Total Versus Robotic Assisted Unicompartmental Knee Replacement
Recruiting · NCT05290818 · Interventional (participants receive a specific treatment) · Lead sponsor: NHS Lothian
View the official record on ClinicalTrials.gov →Interventions studied
MAKO™ Partial Knee ArthroplastyTriathlon (Stryker) Total Knee Arthroplasty
What this trial is about
The purpose of this research is to compare the functional outcomes of patients with end stage medial compartment OA of the knee undergoing a conventional mTKA to those undergoing rUKA and to assess the associated cost economics of such technology.
Who can take part
Age range
50 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- Nicholas Clement - Edinburgh, Lothian, United Kingdom