Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07731178

Cryoneurolysis in Anterior Cruciate Ligament Reconstruction (ACLR)

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

ACL Reconstruction (ACLR) With a Bone-patellar Tendon-bone (BPTB) Autograft

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Pacira Iovera Cryoneurolysis device

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.

Placebo/Sham device

Device

The placebo/sham device looks just like the ioveraº device, but does not contain cyoneurolysis or any treatment.

Primary outcomes

  1. Difference in Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: Baseline, 1 Month

    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.

  2. Difference in Lysholm knee scoring scale (LKSS)

    Time frame: Baseline, 1 Month

    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.

Secondary outcomes

  1. Change in Visual Analogue Scale (VAS) for Pain score

    Time frame: Baseline, Post-operative Day 1

    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.

  2. Change in Visual Analogue Scale (VAS) for Pain score

    Time frame: Baseline, Week 3

    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.

  3. Change in Visual Analogue Scale (VAS) for Pain score

    Time frame: Baseline, Month 6

    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.

  4. Change in Numeric Rating Scale (NRS)

    Time frame: Baseline, Post-operative Day 1

    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"

  5. Change in Numeric Rating Scale (NRS)

    Time frame: Baseline, Week 3

    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"

  6. Change in Numeric Rating Scale (NRS)

    Time frame: Baseline, Month 6

    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"

  7. Cumulative opioid consumption as measured by morphine milligram equivalents (MME)

    Time frame: Up to 21 days post-operative

Study contacts

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

Eric J. Strauss, MD

CONTACT

[email protected]

646-501-7208

Layne Estes

CONTACT

[email protected]

646-501-7208

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 28, 2026
Registry last updated
Jul 28, 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.