Post-marketing surveillance study of the Triathlon Tritanium baseplate
Research type
Research Study
Full title
Five year Survival and Functional Assessment of the Triathlon cementless total knee system using the Tritanium Tibial Baseplate.
IRAS ID
204044
Contact name
Alistair M Ewen
Contact email
Sponsor organisation
Golden Jubilee Foundation
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
This study is designed to assess and measure the clinical and functional performance of the cementless Triathlon Tritanium tibial implant. In primary knee replacement, implants are usually fixed to the bone using special bone cement. However, the type of implant used in this study does not use cement for fixation but relies on the natural inherent healing process of the bone after surgery. Cementless implants, like the study implant, have a rough surface, sometimes with a special coating that encourages the natural bone to grow onto it, forming a strong and permanent bond. The study will require participants to have a total knee replacement using the study implant and then have standard and research specific follow up appointments where their recovery and progress will be measured for five years post-surgery. Participants will be treated like any other patient having a total knee replacement with the following exceptions.
They will have the study implant.
They will be required to attend the GJNH for two additional research appointments (six months and 5 years post-operation) where a total of four additional x-rays will be taken.
They will also be required to complete a research questionnaire via post or telephone contact at 3 years post- surgery.
Pre-operatively, and at their one year post-operative follow-up, they will have functional testing using the six-minute walk test and biomechanical assessment.
After their five year research follow-up, their involvement in the study will be over.REC name
West of Scotland REC 1
REC reference
16/WS/0244
Date of REC Opinion
12 Dec 2016
REC opinion
Unfavourable Opinion