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

NCT06617338 | Terminated FDA Device

• 1 other identifier: 24.0701
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Keywords

osteoarthritis; knee; total knee arthroplasty; target alignment

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Active ROM

  preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively

Study Arms (2)

Participant receives bilateral knee CT preoperatively

EXPERIMENTAL

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

Participant receives unilateral CT of the operative knee preoperatively

ACTIVE COMPARATOR

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

Diagnostic Test: CT scan unilateral knee

Interventions

CT scan unilateral knee DIAGNOSTIC_TEST

Intervention given to the Active Comparator arm

Participant receives unilateral CT of the operative knee preoperatively

CT scan bilateral knee DIAGNOSTIC_TEST

Intervention given to the Experimental Arm

Participant receives bilateral knee CT preoperatively

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

UofL Health

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon

Model Details: Prospective, randomized cohort analysis study

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: September 27, 2024
• Study Start: December 12, 2024
• Primary Completion: February 27, 2026
• Study Completion: March 2, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

US (1)