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

July 7, 2025 updated by: University College, London

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of component positioning
Time Frame: 6 weeks post-op
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
Time Frame: Pre-op then 6 weeks, 6 months, 1 and 2 years post-op
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
Time Frame: Pre-op then 6 weeks, 6 months, 1 and 2 years post-op
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
Time Frame: Pre-op then 6 weeks, 6 months, 1 and 2 years post-op
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
Time Frame: Intraoperative
Length of time of operation in minutes
Intraoperative
Time to discharge
Time Frame: 6 weeks post op
Length of hospital admission from admission date to documented discharge from hospital
6 weeks post op
Oxford Knee Score (OKS)
Time Frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
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
Time Frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
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)
Time Frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
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)
Time Frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
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)
Time Frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
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)
Time Frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
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
Time Frame: Pre-op then 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
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
Time Frame: Pre-op then 6 weeks post-op, 6 months post-op, one year post-op; 2 years post-op
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
Time Frame: during inpatient admission and postoperatively at 6- weeks, 6 months, 1 year and 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

Stryker Instruments

Investigators

  • Study Chair: Fares S Haddad, UCL Hospitals NHS Foundation Trust
  • Principal Investigator: Babar Kayani, UCL Hospitals NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2017

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

July 17, 2019

First Submitted That Met QC Criteria

September 17, 2019

First Posted (Actual)

September 19, 2019

Study Record Updates

Last Update Posted (Actual)

July 9, 2025

Last Update Submitted That Met QC Criteria

July 7, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16/0773

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteo Arthritis Knee

Clinical Trials on Medial knee arthroplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe