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 @ 3:00 PM
Ignite Modification Date:
2025-12-24 @ 3:00 PM
NCT ID:
NCT05327959
Eligibility Criteria:
Inclusion Criteria:
* Patient must be 18 years of age or older.
* Patient must have a clavicle fracture requiring surgical intervention and be eligible for fixation by locking plate and screws.
* Unilateral or Bilateral fractures.
* Patient must be capable of understanding the doctor's explanation, following doctor's instruction, is able to and willing to complete the protocol required follow-up.
* Patient must have a signed IRB/EC approved informed consent.
Exclusion Criteria:
* Active infection.
* Patients presenting conditions including blood supply limitations, insufficient quantity or quality of bone.
* Patients with mental or neurologic conditions who are unwilling or incapable of giving proper informed consent, following postoperative care instructions.
* Foreign body sensitivity where material sensitivity is suspected, testing is to be completed prior to implantation of the device.
* Patient is a current alcohol or drug abuser
* Patient is a prisoner
* Patient known to be pregnant or breast feeding
* Likely problems with maintaining follow-up program (e.g. patient with no fixed address, long distance, plans to move during course of study)
* Not expected to survive the duration of the follow-up program
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05327959
Study Brief:
Protocol Section:
NCT05327959