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 @ 4:26 PM
Ignite Modification Date:
2025-12-24 @ 4:26 PM
NCT ID:
NCT06807866
Eligibility Criteria:
Inclusion Criteria:
* Patients \> 18 years of age
* Patients undergoing primary total hip arthroplasty
* Ambulatory patient prior to fracture
* Subjects must be capable of providing informed consent
* English or Spanish speaking
Exclusion Criteria:
* Previous hemiarthroplasty or THA on ipsilateral hip
* History of Complex Regional Pain Syndrome in ipsilateral extremity
* History of demyelinating disorder or neurologic deficit that may contribute to altered pain tolerance or sensation
* Acute or chronic hip infection in ipsilateral extremity
* Pregnant or breastfeeding
* Open fracture
* Polytrauma
* Intravenous or drug users within 6 months of surgery
* Liver Failure via clinical diagnosis or international normalized ratio greater than 1.5 or partial thromboplastin time greater than 40
* Patients on selective serotonin reuptake inhibitor, serotonin norepinephrine reuptake inhibitor, monoamine oxidase inhibitor, and/or tricyclic anti-depressant
* Severe renal dysfunctions, such as glomerular filtration rate less than 30
* Moderate to severe depression as diagnosed by a clinician
* Taking cytochrome P450 1A2 inhibitors and cytochrome P450 1A6 inhibitors for the duration of 5 half-lives as these drugs are clinically eliminated within 5 half-lives
* History of uncontrolled narrow angle glaucoma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06807866
Study Brief:
Protocol Section:
NCT06807866