Native Alignment in the Setting of an Arthritic Knee in Total Knee Arthroplasty

The goal of this clinical trial is to learn if preparing the target alignment of the operative side in total knee arthroplasty (TKA) based on the non-arthritic side will give the patient better overall alignment, function, and improved results compared to basing our implant alignment and positioning off the arthritic side, which is currently the traditional method.

The main questions it aims to answer are:

• Will a patient have improved postoperative TKA results if the implant alignment is based off the non-arthritic side compared to the standard arthritic side?
• What are the similarities or differences between study arms with respect to final implant alignment and positioning angles? Researchers will compare the outcomes of two cohorts of patients undergoing primary robotic-assisted total knee arthroplasty (RA-TKA) with normal contralateral knee. Based on preoperative CT imaging, the researchers will use normal contralateral side joint numbers as the target alignment for one group (Experimental arm) and utilize the traditional method for the other group (Active comparator arm). Clinical outcomes and patient-reported outcome measures (PROMs) will be compared between groups.

Participants will:

• Be randomized into one of two study arms and will receive either a unilateral knee CT or bilateral knee CT preoperatively
• Follow-up in the clinic at 2 weeks, 6 weeks and 1-year postoperatively, per standard-of-care for x-ray and clinical evaluation.
• Complete postop questionnaires (PROMs) at the prescribed follow-up intervals

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis (OA) of the Knee
• Intervention / Treatment: Diagnostic test: CT scan bilateral knee; Diagnostic test: CT scan unilateral knee

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • UofL Health

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Patient age is 21-89 at time of surgery
2. Patient is indicated to undergo a unilateral primary TKA, secondary to osteoarthritis
3. Patient's contralateral knee is non-arthritic
4. Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document
5. Patient is able to read and speak English.

Exclusion Criteria:

1. Patient is under the age of 21
2. Patient's primary diagnosis is not osteoarthritis
3. Patient is unable to read and speak English
4. History of previous DVT/PE
5. History of stroke, CABG, or A fib
6. Current smoker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participant receives bilateral knee CT preoperatively; The P.I. (Dr. Malkani) will use normal contralateral side joint numbers as the target alignment for RA-TKA	Diagnostic test: CT scan bilateral knee; Intervention given to the Experimental Arm
Active Comparator: Participant receives unilateral CT of the operative knee preoperatively; The P.I. will use the traditional method to obtain target alignment for RA-TKA.	Diagnostic test: CT scan unilateral knee; Intervention given to the Active Comparator arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Satisfaction	Overall Satisfaction with TKA using a Likert scale	1-year postoperatively
Pain VAS	Level of knee pain (scale of zero to ten) using the Visual Analog Scale (VAS)	preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively
KOOS JR	KOOS JR questionnaire	preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively
Forgotten Joint Score	FJS-12 questionnaire	preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively
PROMIS-10 Mental and Physical Health scores	PROMIS-10 Global Health questionnaire	preoperatively and 1-year postoperatively
Incidence of revision TKA	postoperative complication requiring a revision total knee arthroplasty	1 year postop
non-revision complication	postoperative complication requiring a non-revision procedure	1 year postop

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Active ROM	Active knee range of motion: active extension, active flexion	preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively

Collaborators and Investigators

• Sponsor: University of Louisville

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2024
• Primary Completion (Actual): February 27, 2026
• Study Completion (Actual): March 2, 2026

Study Registration Dates

• First Submitted: September 25, 2024
• First Submitted That Met QC Criteria: September 25, 2024
• First Posted (Actual): September 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: osteoarthritis; knee; total knee arthroplasty; target alignment
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: 24.0701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No