NCT01109901

Brief Summary

The purpose of this study is to determine which surgical method is better for cubital tunnel syndrome in outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 23, 2010

Completed
Last Updated

April 23, 2010

Status Verified

October 1, 2008

Enrollment Period

5 months

First QC Date

April 19, 2010

Last Update Submit

April 22, 2010

Conditions

Cubital Tunnel Syndrome

Keywords

Cubital tunnel,subcutaneous transposition,submuscular

Outcome Measures

Primary Outcomes (1)

  • Pain

    Visual Analogue Scale (VAS) with scores of zero to ten (0 for no pain and 10 intolerable pain) then scored as follows: 0, Sever (8-10); 1, Slight (4-7); 2, none (0-3)

    at 6 months post-operatively

Secondary Outcomes (3)

  • sensation

    at 6 months post-operatively

  • Muscle strength

    at 6 months post-operatively

  • Muscle atrophy

    at 6 months post-operatively

Study Arms (2)

anterior submuscular transposition

OTHER

it is kind of surgical method

Procedure: Anterior submuscular transposition

Anterior subcutaneous transposition

OTHER

it is kind of surgical method

Procedure: anterior subcutaneous transposition

Interventions

anterior subcutaneous transpositionPROCEDURE

transposition of ulnar nerve into subcutaneous bed

Also known as: ASCT
Anterior subcutaneous transposition
Anterior submuscular transpositionPROCEDURE

transposition of ulnar nerve into muscular tissue

Also known as: ASMT
anterior submuscular transposition

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with confirmed 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-zahra university hospital

Isfahan, 70007, Iran

Location

MeSH Terms

Conditions

Cubital Tunnel Syndrome

Condition Hierarchy (Ancestors)

Ulnar NeuropathiesMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesUlnar Nerve Compression SyndromesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Officials

  • hamidreza Shemshaki, MD

    MD,research comittee

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 19, 2010

First Posted

April 23, 2010

Study Start

October 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

April 23, 2010

Record last verified: 2008-10

Locations

IR(1)