Cryoneurolysis in Anterior Cruciate Ligament Reconstruction (ACLR)

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 45 Years

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

First listed

Jul 28, 2026

Start date

Aug 31, 2026

Status verified

Jul 2026

Primary completion

Sep 30, 2027

Completion

Aug 31, 2028

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ioveraº cryoneurolysis study group
  Participants will receive the ioveraº cryoneurolysis intervention before surgery.
• Sham Comparator: Placebo study group
  Participants will have a sham intervention that does not have cryoneurolysis before surgery.

Primary Outcome Measure

Difference in Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Baseline, 1 Month ]

Central Contacts

• Layne Estes
  646-501-7208
  [email protected]
• Eric J. Strauss, MD
  646-501-7208
  [email protected]

Locations (1)

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