Clinical trial NCT05765669: Geriatric Lateral Compression 1 Pelvic Fractures
Official title: Percutaneous Screw Fixation for Operative Treatment Versus Non-Operative Treatment of Geriatric Lateral Compression 1 Pelvic Fractures - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lateral Compression 1 Pelvic Fracture
Keywords: Lateral compression
Operative
Non-operative
Fragility fracture
Pelvic fracture
Percutaneous pelvis screw
Osteoporosis
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: Orthopaedic Trauma Association
name: Allina Health System
First posted: 2023-03-13
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This study is a prospective, randomized control trial (RCT) of 100 patients with fragility pelvic ring fractures. All patients presenting with pelvic ring fractures classified as LC1 confirmed with plain radiographs, CT and/or MRI, resulting from a low energy mechanism or an insufficiency fracture without a precipitating event will undergo a trial of physical therapy with mobilization and multimodal pain management. If the subject has substantial posterior pelvic pain (score ≥ 7 with the Visual Analogue Scale (VAS)) or inability to ambulate after the physical therapy trial for 48 hours, the subject is eligible for enrollment in the RCT. Patients will either be grouped into an operative group, defined as percutaneous screw fixation, or a nonoperative group, defined as treatment with physical therapy and pain management only.

1. Group 1-Operative treatment: Percutaneous screw fixation will be performed for stabilization of the pelvic fracture
2. Group 2-Conservative (non-operative) treatment: Pain management and physical therapy advanced with weight bearing as tolerated.

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

Primary outcomes:
measure: Timed Up and Go (TUG) assessment
timeFrame: Day 2 after treatment
Secondary outcomes:
measure: Sacral Region Pain by Visual Analog Scale
timeFrame: Day 2, 2 weeks, 6 weeks, and 3 months after treatment
measure: Timed Up and Go (TUG) assessment
timeFrame: 2 weeks, 6 weeks, and 3 months after treatment
measure: Discharge Disposition Location
timeFrame: Post discharge from treatment, an average of 5 days from being admitted to the hospital
measure: Longest Distance of Ambulation
timeFrame: Day 2 after treatment
measure: Use of Narcotic Pain Medication
timeFrame: Day 2 after treatment
measure: Hospital Length of Stay
timeFrame: Post discharge from treatment, an average of 5 days from being admitted to the hospital
measure: Rate of Complications
timeFrame: 2 weeks, 6 weeks, and 3 months after treatment
Other outcomes:
Locations:
city: Coon Rapids
country: United States
facility: Allina, Mercy Hospital
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicollet, Methodist Hospital
state: Minnesota
city: Saint Paul
country: United States
facility: HealthPartners, Regions Hospital
state: Minnesota
Study officials:
affiliation: University of Minnesota and HealthPartners
name: Mai P. Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
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