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Clinical Trial Summary

The purpose of this study is to document the performance and clinical outcomes of uncemented total elbow replacements involving the press-fit technique performed at the Vanderbilt Hand Center. The press-fit use technique is often used because of complications with cement loosening.


Clinical Trial Description

The three parts of this study will be:

Retrospective Chart Review-

A chart review will be completed on all patients that have had an uncemented total elbow arthroplasty using the press-fit technique at Vanderbilt Hand & Upper Extremity Center. The chart review will include:

- A historical data form

- An operative data form

- A radiographic assessment form

Questionnaire Mailing- We will mail prospective study patients a DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire to complete with a mailing letter explaining the request for this information. The DASH will be modified to ask patients regarding their pre-operative time as well.

Clinical Data Collection-

We will enroll patients who have already had/or will be having a uncemented total elbow arthroplasty using the press-fit technique. If the patient already has a file completed through the chart review we will not complete the historical data form, operative form, or previous radiograph assessments. If the patient does not have a file completed through the chart review the data collection will include:

- An Informed Consent Document

- A historical data form

- An operative data form

- A radiographic assessment form

- Patient-completed DASH questionnaire

- Elbow Assessment Form ;


Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT00974298
Study type Observational
Source Vanderbilt University
Contact
Status Terminated
Phase N/A
Start date March 2009
Completion date December 2013

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05180071 - A Post-market Study Evaluating Clinical and Radiographic Outcomes of Total Elbow Arthroplasty With TEMA N/A