RCT: Mako Medial Unicondylar Knee Arthroplasty vs Oxford Unicondylar Knee Arthroplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorUniversity College, London
About this trial
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 with navigation control. Patients receiving the Mako robotic UKA (Stryker Ltd) will form the investigation group and those undergoing the jig-based Oxford UKA (Zimmer-Biomet Ltd) with navigation control will form the control group.
The primary objective in this study is to compare accuracy of component positioning as assessed by postoperative low radiation dose CT scan between conventional Jig-based Oxford UKA with navigation control and Mako robotic UKA.
Eligibility criteria
Qualifiers
• 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
Disqualifiers
• 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
Trial design
Treatments tested in this trial
- Medial knee arthroplasty
Treatment groups
140 Participants
are divided into 2 treatment groupsSponsors and collaborators
University College, London
Lead sponsor
Stryker Instruments
Collaborator
Source ClinicalTrials.gov