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NCT Number: NCT06603051

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

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.

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Key information

Conditions

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virtua Orthopedics Burlington, Burlington, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Post-operative opioid consumption

    Time frame: Measured at 1-week, 6-weeks, 12-weeks

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

Secondary outcomes

  1. IKDC Subjective Knee Evaluation Form

    Time frame: 1-week, 6-week, 12-week postoperative period

    10-item self-rated scale measuring symptoms, athletic activity, and knee function.

Study contacts

Contact information is provided by the study sponsor or research team.

Sean Mc Millan, DO

CONTACT

[email protected]

(609)747-9200

Sponsors and collaborators

Lead sponsor

Virtua Health, Inc.

Other

Collaborators

  • Pacira Pharmaceuticals, Inc

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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