Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Early Outcome Assessment of Revision Total Knee Arthroplasty Using Metaphyseal Sleeves

This study has been completed.
Sponsor:
Collaborator:
DePuy Orthopaedics
Information provided by:
Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier:
NCT01156558
First received: July 1, 2010
Last updated: March 30, 2011
Last verified: March 2011
  Purpose

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
Revision Total Knee Replacement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Early Outcome Assessment of Revision Total Knee Arthroplasty Using Metaphyseal Sleeves

Resource links provided by NLM:


Further study details as provided by Rothman Institute Orthopaedics:

Primary Outcome Measures:
  • Implant survivorship 2 years following revision TKA

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

Study Start Date: June 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Matthew Austin, MD, Rothman Institute
ClinicalTrials.gov Identifier: NCT01156558     History of Changes
Other Study ID Numbers: 10FA01
Study First Received: July 1, 2010
Last Updated: March 30, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 25, 2014