Robotic vs. manual knee alignment: which is better for heavier patients?
NCT ID NCT07646158
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two ways to align the knee during total knee replacement in 80 obese adults (BMI 35+). One method uses robotic or computer assistance, the other uses traditional manual tools. The goal is to see which leads to better knee motion and recovery after surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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