Uncemented Total Elbow Arthroplasty Data Collection

August 5, 2014 updated by: Donald Lee, Vanderbilt University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232-8828
        • Vanderbilt University Hand & Upper Extremity Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who require total elbow arthroplasty.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Pre-operative to five year post-operative appointment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Investigators

  • Principal Investigator: Donald Lee, M.D., Vanderbilt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

September 2, 2009

First Submitted That Met QC Criteria

September 9, 2009

First Posted (Estimate)

September 10, 2009

Study Record Updates

Last Update Posted (Estimate)

August 6, 2014

Last Update Submitted That Met QC Criteria

August 5, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 090342

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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