Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition

NCT01781494 | Withdrawn

• 1 other identifier: 11-001012
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cubital Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in the distance between the ligaclips on lateral elbow radiographs

  Baseline to 3 months post-operatively

Secondary Outcomes (1)

• Isokinetic strength testing of elbow flexion, forearm pronation, and wrist flexion

  Baseline to 3 months post-operatively

Study Arms (2)

Immobilization

ACTIVE COMPARATOR

Immobilization followed by protected range of motion

Procedure: Immobilization followed by protected range of motion

Immediate range of motion

EXPERIMENTAL

Immediate motion after anterior submuscular ulnar nerve transposition

Procedure: Immediate range of motion

Interventions

Immobilization followed by protected range of motion PROCEDURE

Immobilization

Immediate range of motion PROCEDURE

Immediate range of motion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Candidates for anterior submuscular ulnar nerve transposition based on history, positive findings on physical examination, and confirmatory electrodiagnostic testing in Mayo Clinic Arizona

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

MeSH Terms

Conditions

Cubital Tunnel Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Kevin Renfree, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopedics, College of Medicine

Study Record Dates

• First Submitted: January 29, 2013
• First Posted: February 1, 2013
• Study Start: January 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-11