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Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition

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Mayo Clinic

Status

Withdrawn

Conditions

Cubital Tunnel Syndrome

Treatments

Procedure: Immobilization followed by protected range of motion
Procedure: Immediate range of motion

Study type

Interventional

Funder types

Other

Identifiers

NCT01781494
11-001012

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Immobilization
Active Comparator group
Description:
Immobilization followed by protected range of motion
Treatment:
Procedure: Immobilization followed by protected range of motion
Immediate range of motion
Experimental group
Description:
Immediate motion after anterior submuscular ulnar nerve transposition
Treatment:
Procedure: Immediate range of motion

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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