Multiple Closed Pelvic Fractures With Disruption of Pelvic RingPIVOT-LC1-PiNCT06496867
Early Internal Fixation Versus NonOperative Care With Early Rehabilitation for LC1 Fragility Fractures of the Pelvis
A study testing Early Internal Fixation and Nonoperative Care with Early Rehabilitation in people with Multiple Closed Pelvic Fractures With Disruption of Pelvic Ring and Fragility Fracture, run by University of Southern California at 13 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Multiple Closed Pelvic Fractures With Disruption of Pelvic Ring, Fragility Fracture, Internal Fixation
- What is being tested?
- Early Internal Fixation and Nonoperative Care with Early Rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 12 Nov 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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).
- Patient or LAR not approached to participate in the trial (missed patient).
- Other reason to exclude the patient, as approved by the Methods Centre.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
University of Maryland, Baltimore - R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 21201
Indiana University
Bloomington, Indiana, 47405
Massachusetts General Hospital
Boston, Massachusetts, 02114
The Curators of the University of Missouri - Missouri Orthopaedic Institute
Columbia, Missouri, 65201
Keck Medical Center of USC
Los Angeles, California, 90033
Los Angeles General Medical Center
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Arizona
Phoenix, Arizona, 85006
University of California, Davis
Sacramento, California, 95817
University of Utah
Salt Lake City, Utah, 84112
University of California San Francisco
San Francisco, California, 94143
University of Washington - Harborview Medical Center
Seattle, Washington, 98104
Spain1 site
Research Institute Vall d'Hebrón - Vall d'Hebron University Hospital
Barcelona, Spain, 08035
About this study
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
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.
Read the 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.
- Conditions
- Multiple Closed Pelvic Fractures With Disruption of Pelvic Ring, Fragility Fracture, Internal Fixation, Nonoperative Care
- Being tested
- Early Internal Fixation, Nonoperative Care with Early Rehabilitation
- Keywords
- Fragility Fracture, Lateral Compression type 1, Pelvis Fracture, Older Adults, Internal Fixation, Nonoperative Care, Physical Therapy, Early
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Internal FixationProcedure or surgery
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.
Nonoperative Care with Early RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 Receives: Other: Nonoperative Care with Early Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of participant enrollment
Proportion of patients who provide informed consent
Measured: 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
Measured: 12 months post-randomization
Refine data collection methods
Proportion of participants with missing data for the primary composite outcome
Measured: 12 months post-randomization
Assess Protocol Compliance
Proportion of randomization errors
Measured: 12 months post-randomization
Secondary outcomes (1)
Composite hierarchical outcome of mortality, ambulation, and health days at home.
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.
Measured: 4 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start12 Nov 2024
- Primary completion21 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: Lower than expected enrollment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Closed Pelvic Fractures With Disruption of Pelvic RingStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopaedic Trauma Association, McMaster University, University of Maryland, Baltimore
- Responsible party
- Principal investigator, Joseph Patterson, University of Southern California
- Investigators
- Joseph Patterson, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496867
- Sponsor's protocol ID
- HS-24-00309
- Acronym
- PIVOT-LC1-Pi
- Status last verified
- Aug 2026
- First submitted
- 17 Jun 2024
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06496867
- Acronym / sponsor ID
- PIVOT-LC1-Pi / HS-24-00309
- 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
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Lower than expected enrollment rate
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Orthopaedic Trauma Association, McMaster University, University of Maryland, Baltimore
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 21 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Internal Fixation | Experimental | Procedure: Early Internal FixationEarly 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). |
| Nonoperative Care with Early Rehabilitation | Active comparator | Other: Nonoperative Care with Early RehabilitationNonoperative 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Internal FixationEarly 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. | Procedure or surgery | Early Internal Fixation |
| Nonoperative Care with Early RehabilitationNonoperative 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. | Other | Nonoperative Care with Early Rehabilitation |
Primary outcome
Feasibility of participant enrollment
Time frame: 12 months post-randomization
Proportion of patients who provide informed consent
Feasibility of adherence to treatment allocation
Time frame: 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
Time frame: 12 months post-randomization
Proportion of participants with missing data for the primary composite outcome
Assess Protocol Compliance
Time frame: 12 months post-randomization
Proportion of randomization errors
1 secondary outcome
Composite hierarchical outcome of mortality, ambulation, and health days at home.
Time frame: 4 months post-randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Patterson, MD principal investigator
University of Southern California
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Internal Fixation and Nonoperative Care with Early Rehabilitation in people with Multiple Closed Pelvic Fractures With Disruption of Pelvic Ring and Fragility Fracture, run by University of Southern California at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of participant enrollment (time frame: 12 months post-randomization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.