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Clinical Trials/NCT00974298
NCT00974298TerminatedNot Applicable

Uncemented Total Elbow Arthroplasty Data Collection

Vanderbilt University1 site in 1 country2 target enrollmentStarted: March 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
2
Locations
1
Primary Endpoint
Patient examination measurements and radiographic measurements will be used to determine the effects of an uncemented total elbow arthroplasty

Study Overview

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.

Study Design

Study Type
Observational
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Patient examination measurements and radiographic measurements will be used to determine the effects of an uncemented total elbow arthroplasty

Time Frame: Pre-operative to five year post-operative appointment

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Donald Lee

Professor of Orthopaedic Surgery

Vanderbilt University

Study Sites (1)

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