NCT07646158Not yet recruitingPhase 4
Alignment Techniques in TKA RCT
Investigating Alignment Techniques in Total Knee Arthroplasty for Morbid Obese Patients: Randomize Control Trial.
Source: ClinicalTrials.gov · Last updated 12 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 8 Jun 2026
- Start date
- Jul 2026
- Primary completion date
- Jul 2028
- Lead sponsor
- Jacob M. Elkins
- Diseases
- Obesity
- NCT number
- NCT07646158
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 80
- From Jul 2026 to the primary completion date, Jul 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Having a local or widespread infection
- Presence of local or widespread infection
Age
- Being under-age (age \< 18 years)
Other
- Patients who are unable to provide written consent
- 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
- Being pregnant - Women who become pregnant at any point throughout the research study will become excluded/ineligible and will immediately stop all study activities.
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.