Osteoarthritis (OA) of the Knee
Conditions
Keywords
osteoarthritis, knee, total knee arthroplasty, target alignment
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
Interventions
DIAGNOSTIC_TESTCT scan unilateral knee
Intervention given to the Active Comparator arm
DIAGNOSTIC_TESTCT scan bilateral knee
Intervention given to the Experimental Arm
Sponsors
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Prospective, randomized cohort analysis study
Eligibility
Sex/Gender
ALL
Age
21 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Satisfaction | 1-year postoperatively | Overall Satisfaction with TKA using a Likert scale |
| Pain VAS | preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively | Level of knee pain (scale of zero to ten) using the Visual Analog Scale (VAS) |
| KOOS JR | preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively | KOOS JR questionnaire |
| Forgotten Joint Score | preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively | FJS-12 questionnaire |
| PROMIS-10 Mental and Physical Health scores | preoperatively and 1-year postoperatively | PROMIS-10 Global Health questionnaire |
| Incidence of revision TKA | 1 year postop | postoperative complication requiring a revision total knee arthroplasty |
| non-revision complication | 1 year postop | postoperative complication requiring a non-revision procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Active ROM | preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively | Active knee range of motion: active extension, active flexion |
Countries
United States
Outcome results
None listed