The Benefits Of Cryoablation In Patients Undergoing Total Knee Arthroplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients with cold-related conditions (cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, and Raynaud's disease)
Surgery for fracture, infection, or malignancy
Trial design
Design model
Parallel
Treatments tested in this trial
Total knee arthroplasty (TKA)
Procedure/SurgeryAdministered as part of patient standard of care.
Cryoablation
DeviceCryoablation will be administered on the leg of the knee indicated for surgery.
Treatment groups
215 Participants
are divided into 2 treatment groupsGroup A: Total knee arthroplasty (TKA) + CryoablationExperimental treatment 2 interventions
Group B: TKA OnlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Opioid Consumption during Post-Procedural Follow-Up Period
Measured as morphine milligram equivalents.
Time frame
Month 3 Post-Operation (Approximately Week 8-9)2
Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) Score
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.
Time frame
Month 3 Post-Operation (Approximately Week 8-9)Sponsors and contacts
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Source ClinicalTrials.gov