Actively Recruiting

Phase Not Applicable
Age: 14Years +
All Genders
NCT06603051

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

Led by Virtua Health, Inc. · Updated on 2026-05-12

20

Participants Needed

2

Research Sites

161 weeks

Total Duration

On this page

Sponsors

V

Virtua Health, Inc.

Lead Sponsor

P

Pacira Pharmaceuticals, Inc

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 14Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 nafve
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Virtua Orthopedics Burlington

Burlington, New Jersey, United States, 08016

Actively Recruiting

2

Virtua Orthopedics Cherry Hill

Cherry Hill, New Jersey, United States, 08034

Actively Recruiting

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Research Team

S

Sean Mc Millan, DO

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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