Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition
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ClinicalTrials.gov Identifier: NCT01781494 |
Recruitment Status
:
Withdrawn
First Posted
: February 1, 2013
Last Update Posted
: December 2, 2014
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cubital Tunnel Syndrome | Procedure: Immobilization followed by protected range of motion Procedure: Immediate range of motion | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition: Affect on Flexor-pronator Integrity |
Study Start Date : | January 2014 |
Actual Primary Completion Date : | November 2014 |
Actual Study Completion Date : | November 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Immobilization
Immobilization followed by protected range of motion
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Procedure: Immobilization followed by protected range of motion |
Experimental: Immediate range of motion
Immediate motion after anterior submuscular ulnar nerve transposition
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Procedure: Immediate range of motion |
- Change in the distance between the ligaclips on lateral elbow radiographs [ Time Frame: Baseline to 3 months post-operatively ]
- Isokinetic strength testing of elbow flexion, forearm pronation, and wrist flexion [ Time Frame: Baseline to 3 months post-operatively ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01781494
Principal Investigator: | Kevin Renfree, MD | Mayo Clinic |
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 |
First Posted: | February 1, 2013 Key Record Dates |
Last Update Posted: | December 2, 2014 |
Last Verified: | November 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 |