Comparing two methods of knee replacement surgery
A Prospective Randomised Control Trial of Mako Medial Unicondylar Knee Arthroplasty Versus Jig-based Oxford Unicompartmental Knee Arthroplasty With Navigation Contro
This study tests whether a robotic knee replacement surgery works better than a traditional method for people with knee osteoarthritis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | University College, London Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (London) |
| Trial ID | NCT04095637 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the clinical outcomes and accuracy of implant positioning between Mako robotic unicondylar knee arthroplasty and jig-based Oxford unicondylar knee arthroplasty with navigation control. Patients will be randomly assigned to receive either the Mako robotic procedure or the Oxford procedure. The primary objective is to assess the accuracy of component positioning using low radiation dose CT scans postoperatively. This study will help determine which surgical method provides better outcomes for patients with medial unicompartmental knee osteoarthritis.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40-80 with medial unicompartmental knee osteoarthritis who are fit for surgical intervention.
Not a fit: Patients with multi-compartmental knee osteoarthritis or those not medically fit for surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and more accurate knee replacements for patients with osteoarthritis.
How similar studies have performed: Other studies have shown promising results with robotic-assisted surgeries, suggesting potential benefits in accuracy and outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
London
- UCL Hospital NHS Foundation Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Babar Kayani — UCL Hospitals NHS Foundation Trust
- Study coordinator: Jenni Tahmassebi
- Email: jenni.tahmassebi1@nhs.net
- Phone: 02034479413
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.