MAKO-Uni-Knee Arthroplasty Clinical Outcomes and Function (NCT03354195) | Clinical Trial Compass
CompletedNot Applicable
MAKO-Uni-Knee Arthroplasty Clinical Outcomes and Function
United States14 participantsStarted 2018-07-01
Plain-language summary
This study represents a single-surgeon/institution, non-randomized, consecutive series, prospective and comparative cohort design. The Principal Investigator is anticipating 100 study patients in the INTACT group and 35 patients in the Anterior Cruciate Ligament-Deficient group.The schedule of events lists the imaging procedures and questionnaires to be completed at each visit.
Subjects will be consented and enrolled within 28 days prior to surgery and participate in follow-up visits for two years following their Unicompartmental Knee Arthroplasty. A 3-year enrollment duration is anticipated to enroll a minimum and consecutive series of 25 patients in the experimental Anterior Cruciate Ligament-deficient group. Over the same enrollment duration, 100+ patients with intact Anterior Cruciate Ligaments are expected to be in the control group and undergo Unicompartmental Knee Arthroplasty. The enrollment duration (3 years) and total study duration (5 years) are based on patient volume estimates provided by the Principal Investigator.
Who can participate
Age range
21 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with isolated, symptomatic femorotibial knee arthritis and candidates for UKA;
. Patients ≥ 21 years old;
. Patients with intact and non-functional ACLs as determined through pre-operative imaging, knee laxity tests, rotational stability tests, and intraoperative ACL classification;
. Patients willing and able to sign an informed consent;
. Patients willing and able to comply with 2-year follow-up commitments.
Exclusion criteria
. Patients with RA;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Functional and Clinical Outcomes comparing patients with and without intact Anterior Cruciate Ligaments undergoing arthroplasty with MAKO Robotic-Arm Assisted Surgery.
Timeframe: Baseline (screening), compared to a 24 month follow-up visit. There are also several additional time points from 3 weeks, 6 weeks, 3 months, 6 months and 12 months where the functional and clinical outcomes are assessed.
Trial details
NCT IDNCT03354195
SponsorFoundation for Orthopaedic Research and Education