The Benefits Of Cryoablation In Patients Undergoing Total Knee Arthroplasty

Not Applicable

Not yet recruiting

• Conditions: Post-Operative Pain; Total Knee Arthroplasty

• Registration Number: NCT06991231
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-19
• Study First Submitted QC: 2025-05-19
• Last Update Submitted: 2025-05-19
• Study First Posted: 2025-05-27
• Last Update Posted: 2025-05-27
• Study Start: 2025-06-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 396

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States