Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT06340932
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 15 years or older at screening.
* Primary diagnosis of ACL injury as evidenced by MRI or similar imaging study and are scheduled to undergo ACLR with or without meniscal repair/meniscectomy
* Non-pregnant patients with verbal confirmation that they are not planning to become pregnant during the study period.
i. Female subjects must have a confirmatory negative pregnancy test as part of the routine pre-operative laboratory testing ii. Subjects must endorse a plan to utilize contraceptives (condoms, hormonal birth control, IUD, etc.) for any sexual activity during the study period.
* English speaking patients
* Provision of informed consent with ability to adhere to the study visit schedule and complete all study assessments.
Exclusion Criteria:
* Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications
* History of contralateral ACL repair within 1 year of screening
* Multi-ligament injury requiring reconstruction
* Inability to return to the study doctor's clinic for postoperative visits
* Pregnant or trying to become pregnant
* Breastfeeding
* Have a severe chronic pain condition that in the opinion of the study doctor may impact post-surgical outcomes of analgesic and opioid usage (i.e., fibromyalgia, cancer, sickle cell disease)
* Have a known contraindication to the iovera° device, including any of the following:
i. Cryoglobulinemia (presence of abnormal proteins in the blood that thicken in cold temperatures) ii. Paroxysmal cold hemoglobinuria (an autoimmune disorder where cold-reacting antibodies that attack and destroy red blood cells) iii. Cold urticaria (temporary itchy welts \[hives\] on skin exposed to cold temperatures) iv. Raynaud's disease (which causes some areas of the body, such as fingers and toes, to feel numb and cold in response to cold temperatures) v. Open and/or infected wounds at or near the study treatment site vi. Coagulopathy (problems with blood clotting)
* Have poorly controlled mental illness that in the opinion of the study doctor may meaningfully impact study treatment outcomes, including any of the following:
i. Mood disorder (for example, major depression, bipolar) ii. Psychotic disorder (for example, schizophrenia)
* Have a history, suspicion, or clinical manifestation of:
i. Alcohol abuse or dependence ii. Illicit drug use iii. Opioid abuse or dependence (greater than or equal to 40 mg morphine equivalent dose by mouth per day in the past 30 days)
* Pregnant or planning to become pregnant during the study period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT06340932
Study Brief:
Protocol Section:
NCT06340932