Surgical vs Non-Surgical Treatment for Hip Fracture

Recruiting at 3 trial locations

Overseen By Sandy Vang, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HealthPartners Institute

Disqualifiers: Dementia, Non-ambulatory, Neurologic deficit, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Lateral compression-1 (LC1) pelvic ring fragility fractures cause significant pain and morbidity. These fragility injuries are associated with prolonged immobility and long hospital stays. Currently there is no consensus on operative stabilization of LC1 pelvic fractures, nor are there evidence-based guidelines to aid in management of these injury types. Furthermore, there is variability in operative indications, improvement in pain and mobilization. The purpose of this study is to compare percutaneous screw fixation to non-operative management in symptomatic LC1 fragility fractures in elderly patients.

Will I have to stop taking my current medications?

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 Percutaneous transiliac-transsacral screw fixation for hip fractures?

Research shows that percutaneous transiliac-transsacral screw fixation can improve pain, walking ability, and the likelihood of returning home in patients with sacral fragility fractures. It is also effective for reducing pain in sacral insufficiency fractures that do not respond to non-surgical treatments. ^{1 2 3 4 5}

Is percutaneous transiliac-transsacral screw fixation generally safe for humans?

The procedure is considered safe when performed with careful preoperative planning and precise technical attention, as it involves placing screws through specific areas of the pelvis. It is important to avoid malpositioning to prevent injury to nearby nerves and blood vessels. ^{1 3 4 6 7}

How does percutaneous transiliac-transsacral screw fixation differ from other treatments for hip fractures?

Percutaneous transiliac-transsacral screw fixation is a minimally invasive surgical technique that stabilizes fractures by inserting screws through the ilium (hip bone) and sacrum (base of the spine), which can improve pain and mobility with fewer complications compared to more invasive surgeries. ^{1 2 3 4 5}

Research Team

Mai P. Nguyen, MD

Principal Investigator

University of Minnesota and HealthPartners

Eligibility Criteria

This trial is for people aged 60 or older with a specific type of pelvic fracture (LC1) caused by low energy events like falls. They must have significant pain or difficulty moving even with help, and the injury should be recent, within four weeks. It's not for those with certain implants, unstable fractures, neurological issues, dementia, cancer-related fractures, non-walkers before the injury, other studies' participants or if they can't follow up.

Inclusion Criteria

I have had an injury in the last 4 weeks.

I experience significant pain or can't move well, even with help, after a mobility test.

I am 60 years old or older.

Exclusion Criteria

I have been diagnosed with dementia.

Enrollment in another research study the precludes co-enrollment

Incarcerated or pending incarceration

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either percutaneous screw fixation or non-operative treatment with physical therapy and pain management

6 weeks

Multiple visits for treatment and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments like TUG and pain scale

3 months

Assessments at 2 weeks, 6 weeks, and 3 months

Long-term follow-up

Participants are monitored for long-term outcomes such as complications and mortality

90 days

Treatment Details

Interventions

• Percutaneous transiliac - transsacral screw fixation

Trial Overview The study compares two treatments for elderly patients with LC1 pelvic fractures: one group receives percutaneous transiliac-transsacral screw fixation (a minimally invasive surgical procedure), while the other gets standard care including pain management and physical therapy without surgery.

Participant Groups

Group I: Operative Experimental Treatment 1 Intervention

Percutaneous screw fixation

Group II: Non-operative Experimental Treatment 2 Interventions

Pain management and physical therapy advanced with weight bearing as tolerated.

Percutaneous transiliac - transsacral screw fixation is already approved in United States, European Union for the following indications:

Approved in United States as Percutaneous transiliac-transsacral screw fixation for:

• Geriatric lateral compression-1 (LC1) pelvic ring fragility fractures
• Unstable pelvic fractures
• Posterior pelvic ring injuries

Approved in European Union as Percutaneous transiliac-transsacral screw fixation for:

• Pelvic ring injuries
• Geriatric fragility fractures
• Unstable pelvic fractures

Who Is Running the Clinical Trial?

HealthPartners Institute

Lead Sponsor

Trials

196

Recruited

3,721,000+

Orthopaedic Trauma Association

Collaborator

Trials

34

Recruited

5,100+

Allina Health System

Collaborator

Trials

60

Recruited

1,178,000+

Findings from Research

In a pilot study involving 11 patients with sacral insufficiency fractures that did not improve with nonoperative treatment, the use of transsacral-transiliac screw fixation resulted in significant improvements in pain and disability scores after surgery.

The procedure was found to be safe, with no complications reported, suggesting it could be an effective option for patients who do not respond to conservative treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transsacral-Transiliac Screw Stabilization: Effective for Recalcitrant Pain Due to Sacral Insufficiency Fracture. Sanders, D., Fox, J., Starr, A., et al.[2017]

In a study of 42 patients with complete sacral fractures, the Transiliac Internal Fixator (TIFI) technique resulted in shorter operative and fluoroscopy times compared to the Iliosacral screw (ISS) technique, indicating a potential advantage in efficiency.

Both TIFI and ISS techniques showed comparable functional and radiological outcomes, suggesting that either method is effective for minimally invasive fixation of sacral fractures, with TIFI offering benefits in reduced radiation exposure and ISS resulting in less blood loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally invasive stabilization of posterior pelvic ring injuries through transiliac internal fixator versus Iliosacral screw: A prospective comparative cohort study. El-Hamalawy, AG., Abdel Karim, M., Khaled, SA., et al.[2023]

The transiliac rod and screw fixation (TIF) procedure offers a minimally invasive surgical option for stabilizing unstable pelvic ring fractures, utilizing spinal implants for effective fixation.

In a study of 27 patients with type B or C1 pelvic fractures, 77.8% achieved favorable fracture reduction outcomes, indicating that TIF is a promising treatment method for these injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally Invasive Surgery for Unstable Pelvic Ring Fractures: Transiliac Rod and Screw Fixation. Toda, K., Yagata, Y., Kikuchi, T., et al.[2020]

Patients with sacral fragility fractures who underwent percutaneous transiliac-transsacral screw fixation experienced a significant reduction in pain, with an average improvement of 3.3 points on the visual analog scale compared to nonoperative treatment.

Surgically treated patients demonstrated better ambulation outcomes, with 100% able to walk at discharge versus 72% in the nonoperative group, and a higher average distance ambulated (95 ft vs. 35 ft), while having no surgical complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Transiliac-Transsacral Screw Fixation of Sacral Fragility Fractures Improves Pain, Ambulation, and Rate of Disposition to Home. Walker, JB., Mitchell, SM., Karr, SD., et al.[2019]

In a study of 77 patients with Tile C pelvic fractures, both percutaneous transiliac plate fixation and iliosacral (IS) screw fixation resulted in successful fracture union, indicating both methods are effective for treatment.

While both techniques had similar outcomes, IS screw fixation is recommended as the primary treatment due to its overall effectiveness, with posterior plating suggested for specific cases involving sacral dysmorphism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous posterior transiliac plate versus iliosacral screw fixation for posterior fixation of Tile C-type pelvic fractures: a retrospective comparative study. Kim, CH., Kim, JJ., Kim, JW.[2022]

Percutaneous transsacral, transiliac screw placement is a proven and effective method for managing unstable posterior pelvic ring injuries, emphasizing its established role in surgical practice.

The success of this procedure heavily depends on thorough preoperative planning and careful analysis of imaging to prevent malpositioning, which could harm nearby neurovascular structures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative Planning for Percutaneous Transsacral, Transiliac Screws. Blum, LE., Hake, ME.[2019]

Transiliac-transsacral screws, which are longer screws that go through the entire upper sacrum, provide better stabilization for certain unstable pelvic injuries compared to traditional iliosacral screws, especially in cases of osteoporosis or significant instability.

These screws can be safely inserted using standard intraoperative fluoroscopy, but they require careful planning and technique due to their complex placement through both sacral alar zones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transiliac-transsacral screws for posterior pelvic stabilization. Gardner, MJ., Routt, ML.[2022]

References

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

Transsacral-Transiliac Screw Stabilization: Effective for Recalcitrant Pain Due to Sacral Insufficiency Fracture. [2017]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Minimally invasive stabilization of posterior pelvic ring injuries through transiliac internal fixator versus Iliosacral screw: A prospective comparative cohort study. [2023]

3. Japan pubmed.ncbi.nlm.nih.gov

Minimally Invasive Surgery for Unstable Pelvic Ring Fractures: Transiliac Rod and Screw Fixation. [2020]

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

Percutaneous Transiliac-Transsacral Screw Fixation of Sacral Fragility Fractures Improves Pain, Ambulation, and Rate of Disposition to Home. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Percutaneous posterior transiliac plate versus iliosacral screw fixation for posterior fixation of Tile C-type pelvic fractures: a retrospective comparative study. [2022]

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

Preoperative Planning for Percutaneous Transsacral, Transiliac Screws. [2019]

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

Transiliac-transsacral screws for posterior pelvic stabilization. [2022]