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

NCT01647386 | Completed

• 1 other identifier: DEP_MBT
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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?

Conditions

Revision Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

• Implant Migration

  2 years

Secondary Outcomes (1)

• BMD

  2 years

Other Outcomes (1)

• Health outcome questionnaire

  2 years

Study Arms (1)

MBT Revision Component

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Failed primary TKR

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michael Dunbar: lead

Study Sites (1)

Capital District Health Authority

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Study Officials

• Michael Dunbar

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Orthopedic Surgeon

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: July 23, 2012
• Study Start: September 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

CA (1)