RECRUITING

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

Conditions

Multiple Closed Pelvic Fractures with Disruption of Pelvic Ring Fragility Fracture Internal Fixation Nonoperative Care Lateral Compression type 1 Pelvis Fracture Older Adults Physical Therapy Early

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-11-12

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06496867

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Pui Yan, MS

CONTACT

323-442-6984

puiyan@med.usc.edu

Principal Investigator

Joseph Patterson, MD

PRINCIPAL_INVESTIGATOR

University of Southern California

Study Locations (Sites)

Keck Medical Center of USC

Los Angeles, California, 90033

United States

Los Angeles General Medical Center

Los Angeles, California, 90033

United States

Collaborators and Investigators

Sponsor: University of Southern California

Joseph Patterson, MD, PRINCIPAL_INVESTIGATOR, University of Southern California

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-12

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-11-12

Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

Fragility Fracture
Lateral Compression type 1
Pelvis Fracture
Older Adults
Internal Fixation
Nonoperative Care
Physical Therapy
Early

Additional Relevant MeSH Terms

Multiple Closed Pelvic Fractures with Disruption of Pelvic Ring
Fragility Fracture
Internal Fixation
Nonoperative Care