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 @ 4:07 PM
Ignite Modification Date:
2025-12-24 @ 4:07 PM
NCT ID:
NCT05669066
Eligibility Criteria:
Inclusion Criteria:
* • Male and female, ages 18-89 years
* Narcotic naive patients ("Narcotic naïve" for the purpose of this study will be no history of narcotic tolerance prior to surgery, defined by the FDA as greater than or equal to 60mg oral morphine equivalents per day for 7 days or longer)
* Scheduled for primary total knee replacement for osteoarthritis
* Willing to sign informed consent form
Exclusion Criteria:
* • Surgery to be performed for other disease entities (e.g., inflammatory arthritis, post septic arthritis, posttraumatic arthritis or acute fracture)
* History of narcotic tolerance prior to surgery (defined by the FDA as greater than or equal to 60mg oral morphine equivalents per day for 7 days or longer)
* Currently taking non-narcotic analgesics other than acetaminophen and non-steroidal anti-inflammatory medications (e.g. Tramadol)
* History of pain syndromes (e.g., fibromyalgia, complex regional pain syndrome, chronic low back pain)
* Dementia or other disorder of cognitive function that precludes study consent and/or participation in the MM program
* In investigator's opinion, unable to complete study tasks over 12-month follow-up period
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT05669066
Study Brief:
Protocol Section:
NCT05669066