Alignment Techniques in TKA RCT

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity & Overweight; Osteo Arthritis of the Knee
• Intervention / Treatment: Procedure: Technology-assisted inverse kinematic alignment TKA; Procedure: Manual-instrumented gap balancing alignment TKA

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jacob Elkins, MD, PHD; Phone Number: +1 319 335 7529; Email: jacob-elkins@uiowa.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Technology-assisted inverse kinematic alignment	Procedure: Technology-assisted inverse kinematic alignment TKA; This technique uses robotic or computer-assisted technology to help the surgeon place the knee implant based on the patient's individual anatomy.
Active Comparator: Manual-instrumented gap balancing alignment	Procedure: Manual-instrumented gap balancing alignment TKA; This manual technique uses standard surgical instruments and manual methods to position and balance the knee implant during surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Range of motion	From enrollment to the end of follow-up at 1 year after intervention.

Collaborators and Investigators

• Sponsor: Jacob M. Elkins

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; Osteoarthritis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nutrition Disorders; Arthritis; Joint Diseases; Rheumatic Diseases; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Osteoarthritis
• Other Study ID Numbers: 202510443

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This study will be using the OpenCap motion capture system to collect gait data of participants. These recordings are stored in the OpenCap server and thus are shared with the OpenCap developers. Participants can request the removal of these recordings.
• IPD Sharing Time Frame: Upon enrolling the first subject.
• IPD Sharing Access Criteria: Only the OpenCap developers will have access to the information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No