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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Recruitment Status : Withdrawn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
Sponsor:
Information provided by (Responsible Party):
Kevin J. Renfree, Mayo Clinic

January 29, 2013
February 1, 2013
December 2, 2014
January 2014
November 2014   (Final data collection date for primary outcome measure)
Change in the distance between the ligaclips on lateral elbow radiographs [ Time Frame: Baseline to 3 months post-operatively ]
Same as current
Complete list of historical versions of study NCT01781494 on ClinicalTrials.gov Archive Site
Isokinetic strength testing of elbow flexion, forearm pronation, and wrist flexion [ Time Frame: Baseline to 3 months post-operatively ]
Same as current
Not Provided
Not Provided
 
Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition
Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition: Affect on Flexor-pronator Integrity

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cubital Tunnel Syndrome
  • Procedure: Immobilization followed by protected range of motion
  • Procedure: Immediate range of motion
  • Active Comparator: Immobilization
    Immobilization followed by protected range of motion
    Intervention: Procedure: Immobilization followed by protected range of motion
  • Experimental: Immediate range of motion
    Immediate motion after anterior submuscular ulnar nerve transposition
    Intervention: Procedure: Immediate range of motion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
44
November 2014
November 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01781494
11-001012
No
Not Provided
Not Provided
Kevin J. Renfree, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Kevin Renfree, MD Mayo Clinic
Mayo Clinic
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP