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Not yet recruiting NCT07731178

Cryoneurolysis in Anterior Cruciate Ligament Reconstruction (ACLR)

No phase Interventional ACL Reconstruction (ACLR) With a Bone-patellar Tendon-bone (BPTB) Autograft

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pacira Iovera Cryoneurolysis device, Placebo/Sham device.
Who it may be relevant to
Registry conditions: ACL Reconstruction (ACLR) With a Bone-patellar Tendon-bone (BPTB) Autograft. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Interventions

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

Primary outcome measures

  • Difference in Knee Injury and Osteoarthritis Outcome Score (KOOS) [Time frame: Baseline, 1 Month]
  • Difference in Lysholm knee scoring scale (LKSS) [Time frame: Baseline, 1 Month]
Secondary outcome measures (7)
  • Change in Visual Analogue Scale (VAS) for Pain score [Time frame: Baseline, Post-operative Day 1]
  • Change in Visual Analogue Scale (VAS) for Pain score [Time frame: Baseline, Week 3]
  • Change in Visual Analogue Scale (VAS) for Pain score [Time frame: Baseline, Month 6]
  • Change in Numeric Rating Scale (NRS) [Time frame: Baseline, Post-operative Day 1]
  • Change in Numeric Rating Scale (NRS) [Time frame: Baseline, Week 3]
  • Change in Numeric Rating Scale (NRS) [Time frame: Baseline, Month 6]
  • Cumulative opioid consumption as measured by morphine milligram equivalents (MME) [Time frame: Up to 21 days post-operative]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT07731178 · 25-00771

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗