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Alignment Techniques in TKA RCT

NCT07646158 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-06-12

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Jacob M. Elkins

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2028-07-31
Completion
2029-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07646158 on ClinicalTrials.gov