Recruiting

Cryoneurolysis

Sponsor:

Virtua Health, Inc.

Code:

NCT06603051

Conditions

ACL Repair

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Not accepted

Interventions

Cryoneurolysis

Study Details

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

Study ID

NCT06603051

Start date

Aug 28, 2024

Status verified date

May, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • \- 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

Exclusion Criteria:

  • \- 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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Arm A: ACL reconstruction usual care

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.

experimental: Arm B: Usual care plus pre-operative cryoneurolysis

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).

Interventions

Cryoneurolysis

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).

Primary outcome measure

  • Post-operative opioid consumption [ Time Frame: Measured at 1-week, 6-weeks, 12-weeks ]

Central Contacts and Locations

Central contacts

Sean Mc Millan, DO

(609)747-9200smcmillan@virtua.org

Locations

Virtua Orthopedics Burlington

Recruiting

Burlington, New Jersey, United States, 08016

Contacts

Sean Mc Millan, DO

(609)747-9200smcmillan@virtua.org

Principal Investigator:

Sean Mc Millan, DO

Virtua Orthopedics Cherry Hill

Recruiting

Cherry Hill, New Jersey, United States, 08034

Contacts

Sean Mc Millan, DO

(609)747-9200smcmillan@virtua.org

More Information

Sponsor

Virtua Health, Inc.

Last update posted

May 12, 2026

Last verified

May, 2026

Keywords

  • ACL Repair
  • Cryoneurolysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virtua Health, Inc. on 2026-05-12.