MedTrace Logo

Cryoneurolysis in Anterior Cruciate Ligament Reconstruction (ACLR)

NCT07731178 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-07-28

No results posted yet for this study

Summary

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.

Conditions

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

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.

Sponsors & Collaborators

Principal Investigators

  • Eric J. Strauss, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-09-30
Completion
2028-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07731178 on ClinicalTrials.gov