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

NCT06496867 | Recruiting DMC

• 1 other identifier: HS-24-00309
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 13

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.

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

Outcome Measures

Primary Outcomes (4)

• Feasibility of participant enrollment

  Proportion of patients who provide informed consent

  12 months post-randomization

• Feasibility of adherence to treatment allocation

  Proportion of Adherence to early internal fixation treatment allocation and nonoperative care with early rehabilitation treatment allocation

  12 months post-randomization

• Refine data collection methods

  Proportion of participants with missing data for the primary composite outcome

  12 months post-randomization

• Assess Protocol Compliance

  Proportion of randomization errors

  12 months post-randomization

Secondary Outcomes (1)

• Composite hierarchical outcome of mortality, ambulation, and health days at home.

  4 months post-randomization

Study Arms (2)

Early Internal Fixation

EXPERIMENTAL

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).

Procedure: Early Internal Fixation

Nonoperative Care with Early Rehabilitation

ACTIVE COMPARATOR

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

Other: Nonoperative Care with Early Rehabilitation

Interventions

Early Internal Fixation PROCEDURE

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). The implant number, design, diameter, thread type (fully-threaded or partially-threaded), sacral segment (S1, S2, S3, or any combination there of), length, trajectory including sacroiliac or transsacral-transiliac, application with or without a washer, and ingrowth or ongrowth surface designs will be at the discretion of the treating surgeon.

Early Internal Fixation

Nonoperative Care with Early Rehabilitation OTHER

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. Patients who are unable to ambulate with assistance after five or more days of attempted mobilization by rehabilitation providers may be considered for delayed internal fixation treatment at the discretion of the patient and the treating surgeon. Delayed internal fixation after five or more days of attempted mobilization by rehabilitation providers will not be considered a treatment crossover event.

Nonoperative Care with Early Rehabilitation

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient 60 years of age or older.
• Low energy injury mechanism defined as a fall from standing height.
• 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.
• Fracture pattern that could be, in the judgment of the attending surgeon, managed with either early internal fixation or nonoperative care with early rehabilitation.
• Fracture displacement of \<10 mm of the posterior pelvic ring on computed tomography of the pelvis.
• Injury occurred within 21 days of screening.

You may not qualify if:

• Patient did not ambulate prior to injury.
• Patient has another condition, injury, or fracture that prevents post-operative weightbearing on any extremity.
• Retained implants around the pelvis that precludes or limits either study treatment.
• Infection around the hip (soft tissue or bone).
• Pathologic fracture with a lytic lesion in the pelvis or sacrum that precludes internal fixation.
• Patient is too ill, in the judgement of the attending surgeon, for internal fixation.
• Patient is too ill, in the judgement of the attending surgeon, for nonoperative care.
• Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
• Expected injury survival of less than 12 months.
• Terminal illness with expected survival of less than 12 months.
• Currently enrolled in a study that does not permit co-enrollment.
• Prior enrollment in the trial.
• Unable to obtain informed consent due to language barriers.
• Unable to obtain informed consent because a legally authorized representative (LAR) was unavailable.
• Did not provide informed consent (declined participation).

Sponsors & Collaborators

• University of Southern California: lead
• Orthopaedic Trauma Association: collaborator
• McMaster University: collaborator
• University of Maryland, Baltimore: collaborator

Study Sites (13)

University of Arizona

Phoenix, Arizona, 85006, United States

NOT YET RECRUITING

Keck Medical Center of USC

Los Angeles, California, 90033, United States

RECRUITING

Los Angeles General Medical Center

Los Angeles, California, 90033, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

University of California, Davis

Sacramento, California, 95817, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Maryland, Baltimore - R Adams Cowley Shock Trauma Center

Baltimore, Maryland, 21201, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

NOT YET RECRUITING

The Curators of the University of Missouri - Missouri Orthopaedic Institute

Columbia, Missouri, 65201, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

University of Washington - Harborview Medical Center

Seattle, Washington, 98104, United States

RECRUITING

Research Institute Vall d'Hebrón - Vall d'Hebron University Hospital

Barcelona, Spain, 08035, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Joseph Patterson, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pui Yan, MS

CONTACT

323-442-6984; puiyan@med.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: July 11, 2024
• Study Start: November 12, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); US (12)