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Completed

NCT Number: NCT01647386

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?

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Key information

Conditions

Revision Total Knee Replacement

Sex eligibility

All sexes

Study type

Observational

Primary location

Capital District Health Authority

Halifax, Nova Scotia, B3H 3A7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Implant Migration

    Time frame: 2 years

Secondary outcomes

  1. BMD

    Time frame: 2 years

Other outcomes

  1. Health outcome questionnaire

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Michael Dunbar

Other

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jul 23, 2012
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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