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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-24

Study Completion Date

2026-01-01

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.

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Detailed Description

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Conditions

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Unicompartmental Knee Replacement Osteo Arthritis Knee Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Mako medial UKA

Mako medial unicondylar knee arthroplasty

Group Type EXPERIMENTAL

Medial knee arthroplasty

Intervention Type DEVICE

Surgical intervention where the medial portion of the knee is replaced by an artificial metal and polyethylene implant

Oxford media UKA

Oxford unicompartmental knee arthroplasty with navigation control

Group Type ACTIVE_COMPARATOR

Medial knee arthroplasty

Intervention Type DEVICE

Surgical intervention where the medial portion of the knee is replaced by an artificial metal and polyethylene implant

Interventions

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Medial knee arthroplasty

Surgical intervention where the medial portion of the knee is replaced by an artificial metal and polyethylene implant

Intervention Type DEVICE

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes