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NCT00657072 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by State University of New York - Upstate Medical University.

Completed
Registry status
50
Enrollment target

NCT00657072: Completed study, sponsored by State University of New York - Upstate Medical University.

NCT00657072 is a clinical trial that has completed, run by State University of New York - Upstate Medical University. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00657072 has completed, sponsored by State University of New York - Upstate Medical University.

COMPLETED
Registry status
50 participants
Enrollment target

Study Summary

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.

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2003-05
Est. Completion 2008-10

What the finished NCT00657072 record still lists

NCT00657072 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT00657072 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00657072 about?

NCT00657072 is a clinical study titled "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 anim...

What is the current status of trial NCT00657072?

This trial is currently completed. The enrollment target is 50 participants. The study started on 2003-05. Estimated completion is 2008-10.

Who is sponsoring clinical trial NCT00657072?

This trial is sponsored by State University of New York - Upstate Medical University, which has 113 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00657072, the US trial registry maintained by the National Library of Medicine. NCT00657072 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.