Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition

Cubital Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01781494
• Other study ID #: 11-001012
• Status: Withdrawn
• Phase: N/A
• First received: January 29, 2013
• Last updated: November 26, 2014
• Start date: January 2014
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cubital Tunnel Syndrome

Intervention

Procedure:
• Immobilization followed by protected range of motion

• Immediate range of motion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the distance between the ligaclips on lateral elbow radiographs		Baseline to 3 months post-operatively	No
Secondary	Isokinetic strength testing of elbow flexion, forearm pronation, and wrist flexion		Baseline to 3 months post-operatively	No