RECRUITING

Geriatric Lateral Compression 1 Pelvic Fractures

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Lateral compression-1 (LC1) pelvic ring fragility fractures cause significant pain and morbidity. These fragility injuries are associated with prolonged immobility and long hospital stays. Currently there is no consensus on operative stabilization of LC1 pelvic fractures, nor are there evidence-based guidelines to aid in management of these injury types. Furthermore, there is variability in operative indications, improvement in pain and mobilization. The purpose of this study is to compare percutaneous screw fixation to non-operative management in symptomatic LC1 fragility fractures in elderly patients.

Official Title

Percutaneous Screw Fixation for Operative Treatment Versus Non-Operative Treatment of Geriatric Lateral Compression 1 Pelvic Fractures - A Randomized Controlled Trial

Quick Facts

Study Start:2023-05-05
Study Completion:2026-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05765669

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients \>/= 60 years of age
  2. * Lateral compression 1 pelvic ring fractures confirmed with plain radiographs, CT and/or MRI
  3. * Low energy mechanism of injury or an insufficiency fracture without a precipitating event
  4. * Acute injury within four weeks of presentation
  5. * Inability or significant pain to mobilize with physical therapy assistance for 48 hours: Significant pain as determined by a pain score ≥ 7 with the Visual Analogue Scale (VAS) after a Timed "Up \& Go" (TUG) assessment, or inability to complete the TUG assessment.
  1. * Dementia
  2. * Vertically or rotationally unstable pelvic ring injuries
  3. * Pathologic fracture secondary to tumor
  4. * Non-ambulatory prior to injury
  5. * Acute neurologic deficit
  6. * High-energy mechanism of injury
  7. * Concomitant injuries affecting ambulation
  8. * Presence of another injury or medical condition that prevents ambulation
  9. * Presence of implant or sacral morphology that prevents percutaneous sacral fixation
  10. * Enrollment in another research study the precludes co-enrollment
  11. * Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, etc.)
  12. * Incarcerated or pending incarceration

Contacts and Locations

Study Contact

Mai P Nguyen, MD
CONTACT
651-254-3669
mai.p.nguyen@healthpartners.com
Sandy Vang, BA
CONTACT
651-254-6961
sandy.x.vang@healthpartners.com

Principal Investigator

Mai P. Nguyen, MD
PRINCIPAL_INVESTIGATOR
University of Minnesota and HealthPartners

Study Locations (Sites)

Allina, Mercy Hospital
Coon Rapids, Minnesota, 55433
United States
Park Nicollet, Methodist Hospital
Saint Louis Park, Minnesota, 55426
United States
HealthPartners, Regions Hospital
Saint Paul, Minnesota, 55101
United States

Collaborators and Investigators

Sponsor: HealthPartners Institute

  • Mai P. Nguyen, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota and HealthPartners

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-05
Study Completion Date2026-04-01

Study Record Updates

Study Start Date2023-05-05
Study Completion Date2026-04-01

Terms related to this study

Keywords Provided by Researchers

  • Lateral compression
  • Operative
  • Non-operative
  • Fragility fracture
  • Pelvic fracture
  • Percutaneous pelvis screw
  • Osteoporosis

Additional Relevant MeSH Terms

  • Lateral Compression 1 Pelvic Fracture