Percutaneous screw fixation
ProcedureSurgical intervention in the form of percutaneous screw fixation
NCT Number: NCT05765669
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.
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Notify Me60 year–100 year
All sexes
Interventional
Not applicable
Allina, Mercy Hospital, Coon Rapids, Minnesota, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Surgical intervention in the form of percutaneous screw fixation
Non-operative management in the form of pain management and physical therapy advanced with weightbearing as tolerated
Non-operative management in the form of pain management and physical therapy advanced with weightbearing as tolerated
Time frame: Day 2 after treatment
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, 2 weeks, 6 weeks, and 3 months after treatment
Patient reported pain on a scale of 0-10. Minimum score 0 (no pain) to maximum score 10 (worst possible pain)
Time frame: 2 weeks, 6 weeks, and 3 months after treatment
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: Post discharge from treatment, an average of 5 days from being admitted to the hospital
Where a patient went after being discharged from the hospital (home, rehabilitation center, skilled nursing facility)
Time frame: Day 2 after treatment
How far a patient was able to walk
Time frame: Day 2 after treatment
Use of narcotic pain medication, total in milligram equivalents (MME)
Time frame: Post discharge from treatment, an average of 5 days from being admitted to the hospital
Number of days admitted to hospital during treatment
Time frame: 2 weeks, 6 weeks, and 3 months after treatment
Unplanned surgery, new neurological deficit after treatment, surgical site infection, re-admission, decubitus ulcer, pneumonia, deep vein thrombosis, pulmonary embolism, delirium, myocardial infarction, 90 days mortality
HealthPartners Institute
Other
Percutaneous Screw Fixation for Operative Treatment Versus Non-Operative Treatment of Geriatric Lateral Compression 1 Pelvic Fractures - A Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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