Cryoneurolysis for ACL Reconstruction

Recruiting at 1 trial location

Overseen By Sean Mc Millan, DO

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Virtua Health, Inc.

Must not be taking: Opioids

Disqualifiers: Under 14, Non-English, Reynauds, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether Cryoneurolysis, a technique using extreme cold to numb nerves, can reduce pain after ACL reconstruction surgery. Participants will be divided into two groups: one receiving standard care and the other receiving standard care plus Cryoneurolysis. The researchers aim to determine if the additional treatment can ease recovery by reducing pain. Suitable candidates have not regularly used opioids and plan to undergo ACL reconstruction using their own tendon. As an unphased trial, this study provides a unique opportunity to explore innovative pain management techniques that could improve recovery experiences.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants should be opioid naïve, meaning they should not be regularly using opioids before the surgery.

What prior data suggests that Cryoneurolysis is safe for knee pain management?

Research has shown that cryoneurolysis, a treatment using extreme cold to target nerves, is generally safe and well-tolerated. Studies have found a low risk of complications when performed with imaging guidance, which ensures accuracy and safety.

Additionally, cryoneurolysis is an approved method for reducing or eliminating pain by freezing specific nerves, indicating its safety for use in certain situations.

While this information is not specific to this trial, it provides reassurance about the safety of cryoneurolysis for those considering participation in related clinical research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Cryoneurolysis is unique because it uses extreme cold to precisely target and temporarily disable specific nerves that send pain signals, offering a novel approach to pain management. Unlike traditional methods for ACL reconstruction, which often rely on various pain medications and nerve blocks, cryoneurolysis can potentially reduce the need for opioids and enhance recovery by providing longer-lasting pain relief before surgery. Researchers are excited about this technique because it could lead to better pain control, less reliance on medications, and a more comfortable recovery period for patients undergoing ACL reconstruction surgery.

What evidence suggests that Cryoneurolysis is effective for postoperative pain management in ACL reconstruction?

Research has shown that using extreme cold to target specific nerves, known as cryoneurolysis, can effectively reduce pain after ACL reconstruction surgery. In this trial, one group of participants will receive usual care plus pre-operative cryoneurolysis. Studies have demonstrated that cryotherapy, a similar cold treatment, significantly helps control pain for patients recovering from this surgery. A review of multiple studies found that cryotherapy offers a clear benefit in managing pain after ACL surgery. These findings suggest that applying cold to nerves before surgery, as with cryoneurolysis, may help ease pain afterward. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for patients scheduled for ACL reconstruction using their own tendon. They must be able to undergo standard care and willing to potentially receive Cryoneurolysis before surgery. Specific eligibility criteria are not provided, but typically include being in good health with no conditions that would interfere with the study or recovery.

Inclusion Criteria

Patients who are opioid naïve

I am 14 years old or older.

I am having ACL reconstruction using my own tissue.

Exclusion Criteria

I do not speak or read English.

I am having ACL surgery using donor tissue.

Patients who consistently use opioids preoperatively

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Participants in Group B receive Cryoneurolysis treatment 7-10 days before surgery

1-2 weeks

1 visit (in-person)

Surgery and Immediate Post-operative Care

Participants undergo ACL reconstruction and receive standard preoperative and postoperative pain management

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, with assessments at 1-week, 6-weeks, and 12-weeks post-surgery

12 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cryoneurolysis

Trial Overview The study tests if applying extreme cold (Cryoneurolysis) to nerves around the knee before ACL surgery can reduce pain after the operation. Participants will either get standard care or standard care plus Cryoneurolysis, chosen randomly, and compare their post-surgery pain medication use.

How Is the Trial Designed?

Group I: Arm B: Usual care plus pre-operative cryoneurolysis Experimental Treatment 1 Intervention

Those randomized to the intervention group (Group B) will receive a standard treatment of Cryoneurolysis to their surgical knee within 7-10 days of their scheduled surgery. Treatment nerves for the procedure will include the anterior femoral cutaneous nerve (AFCN), supra-patellar branch of the saphenous nerve (SPBSN) and infra-patellar branch of the saphenous nerve (IPBSN).

Group II: Arm A: ACL reconstruction usual care Active Control 1 Intervention

On the day of surgery, all patients (Group A and Group B) will receive a multi-modal oral pre-operative cocktail and an ultrasound guided adductor canal block. Additionally, an ultrasound guided popliteal or infiltration of the tissue plane between the popliteal artery and the capsule of the knee (iPACK) block will be administered. The pre-operative oral medication cocktail and block medications are as follows: Acetaminophen 975 mg x 1, Celecoxib 400 mg PO x 1, adductor canal block with 133 mg (10 mL) liposomal bupivacaine (EXPAREL) admixed with 0.5% bupivacaine HCl 50 mg (10 mL), popliteal or iPACK nerve infiltration with 133 mg (10 mL) liposomal bupivacaine (EXPAREL) admixed with 0.5% bupivacaine HCl 50 mg (10 mL). 15 mg IV ketorolac at conclusion of the case will be administered.

Who Is Running the Clinical Trial?

Virtua Health, Inc.

Lead Sponsor

Trials

10

Recruited

690+

Pacira Pharmaceuticals, Inc

Industry Sponsor

Trials

142

Recruited

14,300+

Headquarters

Tampa, USA

Known For

Non-opioid Pain Management

Top Products

Exparel, Zilretta, iovera

Dr. Jonathan Slonin

Pacira Pharmaceuticals, Inc

Chief Medical Officer since 2020

BSc in Biomedical Engineering and MD from University of Miami, MBA from George Washington University

Frank D. Lee

Pacira Pharmaceuticals, Inc

Chief Executive Officer since 2024

BSc in Chemical Engineering from Vanderbilt University, MBA from Wharton Graduate School of Business

Published Research Related to This Trial

Cryoanalgesia, or cryoneurolysis, is a safe and effective method for relieving pain by applying extreme cold to peripheral nerves, interrupting pain signals without causing permanent nerve damage.

This technique, guided by imaging methods like ultrasound or CT, offers a minimally invasive alternative to traditional pain management approaches, especially important in the context of the opioid crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous cryoanalgesia for pain palliation: Current status and future trends. Filippiadis, D., Efthymiou, E., Tsochatzis, A., et al.[2021]

In a study involving 113 patients undergoing ultrasound-guided percutaneous cryoneurolysis for spasticity, 96.75% of nerve treatments resulted in no significant pain or dysesthesias beyond the treatment period, indicating a high safety profile.

While a few patients experienced temporary nerve pain or numbness, most adverse effects were manageable and resolved within three months, suggesting that cryoneurolysis could be a safe and effective treatment option for spasticity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Adverse Effects of Cryoneurolysis for the Treatment of Spasticity. Winston, P., MacRae, F., Rajapakshe, S., et al.[2023]

Ultrasound-guided cryoablation of intercostal nerves has been successfully performed in four patients with postthoracotomy pain syndrome, providing pain relief for at least one month without any complications.

The use of ultrasound enhances the safety of the procedure by allowing visualization of the pleura, which is particularly beneficial in thin patients, potentially reducing the risk of pneumothorax and improving the success rate of cryoablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided intercostal nerve cryoablation. Byas-Smith, MG., Gulati, A.[2016]

Ultrasound-guided percutaneous cryoanalgesia effectively targets intercostal nerves to provide postoperative pain relief after thoracic surgery, which is crucial for improving lung function and reducing complications.

Using a high-frequency ultrasound probe allows for precise placement of the cryoprobe near the intercostal nerve, confirmed by specific ultrasound signs, enhancing the efficacy of the cryoanalgesia technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short communication: ultrasound-guided percutaneous cryoanalgesia of intercostal nerves for uniportal video-assisted thoracic surgery. Nicolás, M., Acosta, CM., Martinez Ferro, M., et al.[2022]

Ultrasound guidance during cryoneurolysis allows for real-time monitoring of needle placement, leading to more accurate targeting of peripheral nerves and improved outcomes in pain relief.

Patients have reported varying degrees of long-term pain relief and functional improvement from cryoneurolysis, with no serious complications noted, suggesting it is a safe alternative to other pain management techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Cryoanalgesia of Peripheral Nerve Lesions. Djebbar, S., Rossi, IM., Adler, RS.[2017]

Ultrasound-guided percutaneous cryoneurolysis significantly reduced pain levels on postoperative day 2 after mastectomy, with active treatment participants reporting a median pain score of 0 compared to 3 in the sham group (P < 0.001).

The technique also led to a dramatic reduction in opioid use during the first three weeks post-surgery, with the active group using only 1.5 mg of oxycodone compared to 72 mg in the sham group, and resulted in lower rates of chronic pain after one year (3% in active vs 17% in sham, P < 0.001).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative Ultrasound-guided Percutaneous Cryoneurolysis for the Treatment of Pain after Mastectomy: A Randomized, Participant- and Observer-masked, Sham-controlled Study. Ilfeld, BM., Finneran, JJ., Swisher, MW., et al.[2023]

The size of the ice ball created during ultrasound-guided percutaneous cryoneurolysis is significantly influenced by the gauge of the cryoprobe used, with larger probes (14 gauge) producing ice balls that are up to 512% larger and achieving much lower temperatures compared to smaller probes (18 gauge).

Visualizing a nerve fully encompassed in an ice ball does not guarantee effective treatment, as temperatures within the ice ball may not reach the levels necessary to induce Wallerian degeneration, highlighting the need for further research to understand the implications for human tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relative Effects of Various Factors on Ice Ball Formation and Ablation Zone Size During Ultrasound-Guided Percutaneous Cryoneurolysis: A Laboratory Investigation to Inform Clinical Practice and Future Research. Said, ET., Marsh-Armstrong, BP., Fischer, SJ., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3718449/

Effectiveness of cryotherapy after anterior cruciate ligament ... Cryotherapy in the immediate postoperative period of ACL reconstruction was effective to improve pain and range of motion of the knee.

2. withpower.com withpower.com/trial/phase-acl-repair-10-2024-aff6e

Cryoneurolysis for ACL Reconstruction Trial Overview The study tests if applying extreme cold (Cryoneurolysis) to nerves around the knee before ACL surgery can reduce pain after the operation.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/15915833/

Cryotherapy after ACL reconstruction: a meta-analysis This meta-analysis showed that cryotherapy has a statistically significant benefit in postoperative pain control, while no improvement in postoperative range ...

4. worksafebc.com worksafebc.com/resources/health-care-providers/guides/efficacy-effectiveness-of-cold-compression-therapies-post-joint-surgery?lang=en&direct

Efficacy and Effectiveness of Cold-Compression Therapies ... The continuous outcomes without sufficient data for meta-analysis were the length of hospital stay, use of analgesic medication, edema, ROM, knee function, ...

5. thieme-connect.de thieme-connect.de/products/ejournals/abstract/10.1055/s-0030-1248169?device=desktop&innerWidth=412&offsetWidth=412

Cryotherapy After ACL Reconstruction – A Meta-analysis Single institutional randomized clinical trials have evaluated the efficacy of cryotherapy after arthroscopically-as-sisted anterior cruciate ...

6. researchgate.net researchgate.net/publication/7825597_Cryotherapy_After_ACL_Reconstruction_-_A_Meta-analysis

Cryotherapy After ACL Reconstruction - A Meta-analysis This meta-analysis showed that cryotherapy has a statistically significant benefit in postoperative pain control, while no improvement in postoperative range ...