Status:
RECRUITING
Total Versus Robotic Assisted Unicompartmental Knee Replacement
Lead Sponsor:
NHS Lothian
Conditions:
Osteo Arthritis Knee
Arthritis Knee
Eligibility:
All Genders
50-75 years
Phase:
NA
Brief 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 th...
Detailed Description
Unicompartmental knee arthroplasty (UKA) is an accepted surgical alternative to total knee arthroplasty (TKA) for patients with isolated medial compartmental joint disease with the potential advantage...
Eligibility Criteria
Inclusion
- 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
- 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,
Key Trial Info
Start Date :
August 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT05290818
Start Date
August 26 2024
End Date
December 31 2026
Last Update
November 20 2025
Active Locations (1)
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1
Nicholas Clement
Edinburgh, Lothian, United Kingdom, EH16 6SA