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Clinical Trials/NCT01893164
NCT01893164
Unknown
Not Applicable

Comparison of Simple Decompression Versus Anterior Subcutaneous and Intramuscular Transposition of the Ulnar Nerve for Moderate and Severe Cubital Tunnel Syndrome :A Randomized Double-blind Control Trial

Jilin University1 site in 1 country144 target enrollmentJuly 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cubital Tunnel Syndrome
Sponsor
Jilin University
Enrollment
144
Locations
1
Primary Endpoint
sensation
Last Updated
12 years ago

Overview

Brief Summary

The purpose of this study is to determine which is the best surgery to treat different severity scales of cubital tunnel syndrome.

Detailed Description

The purpose of this study is to determine which one of the simple decompression,anterior subcutaneous and intramuscular transposition of the ulnar nerve has the best outcomes for moderate and severe cubital tunnel syndrome.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
October 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Jilin University
Responsible Party
Principal Investigator
Principal Investigator

Rui Li

chief doctor and PhD supervisor

Jilin University

Eligibility Criteria

Inclusion Criteria

  • patients with confirmed cubital tunnel syndrome
  • moderate and severe cubital tunnel syndrome.

Exclusion Criteria

  • Significant cervical spine and shoulder disease
  • deformity or distortion of the cubital tunnel due to previous trauma to elbow
  • recurrent cubital tunnel syndrome after previous surgery
  • mild cubital tunnel syndrome.

Outcomes

Primary Outcomes

sensation

Time Frame: at 6 months post-operatively

Sensory disturbance were tested with Semmes-Weinstein filaments and sensory deficits were categorized according to the Yale sensory scale. According to standard scoring system that designed, the severity of sensation and function of the ulnar nerve was scored as follows: ---- 0, Abscent sensation; 1, Decrease or abnormal sensation; 2, Intact sensation.

Secondary Outcomes

  • Muscle strength(at 6 months post-operatively)
  • pain(at 6 months post-operatively)
  • electromyography(at 6 months post-operatively)

Study Sites (1)

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