Early Outcome Assessment of Revision Total Knee Arthroplasty Using Metaphyseal Sleeves

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01156558
Recruitment Status : Completed
First Posted : July 5, 2010
Last Update Posted : March 31, 2011
DePuy Orthopaedics
Information provided by:
Rothman Institute Orthopaedics

Brief Summary:
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.

Condition or disease
Revision Total Knee Replacement

Study Type : Observational
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Early Outcome Assessment of Revision Total Knee Arthroplasty Using Metaphyseal Sleeves
Study Start Date : June 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Primary Outcome Measures :
  1. Implant survivorship 2 years following revision TKA

Secondary Outcome Measures :
  1. Knee Society Score
  2. KOOS score
  3. Radiographic assessment 1 and 2 years following revision surgery

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Responsible Party: Matthew Austin, MD, Rothman Institute Identifier: NCT01156558     History of Changes
Other Study ID Numbers: 10FA01
First Posted: July 5, 2010    Key Record Dates
Last Update Posted: March 31, 2011
Last Verified: March 2011