Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition
Primary Purpose
Cubital Tunnel Syndrome
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Immobilization followed by protected range of motion
Immediate range of motion
Sponsored by
About this trial
This is an interventional treatment trial for Cubital Tunnel Syndrome
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Immobilization
Immediate range of motion
Arm Description
Immobilization followed by protected range of motion
Immediate motion after anterior submuscular ulnar nerve transposition
Outcomes
Primary Outcome Measures
Change in the distance between the ligaclips on lateral elbow radiographs
Secondary Outcome Measures
Isokinetic strength testing of elbow flexion, forearm pronation, and wrist flexion
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01781494
Brief Title
Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition
Official Title
Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition: Affect on Flexor-pronator Integrity
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Withdrawn
Study Start Date
January 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cubital Tunnel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immobilization
Arm Type
Active Comparator
Arm Description
Immobilization followed by protected range of motion
Arm Title
Immediate range of motion
Arm Type
Experimental
Arm Description
Immediate motion after anterior submuscular ulnar nerve transposition
Intervention Type
Procedure
Intervention Name(s)
Immobilization followed by protected range of motion
Intervention Type
Procedure
Intervention Name(s)
Immediate range of motion
Primary Outcome Measure Information:
Title
Change in the distance between the ligaclips on lateral elbow radiographs
Time Frame
Baseline to 3 months post-operatively
Secondary Outcome Measure Information:
Title
Isokinetic strength testing of elbow flexion, forearm pronation, and wrist flexion
Time Frame
Baseline to 3 months post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Renfree, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition
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