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 @ 5:57 PM
Ignite Modification Date:
2025-12-24 @ 5:57 PM
NCT ID:
NCT05054868
Eligibility Criteria:
Inclusion Criteria:
* Age 18 - 75 years.
* Women of childbearing potential must have a negative serum or urine pregnancy test results within 24 hours before the first dose of ketorolac.
* Primary elective great toe MTP arthrodesis (CPT 28750). Other forefoot procedures often performed in conjunction with toe fusion will be included (CPT codes 28308, 28285, 28270).
Exclusion Criteria:
* Chronic pain syndrome, CRPS or fibromyalgia
* Revision procedures
* Use of allograft bone at the fusion site
* Tobacco use
* Diabetes
* Narcotic abuse or IV drug abuse
* Any CPT codes involving the midfoot, hindfoot, and/or ankle
* Unable to take NSAIDs secondary to medical comorbidities such as kidney disease (impaired renal function with CrCl ≤ 50 ml/min) or gastric ulcers
* Weight \< 50 kg
* Does not speak or read English
* If pregnant or planning to become pregnant or breastfeeding
* Non-independent dweller (prisoner)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05054868
Study Brief:
Protocol Section:
NCT05054868