The Tritanium Study
Research type
Research Study
Full title
The Tritanium Uncemented Prosthesis versus the Cemented Triathlon
IRAS ID
245453
Contact name
Ben Waterson
Contact email
Sponsor organisation
RD&E Hospital NHSFT
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Total knee replacement (TKR) is one of the most successful operations performed in orthopaedics. However, many published studies have shown a reduction in bone density around traditional cemented knee joint replacements.
A loss of bone density around the knee has potentially significant consequences for patients. The bones ability to support the knee replacement may be compromised, potentially leading to early subsidence and failure of the TKR. Patients are known to be more prone to falls within the first year of having a TKR in comparison to age matched controls who have not undergone knee replacements.
Any reduction in bone density around the knee replacement increases the patients’ risk of component loosening and peri-prosthetic fracture, leading to potentially disastrous consequences.
The Triathlon knee replacement has been used at this hospital for ten years. A new version of the implant has been developed, this newer version has the same geometry as the Triathlon TKR but has been designed with a special coating which enables it to be used without cement.We aim to investigate whether there is a clinically important difference in bone density between patients undergoing two different types of knee replacement - uncemented Tritanium TKR and cemented Triathlon TKR. However, before undertaking a full randomised control trial investigating the above, it is necessary to establish whether the methodology and approach to be used are feasible. Therefore we aim to perform an internal pilot study first.
Participants will be asked to complete a series of questionnaires assessing how their knee problem affects them pre-operatively and compare this to post-operative results. We will assess bone density and total bone score via DEXA scans both before and after surgery and will compare these results against those patients receiving the cemented prosthesis.
We will analyse the results obtained to enable us to establish weather a larger trial is feasible.
REC name
Wales REC 6
REC reference
19/WA/0239
Date of REC Opinion
27 Aug 2019
REC opinion
Favourable Opinion