Cryoneurolysis in Anterior Cruciate Ligament Reconstruction (ACLR)

Evaluating the Efficacy of Preoperative Cryoneurolysis With Iovera on Postoperative Pain, Function, and Opioid Use Following ACL Reconstruction With Bone-Patellar Tendon-Bone Autograft

The purpose of this research study is to assess whether cryoneurolysis will help control pain after ACLR surgery and decrease the need of opioid medications. The primary objective is to compare postoperative functional recovery between Iovera and sham arms at 1 month after ACLR.

Study Overview

• Status: Not yet recruiting
• Conditions: ACL Reconstruction (ACLR) With a Bone-patellar Tendon-bone (BPTB) Autograft
• Intervention / Treatment: Device: Pacira Iovera Cryoneurolysis device; Device: Placebo/Sham device

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Layne Estes; Phone Number: 646-501-7208; Email: Layne.estes@nyulangone.org
• Study Contact Backup: Name: Eric J. Strauss, MD; Phone Number: 646-501-7208; Email: Eric.strauss@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18-45 years
2. Scheduled for primary ACLR with BPTB autograft
3. Willingness and ability to participate in Iovera
4. No chronic opioid use preoperatively
5. No known neurologic disorders affecting the lower extremity
6. Capacity and willingness to provide informed consent and comply with follow-up schedules

Exclusion Criteria:

1. Prior surgery on the affected knee.
2. Non-English speaking if validated PRO instruments at the site are only available in English; include validated translations if available and approved.
3. Contraindications to cryoneurolysis (e.g., cryoglobulinemia, cold urticaria, Raynaud's phenomenon, paroxysmal cold hemoglobinuria) or to local anesthetics.
4. Active skin infection, dermatitis, or compromised skin integrity at or near treatment sites.
5. Bleeding diathesis or anticoagulant therapy not compatible with minor percutaneous procedures per institutional policy.
6. Pregnancy or breastfeeding.
7. Known peripheral neuropathy or significant sensory deficit of the target region.
8. Any condition that, in the investigator's judgment, increases risk or interferes with participation
9. Concomitant use of other opioid drugs or prior chronic use.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ioveraº cryoneurolysis study group; Participants will receive the ioveraº cryoneurolysis intervention before surgery.	Device: Pacira Iovera Cryoneurolysis device; The device includes a hand-held piece, charging port with cord, and disposable components: the nitrous oxide capsule and a small probe called the Smart Tip, which has needles that administer the cold to the nerve. It works immediately by freezing nerves that transmit pain signals to reduce pain transmission after surgery.
Sham Comparator: Placebo study group; Participants will have a sham intervention that does not have cryoneurolysis before surgery.	Device: Placebo/Sham device; The placebo/sham device looks just like the ioveraº device, but does not contain cyoneurolysis or any treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Knee Injury and Osteoarthritis Outcome Score (KOOS)	The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.	Baseline, 1 Month
Difference in Lysholm knee scoring scale (LKSS)	The Lysholm knee scoring scale is a 100-point patient-reported questionnaire designed to assess functional knee ligament injuries. It evaluates eight areas - limp, support, locking, instability, pain, swelling, stair climbing, and squatting - with higher scores (up to 100) indicating better function.	Baseline, 1 Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Analogue Scale (VAS) for Pain score	VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.	Baseline, Post-operative Day 1
Change in Visual Analogue Scale (VAS) for Pain score	VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.	Baseline, Week 3
Change in Visual Analogue Scale (VAS) for Pain score	VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.	Baseline, Month 6
Change in Numeric Rating Scale (NRS)	A segmented, numbered version of the VAS. Patients select a whole number from 0 to 10 where 0 is "no pain" and 10 is the "worst pain imaginable"	Baseline, Post-operative Day 1
Change in Numeric Rating Scale (NRS)	A segmented, numbered version of the VAS. Patients select a whole number from 0 to 10 where 0 is "no pain" and 10 is the "worst pain imaginable"	Baseline, Week 3
Change in Numeric Rating Scale (NRS)	A segmented, numbered version of the VAS. Patients select a whole number from 0 to 10 where 0 is "no pain" and 10 is the "worst pain imaginable"	Baseline, Month 6
Cumulative opioid consumption as measured by morphine milligram equivalents (MME)		Up to 21 days post-operative

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Eric J. Strauss, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: July 23, 2026
• First Submitted That Met QC Criteria: July 23, 2026
• First Posted (Actual): July 28, 2026

Study Record Updates

• Last Update Posted (Actual): July 28, 2026
• Last Update Submitted That Met QC Criteria: July 23, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: ACLR
• Other Study ID Numbers: 25-00771

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a single-site device study. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to layne.estes@nyulangone.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes