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Biomechanical Evaluation of Wrist Ligament Injuries: Diagnostic Tool to Detect Wrist Instability

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00657072
First Posted: April 14, 2008
Last Update Posted: November 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by:
State University of New York - Upstate Medical University
  Purpose

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.


Condition
Scapholunate Interosseous Ligament Torn Wrist Ligaments

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Biomechanical Evaluation of Wrist Ligament Injuries: Diagnostic Tool to Detect Wrist Instability

Further study details as provided by State University of New York - Upstate Medical University:

Estimated Enrollment: 50
Study Start Date: May 2003
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who have suffered ligamentous injuries to their wrists will be recruited for this study
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00657072


Locations
United States, New York
SUNY Upstate Medical University, Musculoskeletal Science Research Center
Syracuse, New York, United States, 13210
Sponsors and Collaborators
State University of New York - Upstate Medical University
National Institutes of Health (NIH)
Investigators
Principal Investigator: Walter H Short, MD State University of New York - Upstate Medical University
  More Information

Responsible Party: Walter H. Short, M.D., SUNY Upstate Medical University
ClinicalTrials.gov Identifier: NCT00657072     History of Changes
Other Study ID Numbers: 4840
1R01AR050099 ( U.S. NIH Grant/Contract )
First Submitted: April 8, 2008
First Posted: April 14, 2008
Last Update Posted: November 23, 2015
Last Verified: November 2015

Keywords provided by State University of New York - Upstate Medical University:
scapholunate instability
neural networks
scaphoid
lunate
Suspected torn scapholunate interosseous ligament
Suspected other torn wrist ligaments