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 ongoing, but not recruiting participants.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01647386

First Posted: July 23, 2012

Last Update Posted: February 2, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Michael Dunbar, Nova Scotia Health Authority

Purpose

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
Revision Total Knee Replacement


Study Type:	Observational
Study Design:	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

Further study details as provided by Michael Dunbar, Nova Scotia Health Authority:

Primary Outcome Measures:

Implant Migration [ Time Frame: 2 years ]

Secondary Outcome Measures:

BMD [ Time Frame: 2 years ]

Other Outcome Measures:

Health outcome questionnaire [ Time Frame: 2 years ]


Estimated Enrollment:	10
Study Start Date:	September 2013
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	September 2017 (Final data collection date for primary outcome measure)

Groups/Cohorts
MBT Revision Component

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Senior
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

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


Responsible Party:	Michael Dunbar, Orthopedic Surgeon, Nova Scotia Health Authority
ClinicalTrials.gov Identifier:	NCT01647386 History of Changes
Other Study ID Numbers:	DEP_MBT
First Submitted:	July 19, 2012
First Posted:	July 23, 2012
Last Update Posted:	February 2, 2017
Last Verified:	February 2017

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