Ignite Creation Date:
2024-07-17 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496867
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-17
Brief Title:
Early Internal Fixation Versus NonOperative Care With Early Rehabilitation for LC1 Fragility Fractures of the Pelvis
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Multicenter Randomized Controlled Trial Comparing Early Internal Fixation Versus NonOperative Care With Early Rehabilitation for LC1 Fragility Fractures of the Pelvis A Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
PIVOT-LC1-Pi
Brief Summary:
The goal of this randomized pilot study is to assess feasibility of the trial and to collect information to inform the design of a definitive trial Adult patients ages 60 years or older with a low-energy lateral compression type 1 LC1 pelvis fracture with 10 mm initial displacement of the posterior pelvic ring will be eligible to participate in the study Patients will be randomized to one of two treatment groups early internal fixation or nonoperative care with early rehabilitation defined as at least five days of attempted mobilization by rehabilitation providers Participants will be followed for 1 year
Detailed Description:
More than half of fragility fractures of the pelvis in older adults exhibit a lateral compression type 1 fracture pattern LC1 with fractures of the posterior pelvic ring involving the sacrum bone and a corresponding disruption of the anterior pelvic ring Nonoperative treatment has remained the standard of care for older adults with minimally displaced 10 mm LC1 fragility fractures of the pelvis as patients are often able to mobilize within a few days with a walking aid However preliminary data have suggested that early internal fixation may lead to better patient outcomes including improved ambulation shorter hospital stay less use of opioid pain medication greater likelihood of returning home after hospital admission and a lower risk of death compared to nonoperative care While the preliminary data supporting the use of early internal fixation for minimally displaced LC1 fragility fractures of the pelvis is promising the necessary evidence to make this significant practice change remains lacking
The eventual definitive trial has significant potential to change clinical practice and optimize patient outcomes for older adults who experience a minimally displaced LC1 fragility fracture of the pelvis Treating minimally displaced LC1 fragility fractures of the pelvis with early internal fixation instead of nonoperative care would be a paradigm shift in clinical care This pilot study will demonstrate feasibility of the definitive trial and be used to refine aspects of the study protocol as necessary If feasibility is successfully demonstrated the pilot activities will be considered a vanguard phase for the definitive clinical trial
Adult patients ages 60 years or older with a low-energy lateral compression type 1 LC1 pelvis fracture with 10 mm initial displacement of the posterior pelvic ring will be eligible to participate in the study Patients will be randomized to one of two treatment groups early internal fixation or nonoperative care with early rehabilitation defined as at least five days of attempted mobilization by rehabilitation providers Patients will be followed for 1 year with visits occurring at 2 weeks 6 weeks 4 months 8 months and 1 year after fracture At each follow-up mortality ambulation healthy days at home and health status will be collected
The primary objective is to assess feasibility of the trial and to collect information to inform the design of the definitive trial The feasibility outcomes will include participant enrollment adherence to treatment allocation data collection methods and compliance with key aspects of the protocol
The eventual definitive trial has significant potential to change clinical practice and optimize patient outcomes for older adults who experience a minimally displaced LC1 fragility fracture of the pelvis Treating minimally displaced LC1 fragility fractures of the pelvis with early internal fixation instead of nonoperative care would be a paradigm shift in clinical care This pilot study will demonstrate feasibility of the definitive trial and be used to refine aspects of the study protocol as necessary If feasibility is successfully demonstrated the pilot activities will be considered a vanguard phase for the definitive clinical trial
Adult patients ages 60 years or older with a low-energy lateral compression type 1 LC1 pelvis fracture with 10 mm initial displacement of the posterior pelvic ring will be eligible to participate in the study Patients will be randomized to one of two treatment groups early internal fixation or nonoperative care with early rehabilitation defined as at least five days of attempted mobilization by rehabilitation providers Patients will be followed for 1 year with visits occurring at 2 weeks 6 weeks 4 months 8 months and 1 year after fracture At each follow-up mortality ambulation healthy days at home and health status will be collected
The primary objective is to assess feasibility of the trial and to collect information to inform the design of the definitive trial The feasibility outcomes will include participant enrollment adherence to treatment allocation data collection methods and compliance with key aspects of the protocol
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