Cryoablation for Total Knee Replacement

Overseen By Daniel Warren

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Cold-related conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether cryoablation, a method that uses cold to numb nerves, before knee replacement surgery can improve recovery by reducing pain and the need for opioid painkillers. Participants will either receive cryoablation before their surgery or undergo the surgery alone. The trial seeks individuals planning knee replacement surgery due to arthritis and who have already been cleared for the procedure. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance recovery for future patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that cryoablation is safe for use in total knee arthroplasty?

Research has shown that cryoablation is safe and effective for individuals undergoing total knee replacement surgery. One study found that cryoneurolysis, a type of cryoablation, improved recovery by reducing the need for pain medication. As a result, patients experienced less pain and reported greater satisfaction with their surgery outcomes.

Another study demonstrated that using cryoablation during surgery lowered pain levels and accelerated pain relief. These findings suggest that cryoablation is well-tolerated and can enhance recovery after knee surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Cryoablation is unique because it offers a novel approach to pain management for total knee replacement (TKA) patients. While standard care typically involves medications like opioids and NSAIDs to control pain, cryoablation uses extreme cold to target and numb specific nerve areas, potentially reducing the need for these drugs. Researchers are excited about this treatment because it could lead to fewer side effects compared to traditional pain medications, offering a more comfortable recovery experience. Additionally, the precision of cryoablation might allow for more targeted pain relief, helping patients regain mobility faster after surgery.

What evidence suggests that cryoablation is effective for improving outcomes after total knee arthroplasty?

Research has shown that cold treatment, known as cryoablation, can reduce pain after knee replacement surgery. In this trial, one group of participants will receive cryoablation during the two to three weeks before their total knee arthroplasty (TKA) procedure. Studies have found that this cold therapy eases post-surgery pain and aids recovery. Specifically, patients who underwent a type of cryoablation during surgery, called cryo-neurolysis, experienced less pain and faster relief. Additionally, cryotherapy has been linked to better movement and reduced need for pain medication. These findings suggest that cryoablation could enhance comfort and improve recovery after knee surgery. ^{2 3 4 5 6}

Who Is on the Research Team?

Joshua Rozell, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for individuals who are undergoing total knee replacement surgery and are looking to manage postoperative pain. Specific eligibility criteria details were not provided, so participants should inquire about inclusion and exclusion criteria.

Inclusion Criteria

I am medically cleared and scheduled for surgery.

I am scheduled for knee replacement surgery due to arthritis.

Exclusion Criteria

I have a condition that worsens with cold, like Raynaud's or cold urticaria.

I had surgery for a fracture, infection, or cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment

Patients receive cryoablation during the two to three weeks prior to the TKA procedure

2-3 weeks

Treatment

Participants undergo total knee arthroplasty (TKA) with or without cryoablation

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of knee function and opioid consumption

8-9 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cryoablation

Trial Overview The study is testing the effectiveness of cryoablation—a technique that uses extreme cold to reduce pain—when combined with total knee arthroplasty (knee replacement surgery). Participants will be randomly assigned to receive either standard knee surgery or surgery with added cryoablation.

How Is the Trial Designed?

Group I: Total knee arthroplasty (TKA) + Cryoablation Experimental Treatment 2 Interventions

Patients will receive cryoablation during the two to three weeks prior to the TKA procedure.

Group II: TKA Only Active Control 1 Intervention

Patients will NOT receive cryoablation prior to the TKA procedure.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11608804/

Cryotherapy for Rehabilitation After Total Knee Arthroplasty Cryotherapy can effectively alleviate postoperative pain, reduce blood loss, improve ROM, and thus promote the postoperative rehabilitation for TKA patients.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06991231

The Benefits Of Cryoablation In Patients Undergoing Total ... The purpose of this study is to evaluate the efficacy of cryoablation use on patient-reported outcomes (PROMs) and opioid consumption following total knee ...

3. journaloei.scholasticahq.com journaloei.scholasticahq.com/article/136350-enhanced-pain-management-in-total-knee-arthroplasty-a-retrospective-analysis-on-intraoperative-cryo-neurolysis

Enhanced Pain Management in Total Knee Arthroplasty Intraoperative cryo-neurolysis significantly reduced postoperative pain and was associated with early pain resolution in TKA patients. These ...

4. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-024-07310-7

Randomized controlled trial of compressive cryotherapy ... The use of focal knee joint cryotherapy to improve functional outcomes after total knee arthroplasty: review article. PM R. 2014;6:729–38 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2772594424000086

Effectiveness comparison of genicular nerve ablation for ... 4. Results ; 3 months, Overall, 80.82% (70.34%, 88.22%) ; 3 months · OA, 80.43% (66.83%, 89.35%) ; 3 months · TKA, 81.48% (63.30%, 91.82%) ; 6 months, Overall, 56.16% ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9501843/

Cryoneurolysis Is a Safe, Effective Modality to Improve ... Cryoneurolysis is a safe, effective treatment modality to improve active functional recovery and patient satisfaction after TKA by reducing MME requirements.