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Biomechanical Evaluation of Wrist Ligament Injuries: Diagnostic Tool to Detect Wrist Instability
This study is enrolling participants by invitation only.
Study NCT00657072   Information provided by State University of New York - Upstate Medical University
First Received: April 8, 2008   Last Updated: July 28, 2008   History of Changes

April 8, 2008
July 28, 2008
May 2003
 
 
 
Complete list of historical versions of study NCT00657072 on ClinicalTrials.gov Archive Site
 
 
 
Biomechanical Evaluation of Wrist Ligament Injuries: Diagnostic Tool to Detect Wrist Instability
Biomechanical Evaluation of Wrist Ligament Injuries: Diagnostic Tool to Detect Wrist Instability

Damage to the ligaments of the wrist occurs frequently, however, it is not well publicized or understood. Our previous and current biomechanical studies have shown that damage to certain wrist ligaments is the likely cause of wrist instability and pain. Based on our three dimensional models and animations of actual cadaver motions with various ligaments intact or sectioned, we have identified several changes in how the carpal bones move and are positioned relative to the radius with various levels of instability. Using this information, we have developed a mathematical model that can predict in cadaver wrists which groups of ligaments have been injured. We started, under IRB approval, a prospective clinical study to evaluate the reliability of this mathematical model. During the past 5 years we have studied 13 patients with suspected wrist ligament injuries who were previously scheduled for surgical treatment. CT scans have been performed of the injured wrist and for comparison purposes, the contralateral, uninjured wrist. During these 5 years, there were no problems with the conduct of the study. During these 5 years the only changes to the original study application were

  • a) to include a CT scan of the contralateral wrist for comparison purposes
  • b) a paper handout given to potential subjects
  • c) to add additional people to the study team.

The principal investigator, blinded to the results of the CT scan, surgically explores and treats these patients in the same manner that he would for any patient with suspected wrist ligament injuries. During the surgery, the investigator determines the integrity of the various wrist ligaments. The prediction of which ligaments are damaged, based upon the CT scan information and mathematical model is compared to the actual surgical findings. The importance of this study is to develop a tool that will allow one to rapidly and non invasively diagnose wrist instability and initiate treatment before further damage is done.

 
 
Observational
Case-Only, Prospective
  • Scapholunate Interosseous Ligament
  • Torn Wrist Ligaments
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Enrolling by invitation
50
May 2010
 

Inclusion Criteria:

  • patients who have suffered ligamentous injuries to their wrists and have been referred to the principal investigator
  • subject selected to undergo surgery
  • The ethnicity and racial makeup of the group is similar to the demographics of the surrounding referral base
  • There will be no exclusion of any gender, racial or ethnic group

Exclusion Criteria:

  • Pregnant women will not be included because of increased anesthetic risks at surgery.
Both
16 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00657072
Walter H. Short, M.D., SUNY Upstate Medical University
4840, 1R01AR050099
State University of New York - Upstate Medical University
National Institutes of Health (NIH)
Principal Investigator: Walter H Short, MD State University of New York - Upstate Medical University
State University of New York - Upstate Medical University
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP