The Benefits Of Cryoablation In Patients Undergoing Total Knee Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Total knee arthroplasty (TKA), Cryoablation.
- Who it may be relevant to
- Registry conditions: Post-Operative Pain, Total Knee Arthroplasty. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Benefits Of Cryoablation In Patients Undergoing Total Knee Arthroplasty - A Randomized Prospective Clinical Trial
Overview
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
- Procedure Total knee arthroplasty (TKA)
Administered as part of patient standard of care. - Device Cryoablation
Cryoablation will be administered on the leg of the knee indicated for surgery.
Primary outcome measures
- Opioid Consumption during Post-Procedural Follow-Up Period [Time frame: Month 3 Post-Operation (Approximately Week 8-9)]
- Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) Score [Time frame: Month 3 Post-Operation (Approximately Week 8-9)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT06991231 · 25-00306