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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment for pelvic fractures?

Research shows that early internal fixation (stabilizing the bones with metal rods or plates) of unstable pelvic fractures can lead to better outcomes, such as shorter hospital stays, less long-term disability, fewer complications, and improved survival rates compared to delayed fixation. ^{1 2 3 4 5}

Is internal fixation for pelvic fractures generally safe?

Research suggests that immediate stabilization of unstable pelvic fractures with internal fixation can lead to less blood transfusion, less post-operative pain, and fewer late deformities compared to delayed stabilization. Immediate external fixation has also been shown to stabilize severe pelvic fractures, potentially reducing the risk of organ failure and death. ^{2 3 4 6 7}

How does Early Internal Fixation differ from other treatments for pelvic fractures?

Early Internal Fixation involves surgically stabilizing the pelvic bones soon after the fracture is detected, which can reduce the need for blood transfusions, postoperative pain, and late deformities compared to delayed stabilization or nonoperative care. This approach is different from external fixation, which is less invasive but may not provide the same level of stability and long-term outcomes. ^{2 5 8 9 10}

Research Team

Joseph Patterson, MD

Principal Investigator

University of Southern California

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Improved outcome with early fixation of skeletally unstable pelvic fractures. [2019]

2. Thailand pubmed.ncbi.nlm.nih.gov

Immediate stabilization of unstable pelvic fractures versus delayed stabilization. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Immediate external fixation of unstable pelvic fractures. [2019]

4. China pubmed.ncbi.nlm.nih.gov

External fixation in early treatment of unstable pelvic fractures. [2012]

5. Germany pubmed.ncbi.nlm.nih.gov

Today's Role of External Fixation in Unstable and Complex Pelvic Fractures. [2018]

6. China pubmed.ncbi.nlm.nih.gov

[Treatment of unstable pelvic fractures with minimally invasive internal fixation]. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

Early definitive stabilization of unstable pelvis and acetabulum fractures reduces morbidity. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Fractures of the pelvis. [2011]

9. United States pubmed.ncbi.nlm.nih.gov

CT guided percutaneous fixation of sacroiliac fractures in trauma patients. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

The unstable pelvic fracture. Operative treatment. [2022]