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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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ClinicalTrials.gov Identifier: NCT01647386
Recruitment Status : Active, not recruiting
First Posted : July 23, 2012
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Dunbar, Nova Scotia Health Authority

Study Description
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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?


Condition or disease
Revision Total Knee Replacement

Study Design
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Study Type : Observational
Estimated Enrollment : 10 participants
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
Study Start Date : September 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018
Groups and Cohorts
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Group/Cohort
MBT Revision Component


Outcome Measures
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Primary Outcome Measures :
  1. Implant Migration [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. BMD [ Time Frame: 2 years ]

Other Outcome Measures:
  1. Health outcome questionnaire [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Failed primary TKR
Criteria

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 Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647386


Locations
Canada, Nova Scotia
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 3A7
Sponsors and Collaborators
Michael Dunbar
Investigators
Principal Investigator: Michael Dunbar Nova Scotia Health Authority
More Information
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Responsible Party: Michael Dunbar, Orthopedic Surgeon, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT01647386     History of Changes
Other Study ID Numbers: DEP_MBT
First Posted: July 23, 2012    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: February 2017