We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT01156558
Recruitment Status : Completed
First Posted : July 5, 2010
Last Update Posted : March 31, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
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 Design

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
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
Criteria

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
More Information

Responsible Party: Matthew Austin, MD, Rothman Institute
ClinicalTrials.gov 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