Cannulated Bone Bolt® Screw System Versus Standard Cannulated Screw System Fixation for Lateral Compression Type-1 (Lc-1) Pelvic Ring Injuries: Multicenter Prospective Observational Study

Pelvic Ring Injury Surgery Study

D
Dillon O'Neill

Primary Investigator

Enrolling By Invitation
18 years - 80 years
All
Phase N/A
1 participants needed
1 Location

Brief description of study

The purpose of this study is to evaluate recovery and outcomes following cannulated Bone Bolt® screw system versus standard cannulated screw system fixation for LC-1 pelvic ring injuries. The devices being studied are not investigational and have been approved for use by the FDA. The study team is evaluating recovery and outcomes following surgical treatment of pelvic ring injuries.

THIS STUDY IS ENROLLING BY INVITATION ONLY - The orthopaedic trauma team meets every morning to discuss the patients under orthopaedic care. Patients identified to between 18 and 80 years with operative LC1 pelvic ring injury, will be screened for study enrollment at that meeting. Patients with qualifying injuries will be flagged as potential candidates and further medical record review will be conducted by the study team.

Detailed description of study

OtherCannulated Bone Bolt® Screw System

  • Patients treated with the Cannulated Bone Bolt® screw system for Lateral Compression Type -1 (LC-1) fractures.

OtherStandard Cannulated Screw System

  • Patients treated with the Standard Cannulated Screw System for Lateral Compression Type -1 (LC-1) fractures.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pelvic ring injury or fracture, post-operative pain
  • Age: 18 years - 80 years
  • Gender: All

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.

This study investigates the recovery and outcomes of two different surgical treatments for LC-1 pelvic ring injuries. LC-1 pelvic ring injuries are a type of fracture in the pelvis caused by lateral compression. The study compares the use of the Cannulated Bone Bolt screw system with the Standard Cannulated Screw system to see which is more effective in treating these injuries.

Participants will undergo surgery to fix their pelvic fractures using either the Cannulated Bone Bolt screw system or the Standard Cannulated Screw system. The study will observe the recovery process and outcomes after surgery to determine the effectiveness of each method.

  • Who can participate: Adults aged 18 to 80 with an LC-1 pelvic ring injury needing surgery may join. Key criteria include a Glasgow Coma Scale of 15 and willingness to participate.
  • Study details: Participants will have surgery with one of two screw systems for their pelvic injury. The study will monitor recovery and outcomes, and both treatments are FDA-approved devices.
Updated on 18 May 2026. Study ID: ORTHO-UU-BONE-BOLT, 29739
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only