RCT: Mako Medial Unicondylar Knee Arthroplasty vs Oxford Unicondylar Knee Arthroplasty

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Randomised Control Trial of Mako Medial Unicondylar Knee Arthroplasty Versus Jig-based Oxford Unicompartmental Knee Arthroplasty With Navigation Contro

Conditions
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Surgery, Unicompartmental Knee Replacement, Osteo Arthritis Knee

Intervention / Treatment
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* Device: Medial knee arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • 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 Criteria: • 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mako medial UKA<br>Mako medial unicondylar knee arthroplasty | Device: Medial knee arthroplasty<br>* Surgical intervention where the medial portion of the knee is replaced by an artificial metal and polyethylene implant<br>|
| Active Comparator: Oxford media UKA<br>Oxford unicompartmental knee arthroplasty with navigation control | Device: Medial knee arthroplasty<br>* Surgical intervention where the medial portion of the knee is replaced by an artificial metal and polyethylene implant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of component positioning | Comparison of accuracy of component positioning as assessed by postoperative low radiation dose CT scan | 6 weeks post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Pre-op then 6 weeks, 6 months, 1 and 2 years post-op | 
| 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. | Pre-op then 6 weeks, 6 months, 1 and 2 years post-op | 
| 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. | Pre-op then 6 weeks, 6 months, 1 and 2 years post-op | 
| Operating time | Length of time of operation in minutes | Intraoperative | 
| Time to discharge | Length of hospital admission from admission date to documented discharge from hospital | 6 weeks post op | 
| Oxford Knee Score (OKS) | Patient recorded outcome measure via questionnaire; cumulative score with best being 48, worst being 0 | Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op | 
| Short form SF-12 | Patient recorded outcome measure via questionnaire; cumulative score via 12 questions pertaining to perception of current physical and mental health; higher score best score, lower score worse score | Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op | 
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) | Patient recorded outcome measure via questionnaire; cumulative score with 0 being best score | Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op | 
| Knee injury and Osteoarthritis Outcome Score (KOOS) Osteoarthritis Outcome Score (KOOS) | Patient recorded outcome measure via questionnaire; 6 domains contribute to overall percentage; 100% being best score | Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op | 
| European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D) | Health-related quality of life via 5 domains; score -1 to 1 with 1 being best score | Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op | 
| Mobilisation distance (metres) | How far patient can walk in metres | Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op | 
| Use of mobility aids | Documenting the use of any mobility aid to assist with ambulation; can include wheelchair, walker, crutches, sticks or no aid required | Pre-op then 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op | 
| Range of movement | Range of movement of knee joint in degrees, typically from 0 to 140 degrees; higher number is better score | Pre-op then 6 weeks post-op, 6 months post-op, one year post-op; 2 years post-op | 
| Complications | Complications as relating to surgery; to include pain; fracture; neurovascular injury; blood clots; infection of wound; infection of artificial joint; pain; heart attack; stroke; pulmonary embolus; return to operating theatre; revision surgery; death | during inpatient admission and postoperatively at 6- weeks, 6 months, 1 year and 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alignment, computer navigation, implant position, mako robot, makoplasty, unicondylar knee replacement