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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
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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 |
- Implant Migration [ Time Frame: 2 years ]
- BMD [ Time Frame: 2 years ]
- Health outcome questionnaire [ Time Frame: 2 years ]
| Estimated Enrollment: | 10 |
| Study Start Date: | September 2013 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | September 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| MBT Revision Component |
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01647386
| Canada, Nova Scotia | |
| Capital District Health Authority | |
| Halifax, Nova Scotia, Canada, B3H 3A7 | |
| Principal Investigator: | Michael Dunbar | Nova Scotia Health Authority |
More Information
| Responsible Party: | Michael Dunbar, Orthopedic Surgeon, Nova Scotia Health Authority |
| ClinicalTrials.gov Identifier: | NCT01647386 History of Changes |
| Other Study ID Numbers: |
DEP_MBT |
| Study First Received: | July 19, 2012 |
| Last Updated: | February 1, 2017 |
ClinicalTrials.gov processed this record on August 18, 2017