Status:
ENROLLING_BY_INVITATION
Cannulated Bone Bolt® Screw System Versus Standard Cannulated Screw System Fixation for Pelvic Fractures
Lead Sponsor:
University of Utah
Conditions:
Pain
Eligibility:
All Genders
18-80 years
Brief 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 opera...
Detailed Description
Lateral Compression type-1 (LC1) fractures of the pelvis represent the most common injury to the pelvic ring, accounting for more than 50% of all pelvic ring injuries. These injuries occur secondary t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 11 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07209280
Start Date
June 11 2025
End Date
June 1 2028
Last Update
October 6 2025
Active Locations (1)
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1
University of Utah Orthopedics
Salt Lake City, Utah, United States, 84108