Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Uncemented Total Elbow Arthroplasty Data Collection

This study has been terminated.
Information provided by (Responsible Party):
Donald Lee, Vanderbilt University Identifier:
First received: September 2, 2009
Last updated: August 5, 2014
Last verified: August 2014

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.

Condition Intervention
Total Elbow Arthroplasty
Procedure: Total elbow replacement arthroplasty

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Uncemented Total Elbow Arthroplasty Data Collection

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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 ]

Enrollment: 2
Study Start Date: March 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Elbow replacement
There are no other arms other then an uncemented total elbow replacement.
Procedure: Total elbow replacement arthroplasty
Total elbow arthroplasty using pressfit technique in which no cement is used.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who require total elbow arthroplasty.


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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00974298

United States, Tennessee
Vanderbilt University Hand & Upper Extremity Center
Nashville, Tennessee, United States, 37232-8828
Sponsors and Collaborators
Vanderbilt University
Principal Investigator: Donald Lee, M.D. Vanderbilt University
  More Information

No publications provided

Responsible Party: Donald Lee, Professor of Orthopaedic Surgery, Vanderbilt University Identifier: NCT00974298     History of Changes
Other Study ID Numbers: 090342
Study First Received: September 2, 2009
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board processed this record on February 27, 2015