Internal Fixation vs Nonoperative Care for Pelvic Fractures

(PIVOT-LC1-Pi Trial)

Recruiting at 12 trial locations

Overseen By Pui Yan, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Non-ambulatory, Infection, Pathologic fracture, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 5 days

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates two treatments for a specific type of pelvic fracture: one involves surgery with early internal fixation (using screws or other devices to stabilize the bones), and the other relies on nonoperative care with early rehabilitation (physical therapy to aid movement). Researchers aim to determine which approach is more effective for individuals who have sustained a low-energy injury, such as a fall from standing. The trial targets those aged 60 and older with a specific type of pelvic fracture that remains stable. Participants will be monitored for a year to collect valuable data for future studies. As an unphased trial, this study provides a unique opportunity to contribute to medical knowledge and potentially enhance future treatment options for pelvic fractures.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study on early internal fixation for pelvic fractures showed promising results. It reduced pain and allowed patients to move more quickly. Evidence also indicated a potential reduction in the need for blood transfusions and lessened postoperative pain, suggesting the treatment is generally well-tolerated. However, the methods for holding bones together varied across studies, which may affect results.

While the data is encouraging, this trial remains in its early stages. There is not yet enough information to fully confirm the safety of early internal fixation. More research is needed to better understand its safety and effectiveness in treating pelvic fractures. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatment options for pelvic fractures because they're exploring two different approaches: early internal fixation and nonoperative care with early rehabilitation. Early internal fixation is unique because it involves using specialized devices like cannulated screws or sacroiliac joint fusion devices to stabilize the fracture quickly. This method might provide faster stabilization compared to traditional nonoperative methods, which often rely on physical therapy and rehabilitation alone. On the other hand, nonoperative care with early rehabilitation emphasizes mobilizing patients within 24 hours, aiming for quicker recovery times by integrating early physical therapy. These approaches could lead to improved functional outcomes and faster recovery for patients with pelvic fractures.

What evidence suggests that this trial's treatments could be effective for pelvic fractures?

This trial will compare Early Internal Fixation with Nonoperative Care for pelvic fractures. Research has shown that early fixation of pelvic fractures can be beneficial. Studies indicate it reduces pain, helps patients move sooner, and shortens hospital stays. Specifically, patients with a type of pelvic fracture called LC1 who underwent early surgery experienced less long-term disability than those who did not. This suggests that early surgery could be an effective option for treating these fractures. However, these are initial findings, and further research is ongoing. ^{2 4 6 7 8}

Who Is on the Research Team?

Joseph Patterson, MD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for adults aged 60 or older who have a low-energy type of pelvic fracture (LC1) with less than 10 mm displacement. They must be able to attempt mobilization by rehab providers for at least five days. Specific criteria may exclude some individuals.

Inclusion Criteria

I was injured from a fall while standing.

Injury occurred within 21 days of screening

I am 60 years old or older.

Exclusion Criteria

Terminal illness with expected survival of less than 12 months

Unable to obtain informed consent due to language barriers

I have an infection in or around my hip.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either early internal fixation or nonoperative care with early rehabilitation, which includes at least five days of attempted mobilization

5 days

1 visit (in-person)

Follow-up

Participants are monitored for mortality, ambulation, healthy days at home, and health status at specified intervals

12 months

Visits at 2 weeks, 6 weeks, 4 months, 8 months, and 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Early Internal Fixation
• Nonoperative Care with Early Rehabilitation

Trial Overview The study compares two treatments for elderly patients with specific pelvic fractures: one group will receive early internal fixation surgery, while the other will get nonoperative care paired with early rehabilitation.

How Is the Trial Designed?

Group I: Early Internal Fixation Experimental Treatment 1 Intervention

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).

Group II: Nonoperative Care with Early Rehabilitation Active Control 1 Intervention

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 is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Early Internal Fixation for:

• LC1 fragility fractures of the pelvis

Approved in United States as Early Internal Fixation for:

• LC1 fragility fractures of the pelvis

Approved in Canada as Early Internal Fixation for:

• LC1 fragility fractures of the pelvis

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Orthopaedic Trauma Association

Collaborator

Trials

34

Recruited

5,100+

University of Maryland, Baltimore

Collaborator

Trials

729

Recruited

540,000+

McMaster University

Collaborator

Trials

936

Recruited

2,630,000+

Published Research Related to This Trial

CT-guided percutaneous fixation of unstable pelvic fractures was performed on 20 patients with minimal blood loss and no wound complications, demonstrating a safe alternative to open surgery.

The procedure allowed for early mobilization of patients, with all individuals able to move on the first post-procedural day, highlighting its efficacy in promoting recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CT guided percutaneous fixation of sacroiliac fractures in trauma patients. Blake-Toker, AM., Hawkins, L., Nadalo, L., et al.[2022]

Open reduction and internal fixation is not a one-size-fits-all solution for unstable pelvic fractures, but achieving and maintaining anatomic reduction is crucial for improving long-term outcomes.

The choice of treatment method—whether closed, external, internal, or a combination—should prioritize effective stabilization while minimizing complications, emphasizing the importance of skilled surgical technique and thorough preoperative planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The unstable pelvic fracture. Operative treatment. Kellam, JF., McMurtry, RY., Paley, D., et al.[2022]

High-energy pelvic fractures require immediate management focused on life-saving interventions, particularly addressing major hemorrhage and brain injuries, as these are the leading causes of early mortality.

Definitive fixation of pelvic fractures should be performed by specialized surgeons in well-equipped trauma centers to prevent complications and improve long-term outcomes, including functional recovery and reducing risks of sexual dysfunction and venous thromboembolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractures of the pelvis. Guthrie, HC., Owens, RW., Bircher, MD.[2011]

Immediate stabilization of unstable pelvic fractures using external fixation resulted in fewer complications, such as the need for blood transfusions and reconstructive surgeries, compared to delayed stabilization methods.

The study, which followed 112 patients over 2 years, showed that immediate treatment led to better long-term outcomes, including reduced postoperative pain and fewer late deformities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate stabilization of unstable pelvic fractures versus delayed stabilization. Waikakul, S., Harnroongroj, T., Vanadurongwan, V.[2016]

In a study of 32 patients with unstable pelvic fractures, early external fixation (within 7 days) significantly improved hemodynamic stability and reduced the need for fluid and blood transfusions in patients experiencing traumatic hemorrhagic shock.

Patients treated with early external fixation were able to walk with crutches within 6-8 weeks, and all fractures healed by 12 weeks, demonstrating the efficacy of this intervention in managing unstable pelvic fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External fixation in early treatment of unstable pelvic fractures. Hu, SB., Xu, H., Guo, HB., et al.[2012]

In a study of 236 pelvic ring fracture cases, external fixators were used in 28 patients (11%), primarily for open fractures and complex injuries, demonstrating their continued relevance in managing unstable pelvic injuries.

Out of the 28 patients treated, 20 survived, and 80% of those who survived achieved satisfactory anatomical and functional outcomes, indicating that external fixation remains an effective option for initial and definitive treatment in complex pelvic injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Today's Role of External Fixation in Unstable and Complex Pelvic Fractures. Vécsei, V., Negrin, LL., Hajdu, S.[2018]

In a study of 66 patients with severe pelvic fractures, immediate external fixation was used in 26 patients, showing no difference in mortality (12%) or organ failure rates compared to those treated with bed rest.

The findings suggest that immediate external fixation can help stabilize unstable pelvic fractures, potentially reducing morbidity and soft tissue damage, even though the transfusion requirements were higher in the unstable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate external fixation of unstable pelvic fractures. Gylling, SF., Ward, RE., Holcroft, JW., et al.[2019]

Early fixation of unstable pelvis and acetabular fractures within 24 hours significantly reduces complications (12.4% vs. 19.7%) and pulmonary issues, such as acute respiratory distress syndrome (ARDS), compared to late fixation beyond 24 hours.

Patients who underwent early fixation also experienced a shorter length of stay in the intensive care unit (8.1 days vs. 9.9 days), suggesting that timely surgical intervention can improve recovery outcomes and potentially lower healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early definitive stabilization of unstable pelvis and acetabulum fractures reduces morbidity. Vallier, HA., Cureton, BA., Ekstein, C., et al.[2022]

Early fixation of unstable pelvic fractures significantly reduced hospital stays by 37.8% and long-term disability rates, with only 15.7% of patients in the early fixation group being disabled for at least 6 months compared to 60% in the delayed fixation group.

Patients who underwent early fixation experienced fewer complications, required less blood transfusion (27.2% fewer units), and had a higher survival rate (100% in the early fixation group compared to 83.3% in the delayed group).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved outcome with early fixation of skeletally unstable pelvic fractures. Latenser, BA., Gentilello, LM., Tarver, AA., et al.[2019]

Minimally invasive internal fixation for unstable pelvic fractures in 48 patients resulted in a high bone union rate of 100% and a 91.7% rate of excellent or good functional recovery, indicating its efficacy.

The procedure was associated with minimal trauma, less bleeding, and no significant postoperative complications, highlighting its safety compared to traditional surgical methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of unstable pelvic fractures with minimally invasive internal fixation]. Chen, HW., Zhao, GS., Ye, ZM.[2014]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6530388/

Effectiveness of surgical fixation for lateral compression type ... Fragility fractures of the pelvis (FFP) can result in significant long-term disability, have a significant impact on patients and put a strain ...

2. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06496867

Early Internal Fixation Versus NonOperative Care With ... While the preliminary data supporting the use of early internal fixation for minimally displaced LC1 fragility fractures of the pelvis is promising, the ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0020138325005819

Cost-Effectiveness of Operative Versus Nonoperative ... The goal of this study is to evaluate the cost-effectiveness of operative versus non-operative management for lateral compression type 1 (LC1) ...

4. bmjopen.bmj.com bmjopen.bmj.com/content/9/5/e024737

Effectiveness of surgical fixation for lateral compression ... Results Of 3421 records identified, four retrospective case series met the inclusion criteria. Fixation types were not consistent between studies or within ...

5. link.springer.com link.springer.com/article/10.1007/s11914-024-00891-1

Lateral Compression Fragility Fractures of the Pelvis Early internal fixation appears to decrease pain, facilitate mobilization, accelerate hospital discharge, and minimize morbidity in this ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06496867

Study Details | NCT06496867 | Early Internal Fixation ... While the preliminary data supporting the use of early internal fixation for minimally displaced LC1 fragility fractures of the pelvis is promising, the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11499407/

Lateral Compression Fragility Fractures of the Pelvis Early internal fixation appears to decrease pain, facilitate mobilization, accelerate hospital discharge, and minimize morbidity in this population. Summary.

8. withpower.com withpower.com/trial/phase-fractures-bone-10-2024-dd2eb

Internal Fixation vs Nonoperative Care for Pelvic Fractures Research suggests that immediate stabilization of unstable pelvic fractures with internal fixation can lead to less blood transfusion, less post-operative pain,