Geriatric Lateral Compression 1 Pelvic Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-100
SponsorHealthPartners Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Dementia
Vertically or rotationally unstable pelvic ring injuries
Pathologic fracture secondary to tumor
Non-ambulatory prior to injury
Trial design
Design model
Parallel
Treatments tested in this trial
Percutaneous screw fixation
Procedure/SurgerySurgical intervention in the form of percutaneous screw fixation
Pain management
Other interventionNon-operative management in the form of pain management and physical therapy advanced with weightbearing as tolerated
Physical therapy
Other interventionNon-operative management in the form of pain management and physical therapy advanced with weightbearing as tolerated
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: OperativeExperimental treatment 1 intervention
Group B: Non-operativeExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Timed Up and Go (TUG) assessment
Valid outcome that measures mobility for elderly patients. The TUG assessment measures the time it takes for a patient, with assistance of physical therapy to get up from a chair, walk 3 meters turn around walk 3 meters back to the chair and sit down.
Time frame
Day 2 after treatmentSecondary outcomes
1
Sacral Region Pain by Visual Analog Scale
Patient reported pain on a scale of 0-10. Minimum score 0 (no pain) to maximum score 10 (worst possible pain)
Time frame
Day 2, 2 weeks, 6 weeks, and 3 months after treatment2
Timed Up and Go (TUG) assessment
Valid outcome that measures mobility for elderly patients. The TUG assessment measures the time it takes for a patient, with assistance of physical therapy to get up from a chair, walk 3 meters turn around walk 3 meters back to the chair and sit down.
Time frame
2 weeks, 6 weeks, and 3 months after treatment3
Discharge Disposition Location
Where a patient went after being discharged from the hospital (home, rehabilitation center, skilled nursing facility)
Time frame
Post discharge from treatment, an average of 5 days from being admitted to the hospital4
Longest Distance of Ambulation
How far a patient was able to walk
Time frame
Day 2 after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
HealthPartners Institute
Lead sponsor
Orthopaedic Trauma Association
Collaborator
Allina Health System
Collaborator
Source ClinicalTrials.gov