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

Last updated: January 20, 2025
Sponsor: Virtua Health, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Cryoneurolysis

Clinical Study ID

NCT06603051
G24064
CON-000367
  • Ages > 14
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Cryoneurolysis
Phase:
Study Start date:
August 28, 2024
Estimated Completion Date:
February 28, 2026

Connect with a study center

  • Virtua Orthopedics Burlington

    Burlington, New Jersey 08016
    United States

    Active - Recruiting

  • Virtua Orthopedics Cherry Hill

    Cherry Hill, New Jersey 08034
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.