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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 89
Healthy Volunteers: f
View:

• Patient age is 21-89 at time of surgery

• Patient is indicated to undergo a unilateral primary TKA, secondary to osteoarthritis

• Patient's contralateral knee is non-arthritic

• Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document

• Patient is able to read and speak English.

Locations
United States
Kentucky
UofL Health
RECRUITING
Louisville
Contact Information
Primary
Langan S Smith, BS
langan.smith@uoflhealth.org
5025878222
Backup
Seth Knight, BS
seth.knight@louisville.edu
5025878222
Time Frame
Start Date: 2024-12-12
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 200
Treatments
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
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.
Sponsors
Leads: University of Louisville

This content was sourced from clinicaltrials.gov