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

Revision Total Knee Replacement Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01647386
• Other study ID #: DEP_MBT
• Status: Completed
• Start date: September 2013
• Est. completion date: December 2018

Study information

• Verified date: January 2019
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Revision Total Knee Replacement

Locations

Country	Name	City	State
Canada	Capital District Health Authority	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Michael Dunbar

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health outcome questionnaire		2 years
Primary	Implant Migration		2 years
Secondary	BMD		2 years