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Recruiting NCT04095637

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

No phase Interventional Unicompartmental Knee Replacement Osteo Arthritis Knee Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Medial knee arthroplasty.
Who it may be relevant to
Registry conditions: Unicompartmental Knee Replacement, Osteo Arthritis Knee, Surgery. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Accuracy of component positioning [Time frame: 6 weeks post-op]
Secondary outcome measures (12)
  • Lower limb alignment [Time frame: 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]
  • Tibial implant alignment [Time frame: Pre-op then 6 weeks, 6 months, 1 and 2 years post-op]
  • Operating time [Time frame: Intraoperative]
  • Time to discharge [Time frame: 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]
  • Short form SF-12 [Time frame: 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]
  • 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]
  • 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]
  • Mobilisation distance (metres) [Time frame: 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]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • UCL Hospital NHS Foundation Trust — London

Publications

  • 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

Identifiers

NCT: NCT04095637 · 16/0773

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗