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Compares treatment options for Unicompartmental Knee Replacement
Official title RCT: Mako Medial Unicondylar Knee Arthroplasty vs Oxford Unicondylar Knee Arthroplasty
ClinicalTrials.gov ID: NCT04095637
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80. Healthy volunteers may be eligible.
You may be able to join 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
You likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.