Cannulated Bone Bolt® Screw System Versus Standard Cannulated Screw System Fixation for Pelvic Fr… (NCT07209280) | Clinical Trial Compass
By InvitationNot Applicable
Cannulated Bone Bolt® Screw System Versus Standard Cannulated Screw System Fixation for Pelvic Fractures
United States100 participantsStarted 2025-06-11
Plain-language summary
The investigators aim is to determine if the cannulated Bone Bolt® screw system will provide improved post-operative pain control as compared to standard cannulated screw system fixation for the operative treatment of LC1 fractures (primary outcome). Hypothesis: Patients treated with the cannulated Bone Bolt® screw system will experience a clinically important difference (1.5 points) in post-operative pain as measured by the Visual Analog Scale (VAS) compared to patients treated with standard cannulated screw system fixation.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age at presentation between 18 and 80 years in line with literature from prior investigations.
* Operative LC1 pelvic ring injury.
* Glasgow Coma Scale of 15.
* Willingness to participate in study.
Exclusion Criteria:
* Inability to provide informed consent.
* Pregnant or lactating woman.
* Current incarceration.
* Associated spinal cord injury.
* Non-ambulatory patients (including patients with associated lower extremity fracture that may limit post-operative weight bearing).
* Patient presents with osteoporosis, which in the opinion of the Principal Investigator, may limit the subject's ability to support fracture repair using the study device.
* Patient has a metabolic disorder that may impair bone formation.
* Patient has osteomalacia.
* Patient has distant foci of infections which may spread to the implant site or patient with infection, sepsis or osteomyelitis.
* Patient has a vascular insufficiency, muscular atrophy, or neuromuscular disease.
* Patient is a current alcohol or drug abuser.
* Patients unable to comply with post-operative instruction.
* Other lower extremity injuries that impact weight bearing recommendation.
* Injuries that may have a larger impact on pain than the studied pelvic ring.
* Non-English/Spanish speaking.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.