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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Capital District Health Authority, Canada
Sponsor:
Information provided by (Responsible Party):
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01647386
First received: July 19, 2012
Last updated: March 28, 2014
Last verified: March 2014

July 19, 2012
March 28, 2014
September 2013
September 2016   (final data collection date for primary outcome measure)
Implant Migration [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01647386 on ClinicalTrials.gov Archive Site
BMD [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Health outcome questionnaire [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
 
Pilot Study Using Radiostereometric Analysis (RSA) to Evaluate the Fixation of the Tibial Components in the DePuy M.B.T. Revision Knee System
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?

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Failed primary TKR

Revision Total Knee Replacement
Not Provided
MBT Revision Component
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
January 2017
September 2016   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Canada
 
NCT01647386
DEP_MBT
No
Capital District Health Authority, Canada
Capital District Health Authority, Canada
Not Provided
Not Provided
Capital District Health Authority, Canada
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP