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

University College London (UCL)

Status: Enrolling

Conditions: Surgery; Unicompartmental Knee Replacement; Osteo Arthritis Knee

Treatments: Device: Medial knee arthroplasty

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04095637

16/0773

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups

Mako medial UKA

Experimental group

Description:

Mako medial unicondylar knee arthroplasty

Treatment:

Device: Medial knee arthroplasty

Oxford media UKA

Active Comparator group

Description:

Oxford unicompartmental knee arthroplasty with navigation control

Treatment:

Device: Medial knee arthroplasty