Post-Operative PainNCT06991231
The Benefits Of Cryoablation In Patients Undergoing Total Knee Arthroplasty
A study testing Total knee arthroplasty (TKA) and Cryoablation in people with Post-Operative Pain and Total Knee Arthroplasty, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Operative Pain, Total Knee Arthroplasty
- What is being tested?
- Total knee arthroplasty (TKA) and Cryoablation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with cold-related conditions (cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, and Raynaud's disease)
- Surgery for fracture, infection, or malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: The Benefits Of Cryoablation In Patients Undergoing Total Knee Arthroplasty - A Randomized Prospective Clinical 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.
- Conditions
- Post-Operative Pain, Total Knee Arthroplasty
- Being tested
- Total knee arthroplasty (TKA), Cryoablation
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplasty (TKA)Procedure or surgery
Administered as part of patient standard of care.
CryoablationDevice
Cryoablation will be administered on the leg of the knee indicated for surgery.
| Study group | Role | What they receive |
|---|---|---|
| Total knee arthroplasty (TKA) + Cryoablation | Experimental | Patients will receive cryoablation during the two to three weeks prior to the TKA procedure. Receives: Procedure: Total knee arthroplasty (TKA); Device: Cryoablation |
| TKA Only | Active comparator | Patients will NOT receive cryoablation prior to the TKA procedure. Receives: Procedure: Total knee arthroplasty (TKA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption during Post-Procedural Follow-Up Period
Measured as morphine milligram equivalents.
Measured: 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.
Measured: Month 3 Post-Operation (Approximately Week 8-9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2025
- Study start13 Jun 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Operative PainStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 215 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua Rozell, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991231
- Sponsor's protocol ID
- 25-00306
- Status last verified
- Mar 2026
- First submitted
- 19 May 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefits Of Cryoablation In Patients Undergoing Total Knee Arthroplasty - A Randomized Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT06991231
- Acronym / sponsor ID
- 25-00306
- Conditions
- Post-Operative Pain, Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 215 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 27 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total knee arthroplasty (TKA) + Cryoablation | Experimental | Procedure: Total knee arthroplasty (TKA), Device: CryoablationPatients will receive cryoablation during the two to three weeks prior to the TKA procedure. |
| TKA Only | Active comparator | Procedure: Total knee arthroplasty (TKA)Patients will NOT receive cryoablation prior to the TKA procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with cold-related conditions (cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, and Raynaud's disease)
- Surgery for fracture, infection, or malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total knee arthroplasty (TKA)Administered as part of patient standard of care. | Procedure or surgery | TKA Only, Total knee arthroplasty (TKA) + Cryoablation |
| CryoablationCryoablation will be administered on the leg of the knee indicated for surgery. | Device | Total knee arthroplasty (TKA) + Cryoablation |
Primary outcome
Opioid Consumption during Post-Procedural Follow-Up Period
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Post-Operative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joshua Rozell, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee arthroplasty (TKA) and Cryoablation in people with Post-Operative Pain and Total Knee Arthroplasty, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Waren (212-598-6245, Daniel.waren@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Consumption during Post-Procedural Follow-Up Period (time frame: Month 3 Post-Operation (Approximately Week 8-9)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.