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

Sponsor: University College, London

NCT ID: NCT04095637

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Medial knee arthroplasty (device)
How long the study runs
Study runs about 98 months (dates as stated)
About the drug or intervention
Medial knee arthroplasty — device: Surgical intervention where the medial portion of the knee is replaced by an artificial metal and polyethylene implant
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
40 Years to 80 Years
Who
All
Number of participants
140
Started
2017-11-24
Last checked
2025-07

Plain English Summary

What is this study?

  • • Testing a new treatment for unicompartmental knee replacement
  • • NA - 140 participants
  • • 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

Who can take part?

  • • Ages 40 Years to 80 Years
  • • Diagnosed with unicompartmental knee replacement

Where?

  • • London - UCL Hospital NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Unicompartmental Knee ReplacementOsteo Arthritis KneeSurgery

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 40 Years - 80 Years
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ sufficient postoperative mobility to attend follow-up clinics and allow for radiographs to be taken

What the study is looking for

  • ✓• 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

Who cannot take part

  • ✗• Patient is not suitable for primary UKA e.g. multi-compartmental knee osteoarthritis, anterior cruciate ligament...
  • ✗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
See the full criteria
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

Where Is This Study? (1 UK site)

UCL Hospital NHS Foundation Trust

London NW1 2BU, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Jenni Tahmassebi

Sponsor contact

CONTACT

02034479413 jenni.tahmassebi1@nhs.net
Data sourced from ClinicalTrials.gov · Last verified: 2025-07