Uncemented Total Elbow Arthroplasty Data Collection

Terminated

• Conditions: Total Elbow Arthroplasty
• Interventions: Procedure: Total elbow replacement arthroplasty

• Registration Number: NCT00974298
• Lead Sponsor: Vanderbilt University

Brief 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-09-02
• Study First Submitted QC: 2009-09-09
• Study First Posted: 2009-09-10
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-05
• Last Update Posted: 2014-08-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Any patient who has had a total elbow arthroplasty using a press-fit technique at the Vanderbilt Hand & Upper Extremity Center

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Exclusion Criteria

• Patients less than 18 years old
• For chart review and post-operative enrollment the patients must have adequate radiographs.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Elbow replacement	Total elbow replacement arthroplasty	There are no other arms other then an uncemented total elbow replacement.

Primary Outcome Measures

Name	Time	Method
Patient examination measurements and radiographic measurements will be used to determine the effects of an uncemented total elbow arthroplasty	Pre-operative to five year post-operative appointment

Trial Locations

Locations (1)

Vanderbilt University Hand & Upper Extremity Center; 🇺🇸 Nashville, Tennessee, United States