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

University of Louisville (UOFL)

Status: Enrolling

Conditions: Osteoarthritis (OA) of the Knee

Treatments: Diagnostic Test: CT scan bilateral knee; Diagnostic Test: CT scan unilateral knee

Study type: Interventional

Funder types: Other

Identifiers

NCT06617338

24.0701

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 21 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Participant receives bilateral knee CT preoperatively

Experimental group

Description:

The P.I. (Dr. Malkani) will use normal contralateral side joint numbers as the target alignment for RA-TKA

Treatment:

Diagnostic Test: CT scan bilateral knee

Participant receives unilateral CT of the operative knee preoperatively

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: CT scan unilateral knee