Alignment Techniques in TKA RCT

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.

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Key information

Conditions

Osteo Arthritis of the Knee Arthritis Body Weight Joint Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity & Overweight Osteoarthritis Overnutrition Overweight Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Technology-assisted inverse kinematic alignment TKA

Procedure

This technique uses robotic or computer-assisted technology to help the surgeon place the knee implant based on the patient's individual anatomy.

Manual-instrumented gap balancing alignment TKA

Procedure

This manual technique uses standard surgical instruments and manual methods to position and balance the knee implant during surgery.

Primary outcomes

Range of motion

Time frame: From enrollment to the end of follow-up at 1 year after intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Jacob Elkins, MD, PHD

CONTACT

[email protected]

+1 319 335 7529

Sponsors and collaborators

Lead sponsor

Jacob M. Elkins

Other

Registry information

Official study title

Investigating Alignment Techniques in Total Knee Arthroplasty for Morbid Obese Patients: Randomize Control Trial.

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2029
First posted: Jun 12, 2026
Registry last updated: Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed