Alignment Techniques in TKA RCT (NCT07646158) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Alignment Techniques in TKA RCT
80 participantsStarted 2026-07-01
Plain-language summary
The purpose of this research study is to compare two different methods used to align the knee during a total knee arthroplasty (TKA): technology-assisted inverse kinematic alignment, and manual-instrumented gap balancing alignment. The first technique uses robotic or computer-assisted technology to help the surgeon place the knee implant based on the patient's individual anatomy, whereas the manual technique uses standard surgical instruments and manual methods to position and balance the knee implant during surgery. The main difference is that one approach uses robotic or computer assistance to help guide implant positioning, while the other uses traditional instruments and manual surgical techniques. Both methods are commonly used and are considered standard care. The goal of this study is to understand whether one method results in better knee motion, function, and recovery after surgery in patients with higher body weight.
Who can participate
Age range
18 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:
* Being an adult (age \>= 18 years)
* Being indicated for Total Knee Arthroplasty (TKA) for the treatment of non-inflammatory knee osteoarthritis by the PI or sub-investigators.
* Having a body mass index (BMI) \>= 35 kg/m2
Exclusion Criteria:
* Patients who are unable to provide written consent
* Being under-age (age \< 18 years)
* Having a BMI \< 35 kg/m2
* Having a non-elective TKA
* Having a diagnosis of secondary or inflammatory, rheumatic, psoriatic, osteoarthritis of the index knee
* Having a local or widespread infection
* Being pregnant - Women who become pregnant at any point throughout the research study will become excluded/ineligible and will immediately stop all study activities.
* Women who are capable of becoming pregnant and not currently on contraceptives will be excluded from this study because it will be difficult to obtain the weightbearing CT using the standard CT shield for pregnant women.
* Having had a previous open surgery of the index knee
* Presence of local or widespread infection
* Having a revision TKA
* Having a simultaneous bilateral TKA
* Not being able to safely conduct study procedures - If patients are wheelchair bound or require an assistive device to stand for 5 minutes, they will be excluded from this study.
* Non-English speakers
* Prisoners
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
Range of motion
Timeframe: From enrollment to the end of follow-up at 1 year after intervention.