, 2014