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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: t
View:

• • 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

Locations
Other Locations
United Kingdom
UCL Hospital NHS Foundation Trust
RECRUITING
London
Contact Information
Primary
Jenni Tahmassebi
jenni.tahmassebi1@nhs.net
02034479413
Time Frame
Start Date: 2017-11-24
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 140
Treatments
Experimental: Mako medial UKA
Mako medial unicondylar knee arthroplasty
Active_comparator: Oxford media UKA
Oxford unicompartmental knee arthroplasty with navigation control
Related Therapeutic Areas
Sponsors
Leads: University College, London
Collaborators: Stryker Instruments

This content was sourced from clinicaltrials.gov