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NCT05290818
Total Versus Robotic Assisted Unicompartmental Knee Replacement
Conditions: Osteo Arthritis Knee, Arthritis Knee, Arthropathy of Knee
Sex: All
Ages: 50 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 159
Sponsor: NHS Lothian
Location: Nicholas Clement Edinburgh Lothian
Summary
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.
Eligibility 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,
Source: ClinicalTrials.gov (NCT05290818). StuddyBuddy aggregates publicly available trial information.