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

NCT06603051 | Recruiting FDA Device

• 2 other identifiers: G24064CON-000367
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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). 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

Keywords

ACL Repair; Cryoneurolysis

Outcome Measures

Primary Outcomes (1)

• Post-operative opioid consumption

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

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

Secondary Outcomes (1)

• IKDC Subjective Knee Evaluation Form

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

Study Arms (2)

Arm A: ACL reconstruction usual care

NO 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.

Arm B: Usual care plus pre-operative cryoneurolysis

EXPERIMENTAL

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).

Procedure: Cryoneurolysis

Interventions

Cryoneurolysis PROCEDURE

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).

Arm B: Usual care plus pre-operative cryoneurolysis

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Virtua Health, Inc.: lead
• Pacira Pharmaceuticals, Inc: collaborator

Study Sites (2)

Virtua Orthopedics Burlington

Burlington, New Jersey, 08016, United States

RECRUITING

Virtua Orthopedics Cherry Hill

Cherry Hill, New Jersey, 08034, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 36143381 BACKGROUND

• 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.

  PMID: 26135702 BACKGROUND

• 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.

  PMID: 27333989 BACKGROUND

• 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.

  PMID: 26875052 BACKGROUND

• 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.

  PMID: 28336454 RESULT

• 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.

  PMID: 33279353 RESULT

Central Study Contacts

Sean Mc Millan, DO

CONTACT

(609)747-9200; smcmillan@virtua.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: August 28, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)