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

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?

Study Overview

• Status: Completed
• Conditions: Revision Total Knee Replacement

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • Capital District Health Authority

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Failed primary TKR

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
MBT Revision Component

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Implant Migration	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
BMD	2 years

Other Outcome Measures

Outcome Measure	Time Frame
Health outcome questionnaire	2 years

Collaborators and Investigators

• Sponsor: Michael Dunbar
• Investigators: Principal Investigator: Michael Dunbar, Nova Scotia Health Authority

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: July 19, 2012
• First Submitted That Met QC Criteria: July 20, 2012
• First Posted (Estimate): July 23, 2012

Study Record Updates

• Last Update Posted (Actual): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 30, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: DEP_MBT