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
224152
Contact name
Nicholas Ohly
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
This is an assessment of the cementless Triathlon® Tritanium® tibial baseplate (Stryker) which is the latest addition to the Triathlon® knee system. It has a special coating on appropriate areas of the implant to encourage bone to grow onto it to fix it in place. We currently use the cemented version of this tibial baseplate in the Golden Jubilee National Hospital (GJNH) which is fixed in place using special bone cement. Cementless knee implants have been developed in an attempt to improve the longevity of implants, particularly in young patients with good bone stock and bone health. It is thought that having the bone integrated with the implant will result in improved long-term survival since component loosening is a major factor for survivorship in total knee arthroplasty (TKA). Loosening can be caused by bone being lost around the implant and this can be seen in x-rays.
Some of our orthopaedic consultants believe that the Tritanium® tibial baseplate could make a difference to our patient satisfaction and outcomes following TKA, but before we introduce it in routine practice, we have to ensure that it meets suitable levels of service. We plan to use the cementless study implant in a small group of participants (100) to assess its survivorship and the clinical and functional outcomes. Survivorship will be assessed with reference to those of the Orthopaedic Data Evaluation Panel. Clinical outcomes will be x-rays (to look for loosening) and questionnaires (for the participants’ satisfaction, pain and functional abilities). Functional assessment will be through the six minute walk test and biomechanical analysis to determine how the implant has improved the patients’ function.
Participants will be followed-up for five years after surgery and will be required to attend the GJNH for two additional study specific appointments over and above their standard care.REC name
West of Scotland REC 4
REC reference
17/WS/0139
Date of REC Opinion
4 Oct 2017
REC opinion
Further Information Favourable Opinion