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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01647386

Enrollment

Registered

2012-07-23

Start date

2013-09-30

Completion date

2018-12-31

Last updated

2019-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Revision Total Knee Replacement

Brief 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?

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Implant Migration	2 years

Secondary

Measure	Time frame
BMD	2 years

Other

Measure	Time frame
Health outcome questionnaire	2 years

Countries

Canada

Outcome results