Comparing two types of robotic-assisted knee replacement surgeries
A Prospective Randomised Control Trial Comparing Mako Robotic-arm Assisted Functionally Aligned Total Knee Arthroplasty Versus Mako Robotic-arm Assisted Mechanically Aligned Total Knee Arthroplasty
This study is testing two types of robotic knee surgeries to see which one helps people feel better and be more satisfied with their knee replacement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University College, London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT04092153 on ClinicalTrials.gov |
What this trial studies
This study evaluates the outcomes of robotic-arm assisted mechanically aligned total knee arthroplasty (MA TKA) versus functionally aligned total knee arthroplasty (FA TKA). Participants will be randomly assigned to receive either MA TKA or FA TKA, with the aim of restoring the patient's natural knee anatomy and improving satisfaction rates. The study will collect a comprehensive range of clinical and functional outcome measures, with a focus on long-term results to better understand the benefits of functional alignment. By utilizing robotic assistance, the study aims to enhance the accuracy of implant positioning and correlate outcomes with longer-term results.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-80 with symptomatic knee osteoarthritis who require primary total knee arthroplasty.
Not a fit: Patients with conditions that make them unsuitable for routine primary TKA, such as significant ligament deficiencies or those requiring revision surgery, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient satisfaction and outcomes in knee replacement surgeries.
How similar studies have performed: While early studies have shown promising outcomes for functional alignment in TKA, this study aims to provide more comprehensive data and longer-term results, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient has symptomatic knee osteoarthritis requiring primary TKA * Patient and surgeon are in agreement that TKA is the most appropriate treatment * Patient is fit for surgical intervention following review by surgeon and anaesthetist * Patient is between 18-80 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 routine primary TKA e.g. patient has ligament deficiency that requires a constrained prosthesis * Patient has bone loss that requires augmentation * Patient is not medically fit for surgical intervention * Patient requires revision surgery following previously failed correctional osteotomy or ipsilateral TKA * Patient is immobile or has another neurological condition affecting musculoskeletal function * Patient is less than 18 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
- University College London Hospital NHS Foundation Trust — London, United Kingdom (Recruiting)
Study contacts
- 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.