Post-Operative Pain, Total Knee Arthroplasty
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of cryoablation use on patient-reported outcomes (PROMs) and opioid consumption following total knee arthroplasty. This is a randomized study that will involve a 1:1 randomization to total knee arthroplasty +/- cryoablation.
Interventions
PROCEDURETotal knee arthroplasty (TKA)
Administered as part of patient standard of care.
DEVICECryoablation
Cryoablation will be administered on the leg of the knee indicated for surgery.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients are candidates for elective primary total knee arthroplasty for a diagnosis of osteoarthritis or inflammatory arthritis. * Patients have been medically cleared and scheduled for surgery
Exclusion criteria
* Patients with cold-related conditions (cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, and Raynaud's disease) * Surgery for fracture, infection, or malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption during Post-Procedural Follow-Up Period | Month 3 Post-Operation (Approximately Week 8-9) | Measured as morphine milligram equivalents. |
| Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) Score | Month 3 Post-Operation (Approximately Week 8-9) | KOOS, JR. is a 7-item assessment of how participants feel about their knee and how well they are able to do usual activities. Each item is rated on a Likert scale; the raw score is the sum of item responses. The raw score is transformed into a total score ranging from 0-100, where 0 indicates total knee disability and 100 represents perfect knee health. |
Countries
United States
Contacts
CONTACTDaniel Waren
PRINCIPAL_INVESTIGATORJoshua Rozell, MD
NYU Langone Health
Outcome results
None listed