Clinical trial NCT06617338: Native Alignment in the Setting of an Arthritic Knee in Total Knee Arthroplasty
Official title: Native Alignment in the Setting of an Arthritic Knee in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis (OA) of the Knee
Keywords: osteoarthritis
knee
total knee arthroplasty
target alignment
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized cohort analysis study
Primary purpose: BASIC_SCIENCE

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


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

Primary outcomes:
measure: Overall Satisfaction
timeFrame: 1-year postoperatively
measure: Pain VAS
timeFrame: preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively
measure: KOOS JR
timeFrame: preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively
measure: Forgotten Joint Score
timeFrame: preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively
measure: PROMIS-10 Mental and Physical Health scores
timeFrame: preoperatively and 1-year postoperatively
measure: Incidence of revision TKA
timeFrame: 1 year postop
measure: non-revision complication
timeFrame: 1 year postop
Secondary outcomes:
measure: Active ROM
timeFrame: preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively
Other outcomes:
Locations:
city: Louisville
country: United States
facility: UofL Health
state: Kentucky
Study officials:
References: