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

NARecruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

November 12, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Multiple Closed Pelvic Fractures With Disruption of Pelvic RingFragility FractureInternal FixationNonoperative Care
Interventions
PROCEDURE

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). 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.

OTHER

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. 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.

Trial Locations (13)

21201

RECRUITING

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

46202

RECRUITING

Indiana University, Indianapolis

65201

RECRUITING

The Curators of the University of Missouri - Missouri Orthopaedic Institute, Columbia

84112

RECRUITING

University of Utah, Salt Lake City

85006

NOT_YET_RECRUITING

University of Arizona, Phoenix

90033

RECRUITING

Keck Medical Center of USC, Los Angeles

RECRUITING

Los Angeles General Medical Center, Los Angeles

90048

RECRUITING

Cedars-Sinai Medical Center, Los Angeles

94143

RECRUITING

University of California San Francisco, San Francisco

95817

RECRUITING

University of California, Davis, Sacramento

98104

RECRUITING

University of Washington - Harborview Medical Center, Seattle

02114

NOT_YET_RECRUITING

Massachusetts General Hospital, Boston

08035

NOT_YET_RECRUITING

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

All Listed Sponsors
collaborator

Orthopaedic Trauma Association

OTHER

collaborator

McMaster University

OTHER

collaborator

University of Maryland, Baltimore

OTHER

lead

University of Southern California

OTHER