Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05765669
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2023-02-22
Brief Title:
Geriatric Lateral Compression 1 Pelvic Fractures
Sponsor:
HealthPartners Institute
Organization:
HealthPartners Institute
Study Overview
Official Title:
Percutaneous Screw Fixation for Operative Treatment Versus Non-Operative Treatment of Geriatric Lateral Compression 1 Pelvic Fractures - A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None