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

DO

Dillon O'Neill

Principal Investigator

Status: Enrolling By Invitation Ages: 18 Years - 80 Years Gender: All Genders Phase: N/A 1 Locations

Brief Description

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

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

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.

Interested in participating?

Enrollment in IU School of Medicine clinical trials is managed through our All IN for Health program. Visit allinforhealth.info to see if you're eligible and join the study.