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 — OTHER
    Patients treated with the Cannulated Bone Bolt® screw system for Lateral Compression Type -1 (LC-1) fractures.
  • Standard Cannulated Screw System — OTHER
    Patients 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 System
    Surgeons 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 Fixation
    Surgeons 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)

FacilityCityStateZIPSite coordinators
University of Utah OrthopedicsSalt Lake CityUtah84108-

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