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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT06256458
Eligibility Criteria:
Inclusion Criteria:
1. Subjects at least 18 years old at the time of injury
2. Acute fractures, resulting from blunt or penetrating trauma
* In the extremities or pelvis
* Requiring surgery
* Treated emergently, delayed or staged up to 4 weeks from the date of injury
* Where bone grafting is clinically indicated
Exclusion Criteria:
1. Certain fracture locations (these apply to non-unions as well)
* Hand - metacarpals, phalanges
* Forefoot - metatarsals, phalanges
* Skull
* Spine
2. Fractures requiring definitive fracture stabilization beyond the initial 4 weeks from the date of injury
3. Pathologic fractures secondary to malignancy
4. Subjects unable to follow recommended post-operative plan and complete follow ups
5. Subjects unable to complete patient reported outcome measures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06256458
Study Brief:
Protocol Section:
NCT06256458