Alignment Techniques in TKA RCT

NCT07646158 | Not Yet Recruiting Phase 4

• 1 other identifier: 202510443
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Osteo Arthritis of the Knee; Obesity & Overweight

Keywords

Osteoarthritis; Obesity

Outcome Measures

Primary Outcomes (1)

• Range of motion

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

Study Arms (2)

Technology-assisted inverse kinematic alignment

ACTIVE COMPARATOR

Procedure: Technology-assisted inverse kinematic alignment TKA

Manual-instrumented gap balancing alignment

ACTIVE COMPARATOR

Procedure: Manual-instrumented gap balancing alignment TKA

Interventions

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.

Technology-assisted inverse kinematic alignment

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.

Manual-instrumented gap balancing alignment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jacob M. Elkins: lead

MeSH Terms

Conditions

Obesity; Overweight; Osteoarthritis

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Jacob Elkins, MD, PHD

CONTACT

+1 319 335 7529; jacob-elkins@uiowa.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Upon enrolling the first subject.
• Access Criteria: Only the OpenCap developers will have access to the information.