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

NCT ID: NCT06617338

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-12
• Study Completion Date: 2026-05-31

Brief Summary

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

Conditions

Osteoarthritis (OA) of the Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

CT scan bilateral knee

Intervention Type: DIAGNOSTIC_TEST

Intervention given to the Experimental Arm

Participant receives unilateral CT of the operative knee preoperatively

The P.I. will use the traditional method to obtain target alignment for RA-TKA.

Group Type: ACTIVE_COMPARATOR

CT scan unilateral knee

Intervention Type: DIAGNOSTIC_TEST

Intervention given to the Active Comparator arm

Interventions

CT scan unilateral knee

Intervention given to the Active Comparator arm

Intervention Type: DIAGNOSTIC_TEST

CT scan bilateral knee

Intervention given to the Experimental Arm

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Arthur Malkani

Orthopedic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UofL Health

Louisville, Kentucky, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Langan S Smith, BS

Role: CONTACT

langan.smith@uoflhealth.org

5025878222 ext. 65585

Seth Knight, BS

Role: CONTACT

seth.knight@louisville.edu

5025878222

Facility Contacts

Langan S Smith, BS

Role: primary

langan.smith@uoflhealth.org

5025878222 ext. 65585

Other Identifiers

24.0701

Identifier Type: -

Identifier Source: org_study_id