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
This trial accepts healthy volunteersQualifiers
• 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
Design model
Parallel
Treatments tested in this trial
Medial knee arthroplasty
DeviceSurgical intervention where the medial portion of the knee is replaced by an artificial metal and polyethylene implant
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Mako medial UKAExperimental treatment 1 intervention
Group B: Oxford media UKAActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Accuracy of component positioning
Comparison of accuracy of component positioning as assessed by postoperative low radiation dose CT scan
Time frame
6 weeks post-opSecondary outcomes
1
Lower limb alignment
Lower limb alignment in the coronal, axial, and sagittal planes as assessed by postoperative low radiation dose CT scan at 6 weeks after surgery.
Time frame
Pre-op then 6 weeks, 6 months, 1 and 2 years post-op2
Femoral implant alignment
Femoral implant alignment in the coronal, axial, and sagittal planes as assessed by postoperative low radiation dose CT scan at 6 weeks after surgery.
Time frame
Pre-op then 6 weeks, 6 months, 1 and 2 years post-op3
Tibial implant alignment
Tibial implant alignment in the coronal, axial, and sagittal planes as assessed by postoperative low radiation dose CT scan at 6 weeks after surgery.
Time frame
Pre-op then 6 weeks, 6 months, 1 and 2 years post-op4
Operating time
Length of time of operation in minutes
Time frame
IntraoperativeSponsors and contacts
Click on the lead sponsor to view all of their trials.
University College, London
Lead sponsor
Stryker Instruments
Collaborator
Source ClinicalTrials.gov