Early Outcome Assessment of Revision Total Knee Arthroplasty Using Metaphyseal Sleeves

March 30, 2011 updated by: Rothman Institute Orthopaedics
Metaphyseal sleeves, through their design, could allow reconstruction of the knee in cases of severe bone loss by allowing rigid internal fixation and proper alignment of the extremity and components.

Study Overview

Status

Completed

Conditions

Study Type

Observational

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

Sequential assessment of 100 patients who have received a revision knee surgery for which metaphyseal sleeve was used in femoral and/or tibial side starting August 2007. Patients must meet inclusion/exclusion criteria for enrollment.

Description

Inclusion Criteria:

  1. Revision knees with bone defect for which metaphyseal sleeve in femoral and/or tibial side is used
  2. Cases with at least 2 year follow-up
  3. Cases with regular follow-up visits completed

Exclusion Criteria:

  1. Cemented sleeves
  2. Patients with less than two year follow-up completed
  3. Cases lost to follow-up

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Implant survivorship 2 years following revision TKA

Secondary Outcome Measures

Outcome Measure
Knee Society Score
KOOS score
Radiographic assessment 1 and 2 years following revision surgery

Collaborators and Investigators

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

Sponsor

Rothman Institute Orthopaedics

Collaborators

DePuy Orthopaedics

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

June 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

July 1, 2010

First Submitted That Met QC Criteria

July 1, 2010

First Posted (Estimate)

July 5, 2010

Study Record Updates

Last Update Posted (Estimate)

March 31, 2011

Last Update Submitted That Met QC Criteria

March 30, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • 10FA01

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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