Clinical Trials Directory

Trials / Terminated

TerminatedNCT00974298

Uncemented Total Elbow Arthroplasty Data Collection

Status
Terminated
Phase
Study type
Observational
Enrollment
2 (actual)
Sponsor
Vanderbilt University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed 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

Conditions

Interventions

TypeNameDescription
PROCEDURETotal elbow replacement arthroplastyTotal elbow arthroplasty using pressfit technique in which no cement is used.

Timeline

Start date
2009-03-01
Primary completion
2013-12-01
Completion
2013-12-01
First posted
2009-09-10
Last updated
2014-08-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00974298. Inclusion in this directory is not an endorsement.