Comparing surgical and conservative treatments for pelvic fractures in elderly patients
Conservative or Operative Therapy in Patients With a Fragility Fracture of the Pelvis: a Prospective, Randomized Controlled Trial
This study is testing whether surgery or non-surgical treatment works better for older people with pelvic fractures caused by minor injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Sex | All |
| Sponsor | Luzerner Kantonsspital Academic / other |
| Locations | 1 site (Lucerne) |
| Trial ID | NCT04744350 on ClinicalTrials.gov |
What this trial studies
This research project focuses on elderly patients with fragility fractures of the pelvis, specifically types IIb and IIc, which can occur from minor trauma. The study aims to determine the best treatment approach by randomizing participants into either surgical intervention using minimal invasive techniques or conservative treatment involving mobilization and physiotherapy. Outcomes will be evaluated through various assessments, including quality of life questionnaires, pain levels, and radiological results, at follow-up intervals of 4 weeks, 4 months, and 1 year post-injury. The goal is to provide evidence-based recommendations for managing these fractures in the elderly population.
Who should consider this trial
Good fit: Ideal candidates are elderly individuals who have sustained a fragility fracture of the pelvis without high-energy trauma and are able to walk 4 meters prior to the fracture.
Not a fit: Patients with high-energy trauma, those with fractures classified as FFP I or III+IV, or individuals deemed non-operable by an anesthesiologist may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for elderly patients with pelvic fractures, potentially reducing pain and complications associated with prolonged immobilization.
How similar studies have performed: Other studies have explored treatment options for fragility fractures, but this specific comparison of surgical versus conservative treatment for FFP IIb and IIc fractures is less commonly addressed, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed Consent as documented by signature * The fracture must be a fragility fracture. This means absence of high energy trauma. * Fragility fracture of the sacrum (FFP II b + c). Involvement of the ventral pelvic ring is not an exclusion criteria. * Able to walk 4 meters before fracture Exclusion Criteria: * Patients who had a high energy trauma. * FFP I or FFP III+IV were operative therapy is recommended * Patient who are not operable according to the anaesthesiologist on call. * Open fractures. * Revision surgeries. * Absent contact information * Living abroad and cannot participate in follow-up visits. * Withdrawal from the study.
Where this trial is running
Lucerne
- Luzerner Kantonsspital — Lucerne, Switzerland (Recruiting)
Study contacts
- Study coordinator: Roemalie Haveman
- Email: Roemaliehaveman@gmail.com
- Phone: 0041 79 618 9774
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.