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

NCT04095637 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-07-09

No results posted yet for this study

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.

Conditions

  • Unicompartmental Knee Replacement
  • Osteo Arthritis Knee
  • Surgery

Interventions

DEVICE

Medial knee arthroplasty

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

Sponsors & Collaborators

  • Stryker Instruments

    collaborator INDUSTRY

  • University College, London

    lead OTHER

Principal Investigators

  • Fares S Haddad · UCL Hospitals NHS Foundation Trust

  • Babar Kayani · UCL Hospitals NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-24
Primary Completion
2025-12-31
Completion
2026-01-01
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04095637 on ClinicalTrials.gov