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ACL RepairNCT06603051

The Effect of Pre-Operative Cryoneurolysis on Post-Operative Narcotic Consumption in Patients Undergoing Autograft ACL Reconstruction

A study testing Cryoneurolysis in people with ACL Repair, run by Virtua Health, Inc. at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of the research is to investigate the effect of preoperative Cryoneurolysis of the knee on postoperative pain management in patients undergoing autograft anterior cruciate ligament (ACL) reconstruction (a surgical procedure that makes a new ACL using the patient's own tendon). Read more about this study

Who is it for?
Ages 14 years and older
Conditions the study is for
ACL Repair
What is being tested?
Cryoneurolysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesUnited States
Study dates
28 Aug 2024to Oct 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 14 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • - Patients aged 14 and over
  • Patients who are patients within the PI's practice
  • Patients who can speak and read English
  • Patients undergoing autograft ACL reconstruction.
  • Patients who are opioid naïve

Who cannot join

  • - Under the age of 14
  • Non-English speaking/reading patients
  • Patients with Reynauds' syndrome
  • Patients with skin disorders or hypo-vascularity
  • Patients undergoing allograft ACL reconstruction.
  • Patients who consistently use opioids preoperatively

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sean Mc Millan, DO contact

(609)747-9200

smcmillan@virtua.org

United States2 sites, 2 recruiting

  • Virtua Orthopedics Burlington

    Burlington, New Jersey, 08016

    Sean Mc Millan, DO, (609)747-9200, smcmillan@virtua.org

    Sean Mc Millan, DO

    Recruiting

  • Virtua Orthopedics Cherry Hill

    Cherry Hill, New Jersey, 08034

    Sean Mc Millan, DO, (609)747-9200, smcmillan@virtua.org

    Recruiting

Other trials in United States

About this study

The purpose of the research is to investigate the effect of preoperative Cryoneurolysis of the knee on postoperative pain management in patients undergoing autograft anterior cruciate ligament (ACL) reconstruction (a surgical procedure that makes a new ACL using the patient's own tendon). Cryoneurolysis is an approved process of applying extreme cold temperatures to targeted nerves in order to decrease or eliminate pain. . If you take part in the research, you will be randomly assigned (assigned by chance, like a flip of a coin) to Group A (standard care) or Group B (standard care plus Cryoneurolysis). Participants in both groups will undergo standard ACL reconstruction and receive standard preoperative and postoperative pain management. Participants in Group B only will also receive a standard treatment of Cryoneurolysis to their surgical knee within 7-10 days before their scheduled surgery. Participants in both groups (A \& B) will be asked to bring their remaining postoperative pain medication to their postoperative follow-up appointments for review by study personnel. Participants will also be asked to complete a survey about their knee activity, function and symptoms at these appointments. Your time in the study will last until the completion of the 12-week postoperative follow-up appointment.

Conditions
ACL Repair
Being tested
Cryoneurolysis
Keywords
ACL Repair, Cryoneurolysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CryoneurolysisProcedure or surgery

    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).

Study groups in NCT06603051
Study groupRoleWhat they receive
Arm A: ACL reconstruction usual careNo interventionOn 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.
Arm B: Usual care plus pre-operative cryoneurolysisExperimentalThose 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).
Receives: Procedure: Cryoneurolysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post-operative opioid consumption

    average daily morphine milliequivalents (MMEs) over the measured postoperative period

    Measured: Measured at 1-week, 6-weeks, 12-weeks

Secondary outcomes (1)

  1. IKDC Subjective Knee Evaluation Form

    10-item self-rated scale measuring symptoms, athletic activity, and knee function.

    Measured: 1-week, 6-week, 12-week postoperative period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start28 Aug 2024
  3. Primary completionApr 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06603051
Sponsor's protocol ID
G24064
Other IDs
CON-000367
Status last verified
May 2026
First submitted
10 Sep 2024
Last updated
12 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Will share aggregate data only

Publications

  • Lung BE, Karasavvidis T, Sharma AK, Amirhekmat A, Stepanyan H, McMaster W, Yang S, So DH. Cryoneurolysis Is a Safe, Effective Modality to Improve Rehabilitation after Total Knee Arthroplasty. Life (Basel). 2022 Aug 29;12(9):1344. doi: 10.3390/life12091344.

    PubMed 36143381

  • Kapadia BH, Berg RA, Daley JA, Fritz J, Bhave A, Mont MA. Periprosthetic joint infection. Lancet. 2016 Jan 23;387(10016):386-394. doi: 10.1016/S0140-6736(14)61798-0. Epub 2015 Jun 28.

    PubMed 26135702

  • Ilfeld BM, Preciado J, Trescot AM. Novel cryoneurolysis device for the treatment of sensory and motor peripheral nerves. Expert Rev Med Devices. 2016 Aug;13(8):713-25. doi: 10.1080/17434440.2016.1204229. Epub 2016 Jul 13.

    PubMed 27333989

  • Dasa V, Lensing G, Parsons M, Harris J, Volaufova J, Bliss R. Percutaneous freezing of sensory nerves prior to total knee arthroplasty. Knee. 2016 Jun;23(3):523-8. doi: 10.1016/j.knee.2016.01.011. Epub 2016 Feb 10.

    PubMed 26875052

  • Radnovich R, Scott D, Patel AT, Olson R, Dasa V, Segal N, Lane NE, Shrock K, Naranjo J, Darr K, Surowitz R, Choo J, Valadie A, Harrell R, Wei N, Metyas S. Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial. Osteoarthritis Cartilage. 2017 Aug;25(8):1247-1256. doi: 10.1016/j.joca.2017.03.006. Epub 2017 Mar 20.

    PubMed 28336454

  • Mihalko WM, Kerkhof AL, Ford MC, Crockarell JR Jr, Harkess JW, Guyton JL. Cryoneurolysis before Total Knee Arthroplasty in Patients With Severe Osteoarthritis for Reduction of Postoperative Pain and Opioid Use in a Single-Center Randomized Controlled Trial. J Arthroplasty. 2021 May;36(5):1590-1598. doi: 10.1016/j.arth.2020.11.013. Epub 2020 Nov 14.

    PubMed 33279353

Questions about this trial

What is this clinical trial studying?

A study testing Cryoneurolysis in people with ACL Repair, run by Virtua Health, Inc. at 2 sites 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 5 inclusion and 6 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 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 Sean Mc Millan, DO ((609)747-9200, smcmillan@virtua.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-operative opioid consumption (time frame: Measured at 1-week, 6-weeks, 12-weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06603051, which also lists 6 linked publications.

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 12 May 2026.

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