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

NCT04095637 | Recruiting FDA Device

• 1 other identifier: 16/0773
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

alignment; computer navigation; implant position; mako robot; makoplasty; unicondylar knee replacement

Outcome Measures

Primary Outcomes (1)

• Accuracy of component positioning

  Comparison of accuracy of component positioning as assessed by postoperative low radiation dose CT scan

  6 weeks post-op

Secondary Outcomes (14)

• Lower limb alignment

  Pre-op then 6 weeks, 6 months, 1 and 2 years post-op

• Femoral implant alignment

  Pre-op then 6 weeks, 6 months, 1 and 2 years post-op

• Tibial implant alignment

  Pre-op then 6 weeks, 6 months, 1 and 2 years post-op

• Operating time

  Intraoperative

• Time to discharge

  6 weeks post op

Study Arms (2)

Mako medial UKA

EXPERIMENTAL

Mako medial unicondylar knee arthroplasty

Device: Medial knee arthroplasty

Oxford media UKA

ACTIVE COMPARATOR

Oxford unicompartmental knee arthroplasty with navigation control

Device: Medial knee arthroplasty

Interventions

Medial knee arthroplasty DEVICE

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

Mako medial UKA; Oxford media UKA

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead
• Stryker Instruments: collaborator

Study Sites (1)

UCL Hospital NHS Foundation Trust

London, NW1 2BU, United Kingdom

RECRUITING

Related Publications (1)

• Kayani B, Konan S, Tahmassebi J, Ayuob A, Moriarty PD, Haddad FS. Robotic-arm assisted medial unicondylar knee arthroplasty versus jig-based unicompartmental knee arthroplasty with navigation control: study protocol for a prospective randomised controlled trial. Trials. 2020 Aug 17;21(1):721. doi: 10.1186/s13063-020-04631-5.

  PMID: 32807219 DERIVED

Study Officials

• Fares S Haddad

  UCL Hospitals NHS Foundation Trust

  STUDY CHAIR

• Babar Kayani

  UCL Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenni Tahmassebi

CONTACT

02034479413; jenni.tahmassebi1@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: September 19, 2019
• Study Start: November 24, 2017
• Primary Completion: December 31, 2025
• Study Completion: January 1, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)