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NCT07731178
Cryoneurolysis in Anterior Cruciate Ligament Reconstruction (ACLR)
Conditions: ACL Reconstruction (ACLR) With a Bone-patellar Tendon-bone (BPTB) Autograft
Sex: All
Ages: 18 Years – 45 Years
Healthy volunteers: No
Phase: NA
Enrollment: 150
Sponsor: NYU Langone Health
Location: NYU Langone Health New York New York
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07731178). StuddyBuddy aggregates publicly available trial information.