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 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
NCT ID:
NCT02625766
Eligibility Criteria:
Inclusion Criteria:
* The patient has one of the following pelvic fractures (includes bilateral sacral fractures): Lateral compression type 1, Lateral compression type 2, Lateral compression type 3
* The patient is between 18 and 80 years of age, inclusive
* The patient has reached skeletal maturity
* The patient's pelvic fracture is a result of trauma (includes polytraumatized patients)
* The patient/family/guardian is English-speaking
* The patient's surgeon agrees to randomization (the patient is amendable to either operative or non-operative treatment)
* Patient enrollment and, if applicable, patient randomization can occur within 96 hours post injury
Exclusion Criteria:
* The patient has prior surgical hardware in place that precludes intervention
* The patient's pelvic fracture is classified as a Lateral compression type 1 and the associated sacral fracture is incomplete as indicated by failure to violate both the anterior and posterior cortex
* The patient received prior surgical intervention for his/her current pelvic injury
* The patient has sacral morphology that precludes percutaneous fixation
* The patient is non-ambulatory due to an associated spinal cord injury
* The patient was non-ambulatory pre-injury
* The patient is currently pregnant
* The patient is enrolled in another research study that does not allow co-enrollment
* The patient is likely to have severe problems with maintaining follow-up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02625766
Study Brief:
Protocol Section:
NCT02625766