Uncemented Total Elbow Arthroplasty Data Collection

Total Elbow Arthroplasty Clinical Trial

Official title:

Uncemented Total Elbow Arthroplasty Data Collection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00974298
• Other study ID #: 090342
• Status: Terminated
• Phase: N/A
• First received: September 2, 2009
• Last updated: August 5, 2014
• Start date: March 2009
• Est. completion date: December 2013

Study information

• Verified date: August 2014
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients less than 18 years old

• For chart review and post-operative enrollment the patients must have adequate radiographs.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Total Elbow Arthroplasty

Intervention

Procedure:
• Total elbow replacement arthroplasty
Total elbow arthroplasty using pressfit technique in which no cement is used.

Locations

Country	Name	City	State
United States	Vanderbilt University Hand & Upper Extremity Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No