The TOPKAT clinical trial, is a multi-centre randomised trial to measure the clinical and cost effectiveness of total and partial knee replacements for medial compartmental osteoarthritis.
SITU will co-ordinate the trial via OSIRIS in collaboration with the Health Services Research Unit at the University of Aberdeen. The project is funded by the NIHR Health Technology Assessment programme.
In the majority of patients with osteoarthritis of the knee the disease originates in the medial compartment. There are two different approaches to replacing this arthritic area. Some surgeons feel that it is always best to replace both the knee compartments with a Total Knee Replacement (TKR). Others feel it is best to replace just the damaged component of the knee with a Unicompartmental Replacement (UKR). There is little agreement amongst knee surgeons. Both interventions are established and well documented procedures, yet little evidence exists to support their practices. Each intervention is considered standard care but little evidence exists to prove the clinical and cost effectiveness of either management option.
The aim of TOPKAT will be to assess the clinical and cost effectiveness of Total Knee Replacements versus Unicompartmental Knee Replacements in patients with medial osteoarthritis.
Study Participants and Recruitment
Patients will be recruited by their Consultant Knee Surgeon in collaboration with the local research team. TOPKAT will aim to recruit 500 patients altogether from approximately 20 centres throughout the United Kingdom. Patient recruitment is over a 2 year period. Information to be collected and analysed includes: Patient focused questionnaires regarding knee pain and function; Patient focused questionnaires regarding the economic cost of the treatment; Health care resources used (i.e. hospital stays, operating theatre equipment); Post operative radiological assessments.
- Medial osteoarthritis with exposed bone on both Femur and Tibia
- Functionally intact Anterior Cruciate Ligament
- Full thickness lateral cartilage
- Correctable intra-articular varus deformity
- Medically fit showing an ASA of 1 or 2
- Require revision knee replacement surgery
- Have Rheumatoid arthritis or other Inflammatory disorders
- Are unlikely to be able to perform required clinical assessment tasks
- Have symptomatic foot, hip or spinal pathology
- Previous knee surgery
- Previously had septic arthritis
- Significant PFJ damage especially to the lateral facet