Comparing total knee replacement to robotic-assisted partial knee replacement
Total Versus Robotic Assisted Unicompartmental Knee Replacement (TRAKER) for Medial Compartment Osteoarthritis: Randomised Controlled Trial
NA · NHS Lothian · NCT05290818
This study is testing whether robotic-assisted partial knee replacement helps people with severe knee arthritis recover better and feel more functional than traditional total knee replacement.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 159 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | All |
| Sponsor | NHS Lothian (other gov) |
| Locations | 1 site (Edinburgh, Lothian) |
| Trial ID | NCT05290818 on ClinicalTrials.gov |
What this trial studies
This research aims to compare the functional outcomes of patients with end-stage medial compartment osteoarthritis of the knee undergoing conventional total knee arthroplasty (TKA) versus those receiving robotic-assisted unicompartmental knee arthroplasty (UKA). The study will assess the precision of component positioning and the associated recovery benefits of robotic assistance compared to manual techniques. A single-center randomized control trial will be conducted, focusing on early knee-specific functional outcomes measured by the Oxford knee score. The study also aims to evaluate the cost-effectiveness of robotic technology in knee replacement procedures.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 to 75 with end-stage medial compartment osteoarthritis who are listed for elective primary TKA.
Not a fit: Patients with significant varus deformities, fixed flexion, or those requiring additional procedures like patella resurfacing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery and functional outcomes for patients undergoing knee replacement surgery.
How similar studies have performed: Previous studies have shown promising results for robotic-assisted knee surgeries, indicating potential advantages over traditional methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Listed for elective primary TKA for end stage medial compartment osteoarthritis * Intact anterior cruciate ligament * Full thickness and good quality lateral cartilage * Correctable intra-articular varus deformity and intact medial collateral ligament * American Society of Anesthesiologists (ASA) grades 1 and 2 * Male or female, age 50 - 75 at the time of listing for surgery * Suitable candidate for a cruciate retaining TKA (Triathlon prosthesis) and a UKA Exclusion Criteria: * Varus deformity of \> 20 degrees * Fixed flexion of \>10 degrees * Patient is unable to comply with the study protocol (incl. refusal for CT scan) or functional assessments * Female participants who are pregnant, lactating or planning pregnancy during the course of the study * Requires patella resurfacing or lateral compartment has significant OA * Inability to understand the patient information for the study, provide written informed consent or answer study questionnaires for cognitive or language reasons * Inflammatory disorder e.g. rheumatoid arthritis * Symptomatic foot, hip or spine pathology * Prior surgery (other than arthroscopy) or septic arthritis of the knee * Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study,
Where this trial is running
Edinburgh, Lothian
- Nicholas Clement — Edinburgh, Lothian, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Nicholas D Clement, MD, PhD — NHS Lothian
- Study coordinator: Nicholas D Clement, MD, PhD
- Email: nick.clement@nhslothian.scot.nhs.uk
- Phone: +44 131 536 1000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osteo Arthritis Knee, Arthritis Knee, Arthropathy of Knee, Arthroplasty, Robotic, Knee, Total, Partial