RecruitingNot ApplicableNCT04095637

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

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

Sponsor

University College, London

Enrollment

140 participants

Start Date

Nov 24, 2017

Study Type

INTERVENTIONAL

Conditions

Surgery Osteo Arthritis Knee Unicompartmental Knee Replacement

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 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

Min Age: 40 YearsMax Age: 80 Years

Inclusion Criteria8

• 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 Criteria9

• 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

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