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

University College, London140 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

140

Conditions

Unicompartmental Knee Replacement Osteo Arthritis Knee Surgery

Interventions

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Accuracy of component positioning

Comparison of accuracy of component positioning as assessed by postoperative low radiation dose CT scan

Time frame: 6 weeks post-op

Secondary Outcomes

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-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.

Time frame: 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.

Time frame: Pre-op then 6 weeks, 6 months, 1 and 2 years post-op

Operating time

Length of time of operation in minutes

Time frame: Intraoperative

Time to discharge

Length of hospital admission from admission date to documented discharge from hospital

Time frame: 6 weeks post op

Oxford Knee Score (OKS)

Patient recorded outcome measure via questionnaire; cumulative score with best being 48, worst being 0