Comparison of Different Surgical Treatments for Different Scales of Cubital Tunnel Syndrome

NCT ID: NCT01893164

Last Updated: 2013-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Cubital Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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moderate cubital tunnel syndrome

Sensory,Intermittent paresthesias; vibratory perception normal or decreasedMotor,Measurable weakness in pinch or grip strengthTests,Elbow flexion test or Tinel's sign is positive; finger crossing may be abnormal.Treated by simple decompression,anterior subcutaneous transposition and anterior intramuscular transposition of the ulnar nerve.

Group Type EXPERIMENTAL

simple decompression

Intervention Type PROCEDURE

decompression of the ulnar nerve

anterior subcutaneous transposition

Intervention Type PROCEDURE

transposition of the ulnar nerve into subcutaneous bed

anterior intramuscular transposition

Intervention Type PROCEDURE

transposition of the ulnar nerve into muscular tissue

severe cubital tunnel syndrome

Sensory,Persistent paresthesias; vibratory perception decreased; abnormal two-point discrimination(static \>6 mm, moving \>4 mm)Motor,Measurable weakness in pinch and grip plus muscle atrophyTests,Positive elbow flexion test or positive Tinel's sign may be present; finger crossing usually abnormal.Treated by simple decompression,anterior subcutaneous transposition and anterior intramuscular transposition of the ulnar nerve.

Group Type EXPERIMENTAL

simple decompression

Intervention Type PROCEDURE

decompression of the ulnar nerve

anterior subcutaneous transposition

Intervention Type PROCEDURE

transposition of the ulnar nerve into subcutaneous bed

anterior intramuscular transposition

Intervention Type PROCEDURE

transposition of the ulnar nerve into muscular tissue

Interventions

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simple decompression

decompression of the ulnar nerve

Intervention Type PROCEDURE

anterior subcutaneous transposition

transposition of the ulnar nerve into subcutaneous bed

Intervention Type PROCEDURE

anterior intramuscular transposition

transposition of the ulnar nerve into muscular tissue

Intervention Type PROCEDURE

Other Intervention Names

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SDP ASCT AIMT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jilin University

OTHER

Sponsor Role lead

Responsible Party

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Rui Li

chief doctor and PhD supervisor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rui Li, chief doctor

Role: STUDY_CHAIR

Hand Sugery Department of the China-Japan Union Hospital

Locations

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Hand Surgery Department of China-Japan Union Hospital

Changchun, Jilin, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Rui Li, chief doctor

Role: primary

13304321102

Other Identifiers

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JilinU-218-RLi

Identifier Type: -

Identifier Source: org_study_id

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