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:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT02818894
Eligibility Criteria:
Inclusion Criteria:
* Radiographic evidence of symptomatic osteoarthritis in one or bilateral hips. Osteoarthritis will be defined as pain with weight-bearing at the hip articulation together with radiographic findings
* Indicated for total hip arthroplasty
* Agreement to undergo spinal anesthesia for surgery
Exclusion Criteria:
* Patient refusal to undergo spinal anesthesia
* Patients with a known history of lumbar or sacral spinal fusion.
* Patients with a known history of prostate, urological, or kidney surgery.
* Patients who need monitoring of urine output during surgery (including patients with confirmed renal disease, renal failure, chronic renal insufficiency, or an indwelling catheter at the time of surgery).
* Current infection at site of injection
* Women of child-bearing potential who are on Medicare (child-bearing potential will be determined prior to surgery per Anesthesia standard of care)
* Hypovolemia
* Indeterminate neurologic disease
* Allergy or hypersensitivity to the study medications
* Currently taking any anti-coagulation medications or coagulopathic
* Increased intracranial pressure
* Subject is unable to make his/her own decision regarding the informed consent
* Subject is unable to read/understand English
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT02818894
Study Brief:
Protocol Section:
NCT02818894