Uncemented Total Elbow Arthroplasty Data Collection

This study is currently recruiting participants.
Verified February 2013 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Donald Lee, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00974298
First received: September 2, 2009
Last updated: February 4, 2013
Last verified: February 2013

September 2, 2009
February 4, 2013
March 2009
March 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00974298 on ClinicalTrials.gov Archive Site
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Uncemented Total Elbow Arthroplasty Data Collection
Uncemented Total Elbow Arthroplasty Data Collection

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.

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
Observational
Time Perspective: Prospective
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Non-Probability Sample

Patients who require total elbow arthroplasty.

Total Elbow Arthroplasty
Procedure: Total elbow replacement arthroplasty
Total elbow arthroplasty using pressfit technique in which no cement is used.
Elbow replacement
There are no other arms other then an uncemented total elbow replacement.
Intervention: Procedure: Total elbow replacement arthroplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
March 2014
March 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Julie M Daniels, BBA 6153224506 Julie.M.Daniels@Vanderbilt.edu
United States
 
NCT00974298
090342
No
Donald Lee, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: Donald Lee, M.D. Vanderbilt University
Vanderbilt University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP