Comparing surgical and non-surgical treatment for pelvic fractures in older adults

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

This study tests whether surgery or non-surgical treatment works better for older adults with certain types of pelvic fractures to help them feel less pain and move better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 60 Years to 100 Years
• Sex: All
• Sponsor: HealthPartners Institute (other)
• Locations: 3 sites (Coon Rapids, Minnesota and 2 other locations)
• Trial ID: NCT05765669 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of percutaneous screw fixation versus non-operative management for elderly patients with lateral compression 1 pelvic fractures. It is a prospective, randomized control trial involving 100 patients who will first undergo a trial of physical therapy and pain management. If significant pain persists or mobility is not achieved after 48 hours, patients will be randomized into either the surgical or non-surgical treatment group. The goal is to determine which approach leads to better outcomes in terms of pain relief and mobility.

Who should consider this trial

Good fit: Ideal candidates are elderly patients aged 60 and above with lateral compression 1 pelvic ring fractures resulting from low-energy injuries.

Not a fit: Patients with dementia, high-energy injuries, or other conditions that prevent ambulation are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide clearer guidelines for treating a common and painful type of pelvic fracture in older adults.

How similar studies have performed: While there is variability in treatment approaches for pelvic fractures, this specific comparison of surgical versus non-surgical management in this demographic is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Patients \>/= 60 years of age
* Lateral compression 1 pelvic ring fractures confirmed with plain radiographs, CT and/or MRI
* Low energy mechanism of injury or an insufficiency fracture without a precipitating event
* Acute injury within four weeks of presentation
* 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.

Exclusion Criteria:

* Dementia
* Vertically or rotationally unstable pelvic ring injuries
* Pathologic fracture secondary to tumor
* Non-ambulatory prior to injury
* Acute neurologic deficit
* High-energy mechanism of injury
* Concomitant injuries affecting ambulation
* Presence of another injury or medical condition that prevents ambulation
* Presence of implant or sacral morphology that prevents percutaneous sacral fixation
* Enrollment in another research study the precludes co-enrollment
* Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, etc.)
* Incarcerated or pending incarceration

Where this trial is running

Coon Rapids, Minnesota and 2 other locations

• Allina, Mercy Hospital — Coon Rapids, Minnesota, United States (RECRUITING)
• Park Nicollet, Methodist Hospital — Saint Louis Park, Minnesota, United States (RECRUITING)
• HealthPartners, Regions Hospital — Saint Paul, Minnesota, United States (RECRUITING)

Study contacts

• Principal investigator: Mai P. Nguyen, MD — University of Minnesota and HealthPartners
• Study coordinator: Mai P Nguyen, MD

Conditions: Lateral Compression 1 Pelvic Fracture, Lateral compression, Operative, Non-operative, Fragility fracture, Pelvic fracture, Percutaneous pelvis screw, Osteoporosis