Arthroscopic Wafer and Ulnar Shortening in Ulnar Abutment

May 26, 2017 updated by: Abd Elaziz Monsef Ali, Assiut University

Comparative Study Between Arthroscopic Wafer and Ulnar Shortening Osteotomy in Ulnar Abutment Syndrome

there are many management options of ulnocarpal abutment depends on clinical evaluation and imaging of this joint. Arthroscopic treatment is the simplest solution for these conditions.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • obvious ulnar abutment syndrome with ulnar side wrist pain

Exclusion Criteria:

  • ulnar minus or neutral variance
  • central and radial wrist pain
  • osteoarthritis of the wrist.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group 1
wafer group procedure using an arthroscope through portal(radial to extensor carpi ulnaris, debridement of triangular fibro-cartilage complex 3-4 mm is shaved from the dome of the ulna by 2.9 bur.
Procedure: wafer procedure
wrist arthroscopy and debridement of Triangular fibrocartilage and shortening of the head ulna by burr
Active Comparator: group 2
ulnar shortening group :this is the most logical technique, dorsoulnar incision is made on the distal one-third of the forearm then a 6 hole 3.5 mm Dcp plate is position,osteotomy using oscillating saw in z-shaped manner.
Procedure: arthroscopy and ulnar shortening osteotomy
wrist arthroscopy,debride debridement of Triangular fibrocartilage and shortening of the ulna by osteotomy and plate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mayo scoring system
Time Frame: 6 month
follow up of the pain( nonpain,mild occasional, moderate and sever graded as 1,2,3,4 respectively
6 month
mayo scoring system
Time Frame: 6 month
Range of motion of the wrist compared to the normal side(100 ,75-99,50-74,25-9,0-24%
6 month
mayo scoring system
Time Frame: 6 month
grip strength
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2017

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

May 16, 2017

First Submitted That Met QC Criteria

May 25, 2017

First Posted (Actual)

May 30, 2017

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 26, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • WAFER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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