[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07731178":3,"trial-entities:NCT07731178":98,"trial-summary:NCT07731178":102},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":41,"secondary_outcomes":49,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":69,"eligibility_criteria":70,"std_ages":74,"locations":76,"central_contacts":84,"overall_officials":93,"references":96,"see_also_links":97},"NCT07731178","25-00771","Cryoneurolysis in Anterior Cruciate Ligament Reconstruction (ACLR)","Evaluating the Efficacy of Preoperative Cryoneurolysis With Iovera on Postoperative Pain, Function, and Opioid Use Following ACL Reconstruction With Bone-Patellar Tendon-Bone Autograft","NOT_YET_RECRUITING","2028-08","2026-07","2026-07-28","2026-08","NYU Langone Health","OTHER",true,"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.",null,[19],"ACL Reconstruction (ACLR) With a Bone-patellar Tendon-bone (BPTB) Autograft",[21],"ACLR","INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},150,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"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.",[35],"Ioveraº cryoneurolysis study group",{"type":31,"name":37,"description":38,"armGroupLabels":39},"Placebo\u002FSham device","The placebo\u002Fsham device looks just like the ioveraº device, but does not contain cyoneurolysis or any treatment.",[40],"Placebo study group",[42,46],{"measure":43,"description":44,"timeFrame":45},"Difference in Knee Injury and Osteoarthritis Outcome Score (KOOS)","The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function\u002Fdaily living (17 questions), function\u002Fsports 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\u002F higher difficulty in function.","Baseline, 1 Month",{"measure":47,"description":48,"timeFrame":45},"Difference in Lysholm knee scoring scale (LKSS)","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.",[50,54,56,58,61,62,63],{"measure":51,"description":52,"timeFrame":53},"Change in Visual Analogue Scale (VAS) for Pain score","VAS is a tool widely used to measure pain. A patient is asked to indicate his\u002Fher 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.","Baseline, Post-operative Day 1",{"measure":51,"description":52,"timeFrame":55},"Baseline, Week 3",{"measure":51,"description":52,"timeFrame":57},"Baseline, Month 6",{"measure":59,"description":60,"timeFrame":53},"Change in Numeric Rating Scale (NRS)","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\"",{"measure":59,"description":60,"timeFrame":55},{"measure":59,"description":60,"timeFrame":57},{"measure":64,"timeFrame":65},"Cumulative opioid consumption as measured by morphine milligram equivalents (MME)","Up to 21 days post-operative","ALL","18 Years","45 Years",false,{"inclusion":71,"exclusion":72,"raw_text":73},[],[],"Inclusion Criteria:\n\n1. Age 18-45 years\n2. Scheduled for primary ACLR with BPTB autograft\n3. Willingness and ability to participate in Iovera\n4. No chronic opioid use preoperatively\n5. No known neurologic disorders affecting the lower extremity\n6. Capacity and willingness to provide informed consent and comply with follow-up schedules\n\nExclusion Criteria:\n\n1. Prior surgery on the affected knee.\n2. Non-English speaking if validated PRO instruments at the site are only available in English; include validated translations if available and approved.\n3. Contraindications to cryoneurolysis (e.g., cryoglobulinemia, cold urticaria, Raynaud's phenomenon, paroxysmal cold hemoglobinuria) or to local anesthetics.\n4. Active skin infection, dermatitis, or compromised skin integrity at or near treatment sites.\n5. Bleeding diathesis or anticoagulant therapy not compatible with minor percutaneous procedures per institutional policy.\n6. Pregnancy or breastfeeding.\n7. Known peripheral neuropathy or significant sensory deficit of the target region.\n8. Any condition that, in the investigator's judgment, increases risk or interferes with participation\n9. Concomitant use of other opioid drugs or prior chronic use.",[75],"ADULT",[77],{"facility":13,"city":78,"state":78,"zip":79,"country":80,"geoPoint":81},"New York","10016","United States",{"lat":82,"lon":83},40.71427,-74.00597,[85,90],{"name":86,"role":87,"phone":88,"email":89},"Layne Estes","CONTACT","646-501-7208","Layne.estes@nyulangone.org",{"name":91,"role":87,"phone":88,"email":92},"Eric J. Strauss, MD","Eric.strauss@nyulangone.org",[94],{"name":91,"affiliation":13,"role":95},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":99,"biomarkers":101},[100],"Anterior Cruciate Ligament Reconstruction",[],{"nct_id":4,"found":15,"summary":103,"prompt_version":113},{"design":104,"status":105,"heading":106,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This is an interventional study planning to enroll 150 participants. It compares the Pacira Iovera Cryoneurolysis device to a placebo\u002Fsham device.","completed","Cryoneurolysis for Pain After ACL Reconstruction","This study is looking at whether a treatment called cryoneurolysis (using cold to block nerves) can help reduce pain and the need for opioid medications after anterior cruciate ligament (ACL) reconstruction surgery. You might be eligible if you are between 18 and 45 years old, are having your first ACL reconstruction with a specific type of graft (bone-patellar tendon-bone autograft), and haven't used opioids long-term before surgery. The study will compare the Pacira Iovera Cryoneurolysis device to a sham device that looks the same but doesn't provide treatment. Researchers will measure your knee function and recovery one month after surgery to see if the cryoneurolysis treatment is helpful. The current status of this study is unclear.","Participants will be followed for at least one month after surgery to assess knee function.",116,"Not specified in the trial record.","Not stated in the trial record.",[32],"v2"]