Overview

This trial is active, not recruiting.

Condition revision total knee replacement
Sponsor Michael Dunbar
Start date September 2013
End date September 2016
Trial size 10 participants
Trial identifier NCT01647386, DEP_MBT

Summary

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?

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm

Primary Outcomes

Measure
Implant Migration
time frame: 2 years

Secondary Outcomes

Measure
BMD
time frame: 2 years

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

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
Principal investigator Michael Dunbar
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Nova Scotia Health Authority.