Clinical trial NCT06496867: Early Internal Fixation Versus NonOperative Care With Early Rehabilitation for LC1 Fragility Fractures of the Pelvis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Closed Pelvic Fractures With Disruption of Pelvic Ring
Fragility Fracture
Internal Fixation
Nonoperative Care
Keywords: Fragility Fracture
Lateral Compression type 1
Pelvis Fracture
Older Adults
Internal Fixation
Nonoperative Care
Physical Therapy
Early
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Orthopaedic Trauma Association
name: McMaster University
name: University of Maryland, Baltimore
First posted: 2024-07-11
Enrollment: 48
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Patient 60 years of age or older.
2. Low energy injury mechanism defined as a fall from standing height.
3. LC1 pelvis fracture (AO/OTA 61B1.1 or 61B2.1) confirmed with antero-posterior, inlet, and outlet pelvis radiographs, computed tomography, or magnetic resonance imaging.
4. Fracture pattern that could be, in the judgment of the attending surgeon, managed with either early internal fixation or nonoperative care with early rehabilitation.
5. Fracture displacement of \<10 mm of the posterior pelvic ring on computed tomography of the pelvis.
6. Injury occurred within 21 days of screening.

Exclusion Criteria:

1. Patient did not ambulate prior to injury.
2. Patient has another condition, injury, or fracture that prevents post-operative weightbearing on any extremity.
3. Retained implants around the pelvis that precludes or limits either study treatment.
4. Infection around the hip (soft tissue or bone).
5. Pathologic fracture with a lytic lesion in the pelvis or sacrum that precludes internal fixation.
6. Patient is too ill, in the judgement of the attending surgeon, for internal fixation.
7. Patient is too ill, in the judgement of the attending surgeon, for nonoperative care.
8. Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
9. Expected injury survival of less than 12 months.
10. Terminal illness with expected survival of less than 12 months.
11. Currently enrolled in a study that does not permit co-enrollment.
12. Prior enrollment in the trial.
13. Unable to obtain informed consent due to language barriers.
14. Unable to obtain informed consent because a legally authorized representative (LAR) was unavailable.
15. Did not provide informed consent (declined participation).
16. Patient or LAR not approached to participate in the trial (missed patient).
17. Other reason to exclude the patient, as approved by the Methods Centre.

Primary outcomes:
measure: Feasibility of participant enrollment
timeFrame: 12 months post-randomization
measure: Feasibility of adherence to treatment allocation
timeFrame: 12 months post-randomization
measure: Refine data collection methods
timeFrame: 12 months post-randomization
measure: Assess Protocol Compliance
timeFrame: 12 months post-randomization
Secondary outcomes:
measure: Composite hierarchical outcome of mortality, ambulation, and health days at home.
timeFrame: 4 months post-randomization
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: University of Arizona
state: Arizona
city: Los Angeles
country: United States
facility: Keck Medical Center of USC
state: California
city: Los Angeles
country: United States
facility: Los Angeles General Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland, Baltimore - R Adams Cowley Shock Trauma Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Columbia
country: United States
facility: The Curators of the University of Missouri - Missouri Orthopaedic Institute
state: Missouri
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Seattle
country: United States
facility: University of Washington - Harborview Medical Center
state: Washington
city: Barcelona
country: Spain
facility: Research Institute Vall d'Hebrón - Vall d'Hebron University Hospital
Study officials:
affiliation: University of Southern California
name: Joseph Patterson, MD
role: PRINCIPAL_INVESTIGATOR
References: