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

NCT01893164 | Unknown DMC

• 1 other identifier: JilinU-218-RLi
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cubital Tunnel Syndrome

Keywords

cubital tunnel syndrome; simple decompression; anterior subcutaneous transposition of ulnar nerve; anterior intramuscular transposition of ulnar nerve; severity scale

Outcome Measures

Primary Outcomes (1)

• sensation

  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.

  at 6 months post-operatively

Secondary Outcomes (3)

• Muscle strength

  at 6 months post-operatively

• pain

  at 6 months post-operatively

• electromyography

  at 6 months post-operatively

Study Arms (2)

moderate cubital tunnel syndrome

EXPERIMENTAL

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.

Procedure: simple decompression; Procedure: anterior subcutaneous transposition; Procedure: anterior intramuscular transposition

severe cubital tunnel syndrome

EXPERIMENTAL

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.

Procedure: simple decompression; Procedure: anterior subcutaneous transposition; Procedure: anterior intramuscular transposition

Interventions

simple decompression PROCEDURE

decompression of the ulnar nerve

Also known as: SDP

moderate cubital tunnel syndrome; severe cubital tunnel syndrome

anterior subcutaneous transposition PROCEDURE

transposition of the ulnar nerve into subcutaneous bed

Also known as: ASCT

moderate cubital tunnel syndrome; severe cubital tunnel syndrome

anterior intramuscular transposition PROCEDURE

transposition of the ulnar nerve into muscular tissue

Also known as: AIMT

moderate cubital tunnel syndrome; severe cubital tunnel syndrome

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jilin University: lead

Study Sites (1)

Hand Surgery Department of China-Japan Union Hospital

Changchun, Jilin, 130000, China

RECRUITING

MeSH Terms

Conditions

Cubital Tunnel Syndrome

Condition Hierarchy (Ancestors)

Ulnar Neuropathies; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Ulnar Nerve Compression Syndromes; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Rui Li, chief doctor

  Hand Sugery Department of the China-Japan Union Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief doctor and PhD supervisor

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 8, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 8, 2013

Record last verified: 2013-07

Locations

CN (1)