Early Internal Fixation Versus NonOperative Care With Early Rehabilitation for LC1 Fragility Fractures of the Pelvis

Not Applicable

Recruiting

• Conditions: Multiple Closed Pelvic Fractures With Disruption of Pelvic Ring; Fragility Fracture; Internal Fixation; Nonoperative Care
• Interventions: Other: Nonoperative Care with Early Rehabilitation; Procedure: Early Internal Fixation

• Registration Number: NCT06496867
• Lead Sponsor: University of Southern California

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.

Study Timeline

• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-07-03
• Study First Posted: 2024-07-11
• Study Start: 2024-11-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-02
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nonoperative Care with Early Rehabilitation	Nonoperative Care with Early Rehabilitation	Nonoperative care with early rehabilitation will consist of nonoperative treatment of the pelvis fracture, including early consultation of the physical therapist, physiotherapist, or local equivalent rehabilitation provider at the time of randomization for a first attempt at mobilization of the patient within 24 hours of randomization
Early Internal Fixation	Early Internal Fixation	Early internal fixation of the LC1 fragility fracture of the pelvis will be defined as percutaneous anterior and/or posterior pelvic internal fixation with cannulated screw(s), medullary implant(s), or sacroiliac joint fusion device(s).

Primary Outcome Measures

Name	Time	Method
Feasibility of participant enrollment	12 months post-randomization	Proportion of patients who provide informed consent
Feasibility of adherence to treatment allocation	12 months post-randomization	Proportion of Adherence to early internal fixation treatment allocation and nonoperative care with early rehabilitation treatment allocation
Refine data collection methods	12 months post-randomization	Proportion of participants with missing data for the primary composite outcome
Assess Protocol Compliance	12 months post-randomization	Proportion of randomization errors

Secondary Outcome Measures

Name	Time	Method
Composite hierarchical outcome of mortality, ambulation, and health days at home.	4 months post-randomization	The secondary outcome (clinical primary outcome) will be a composite endpoint that will hierarchically assess its components in the following order: 1) mortality, 2) ambulation, and 3) healthy days at home. Mortality will consist of all causes of death. Ambulation will be defined as the ability of the patient to ambulate 10 feet or across the room a) without a walking aid or human assistance, b) with a waking aid and without human assistance, c) with human assistance, or d) unable to ambulate. Healthy days at home will be defined by subtracting the following measure components from the number of days in the time frame: mortality days, the total number of days spent in inpatient, observation, skilled nursing facilities (SNF), inpatient psychiatry, inpatient rehabilitation and long-term hospital settings as well as the number of outpatient emergency department and home health visits. The secondary outcomes will be assessed by a per-protocol analysis.

Trial Locations

Locations (13)

Research Institute Vall d'Hebrón - Vall d'Hebron University Hospital; 🇪🇸 Barcelona, Spain

University of Arizona; 🇺🇸 Phoenix, Arizona, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

University of California, Davis; 🇺🇸 Sacramento, California, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Los Angeles General Medical Center; 🇺🇸 Los Angeles, California, United States

University of Maryland, Baltimore - R Adams Cowley Shock Trauma Center; 🇺🇸 Baltimore, Maryland, United States

The Curators of the University of Missouri - Missouri Orthopaedic Institute; 🇺🇸 Columbia, Missouri, United States

University of Washington - Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

Keck Medical Center of USC; 🇺🇸 Los Angeles, California, United States