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Pilot Study Using Radiostereometric Analysis (RSA) to Evaluate the Fixation of the Tibial Components in the DePuy M.B.T. Revision Knee System

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by Capital District Health Authority, Canada
Sponsor:
Information provided by (Responsible Party):
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01647386
First received: July 19, 2012
Last updated: December 12, 2014
Last verified: December 2014
History of Changes
  Purpose

Motivated by the growing number of revision total knee arthroplasty (TKAs) and the interest among surgeons to quantify the effectiveness of specific implant designs, the goal of the current project is to use Radiostereometric Analysis (RSA) to provide conclusive and clinically relevant results on fixation of the tibial component with the DePuy M.B.T. Revision TKA system using Metaphyseal Sleeves.

Does the tibial component of the M.B.T. Revision Knee System achieve adequate fixation to the underlying bone (proximal tibia) as measured by migration? • Null Hypothesis: The maximum total point motion (MTPM) value of migration of the M.B.T. Revision Knee System component between postoperative years one and two does not exceed 0.2 mm indicating adequate long-term fixation at the bone-implant interface.

• Alternative Hypothesis: The MTPM value of migration of the M.B.T. Revision Knee System component between postoperative years one and two does exceed 0.2 mm indicating inadequate long-term fixation at the bone-implant interface.

b) In what proportion of patients is adequate fixation achieved?


Condition
Revision Total Knee Replacement

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pilot Study Using Radiostereometric Analysis (RSA) to Evaluate the Fixation of the Tibial Components in the DePuy M.B.T. Revision Knee System

Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Implant Migration [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BMD [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Health outcome questionnaire [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Estimated Enrollment: 10
Study Start Date: September 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
MBT Revision Component

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Failed primary TKR

Criteria

Inclusion Criteria:

  • Revision TKA is indicated and it is the opinion of the investigator that the PFC Sigma M.B.T. Tibial component with metaphyseal sleeves and a stem is a suitable treatment
  • Contained bone defects in the proximal tibia that allow for contiguous contact between metaphyseal sleeves and cortical bone
  • Use of tibial stem
  • Ability to give informed consent

Exclusion Criteria:

  • Revision TKA due to infection
  • Patellar revision only
  • Polyethylene liner exchange only
  • Revision requiring hinged TKA
  • Uncontained defects in the proximal tibia that preclude contiguous contact between metaphyseal sleeves and cortical bone
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01647386

Locations
Canada, Nova Scotia
Capital District Health Authority Recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Contact: Elise Laende    902-412-7474    elise.laende@cdha.nshealth.ca   
Principal Investigator: Glen Richardson         
Sponsors and Collaborators
Capital District Health Authority, Canada
  More Information

No publications provided

Responsible Party: Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01647386     History of Changes
Other Study ID Numbers: DEP_MBT
Study First Received: July 19, 2012
Last Updated: December 12, 2014
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on February 27, 2015