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

Not Applicable

Recruiting

• Conditions: ACL Repair
• Interventions: Procedure: Cryoneurolysis

• Registration Number: NCT06603051
• Lead Sponsor: Virtua Health, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-28
• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-16
• Study First Posted: 2024-09-19
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-22
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B: Usual care plus pre-operative cryoneurolysis	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 Measures

Name	Time	Method
Post-operative opioid consumption	Measured at 1-week, 6-weeks, 12-weeks	average daily morphine milliequivalents (MMEs) over the measured postoperative period

Secondary Outcome Measures

Name	Time	Method
IKDC Subjective Knee Evaluation Form	1-week, 6-week, 12-week postoperative period	10-item self-rated scale measuring symptoms, athletic activity, and knee function.

Trial Locations

Locations (2)

Virtua Orthopedics Burlington; 🇺🇸 Burlington, New Jersey, United States

Virtua Orthopedics Cherry Hill; 🇺🇸 Cherry Hill, New Jersey, United States