The Benefits Of Cryoablation In Patients Undergoing Total Knee Arthroplasty
1 other identifier
interventional
396
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable postoperative-pain
Started Jun 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2025
CompletedFirst Posted
Study publicly available on registry
May 27, 2025
CompletedStudy Start
First participant enrolled
June 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedMay 27, 2025
May 1, 2025
7 months
May 19, 2025
May 19, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Opioid Consumption during Post-Procedural Follow-Up Period
Measured as morphine milligram equivalents.
Month 3 Post-Operation (Approximately Week 8-9)
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.
Month 3 Post-Operation (Approximately Week 8-9)
Study Arms (2)
Total knee arthroplasty (TKA) + Cryoablation
EXPERIMENTALPatients will receive cryoablation during the two to three weeks prior to the TKA procedure.
TKA Only
ACTIVE COMPARATORPatients will NOT receive cryoablation prior to the TKA procedure.
Interventions
Administered as part of patient standard of care.
Cryoablation will be administered on the leg of the knee indicated for surgery.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with cold-related conditions (cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, and Raynaud's disease)
- Surgery for fracture, infection, or malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joshua Rozell, MD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2025
First Posted
May 27, 2025
Study Start
June 1, 2025
Primary Completion
January 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
May 27, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Daniel.waren@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Daniel.waren@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.