Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition

Study Overview
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Brief Summary
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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.

Official Title
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Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition: Affect on Flexor-pronator Integrity

Conditions
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Cubital Tunnel Syndrome

Intervention / Treatment
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* Procedure: Immobilization followed by protected range of motion
* Procedure: Immediate range of motion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immobilization<br>Immobilization followed by protected range of motion | Procedure: Immobilization followed by protected range of motion<br> <br> |
| Experimental: Immediate range of motion<br>Immediate motion after anterior submuscular ulnar nerve transposition | Procedure: Immediate range of motion<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the distance between the ligaclips on lateral elbow radiographs |  | Baseline to 3 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isokinetic strength testing of elbow flexion, forearm pronation, and wrist flexion |  | Baseline to 3 months post-operatively |