Status:
RECRUITING
RCT: Mako Medial Unicondylar Knee Arthroplasty vs Oxford Unicondylar Knee Arthroplasty
Lead Sponsor:
University College, London
Collaborating Sponsors:
Stryker Instruments
Conditions:
Unicompartmental Knee Replacement
Osteo Arthritis Knee
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
The overall aim of this prospective, randomised, single-blinded, controlled trial is to compare clinical outcomes and accuracy of implant positioning in Mako robotic UKA versus jig-based Oxford UKA wi...
Eligibility Criteria
Inclusion
- • Patient has medial unicompartmental knee osteoarthritis requiring primary UKA
- Patient and Surgeon are in agreement that UKA is the most appropriate treatment
- Patient is fit for surgical intervention following review by surgeon and anaesthetist
- Patient is between 40-80 years of age at time of surgery
- Gender: male and female
- Patient must be capable of giving informed consent and agree to comply with the postoperative review program
- Patient must be a permanent resident in an area accessible to the study site
- Patient must have sufficient postoperative mobility to attend follow-up clinics and allow for radiographs to be taken
Exclusion
- • Patient is not suitable for primary UKA e.g. multi-compartmental knee osteoarthritis, anterior cruciate ligament rupture
- Patient is not medically fit for surgical intervention
- Patient requires revision surgery following previously failed correctional osteotomy or ipsilateral UKA
- Patient is immobile or has another neurological condition affecting musculoskeletal function
- Patient is less than 40 years of age or greater than 80 years of age
- Patient is already enrolled on another concurrent clinical trial
- Patient is unable or unwilling to sign the informed consent form specific to this study
- Patient is unable to attend the follow-up programme
- Patient is non-resident in local area or expected to leave the catchment area postoperatively
Key Trial Info
Start Date :
November 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04095637
Start Date
November 24 2017
End Date
January 1 2026
Last Update
July 9 2025
Active Locations (1)
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1
UCL Hospital NHS Foundation Trust
London, United Kingdom, NW1 2BU