Cannulated Bone Bolt® Screw System Versus Standard Cannulated Screw System Fixation for Pelvic Fractures
Part of paid clinical trials in Salt Lake City, Utah.
- Sponsor
- University of Utah
- Study ID
- NCT07209280
- Status
- Enrolling By Invitation
Conditions
- Pain
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Cannulated Bone Bolt® Screw System — OTHERPatients treated with the Cannulated Bone Bolt® screw system for Lateral Compression Type -1 (LC-1) fractures.
- Standard Cannulated Screw System — OTHERPatients treated with the Standard Cannulated Screw System for Lateral Compression Type -1 (LC-1) fractures.
Study Details
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.
Key Dates
- Start date
- Jun 11, 2025
- Status verified
- Apr 2026
- Primary completion
- Jun 30, 2028
- Completion
- Jun 30, 2028
Study Design
- Enrollment
- 100 participants (estimated)
Arms
- Arm: Cannulated Bone Bolt® Screw SystemSurgeons identifying as users of the Cannulated Bone Bolt® screws will be required to place at least one Cannulated Bone Bolt® screw in each of their operative LC1 injuries.
- Arm: Standard Cannulated Screw System FixationSurgeons identifying as users of standard cannulated screws will be able to use the cannulated screw of their choice.
Primary Outcome Measure
Visual Analog Scale (VAS) pain [ Time Frame: 2-weeks after surgery ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Utah Orthopedics | Salt Lake City | Utah | 84108 | - |
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