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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to treat certain hip fractures in older adults by comparing two methods: a surgical approach using small screws (percutaneous transiliac-transsacral screw fixation) and a non-surgical approach involving pain management and physical therapy. The goal is to determine which method improves mobility and reduces pain. Suitable participants are those with a specific type of hip fracture (LC1 pelvic fracture) who experience movement difficulties due to pain from the injury. As an unphased trial, this study allows participants to contribute to important research that could enhance treatment options for future 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 prior data suggests that these treatments are safe for hip fracture management?

Research shows that percutaneous transiliac-transsacral screw fixation can safely treat certain pelvic fractures. Studies have found that this surgery reduces pain and improves movement in patients with weak spots in their sacral bone. It also increases the likelihood of patients returning home sooner after treatment.

The screws used in this surgery are designed to grip more of the bone, enhancing stability and reducing the risk of loosening over time. This design may lead to fewer screw-related issues for patients.

Overall, research supports this surgical method as safe and effective for improving patient recovery. These findings can reassure those considering joining a trial about the procedure's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the treatments for hip fractures being explored in this trial because they offer new approaches to healing and recovery. Unlike the standard surgical options like hip replacement or internal fixation with rods and plates, the percutaneous screw fixation method uses a minimally invasive technique, which may reduce recovery time and lower the risk of complications from surgery. On the non-surgical side, the focus on advanced pain management combined with physical therapy and weight-bearing as tolerated offers a tailored approach to rehabilitation that could lead to quicker mobility and improved quality of life. These innovative strategies are expected to provide more personalized and potentially safer alternatives to traditional treatments.

What evidence suggests that this trial's treatments could be effective for LC1 pelvic fractures?

This trial will compare surgical and non-surgical treatments for hip fractures. Research has shown that percutaneous transiliac-transsacral screw fixation, a procedure participants in the operative arm may receive, can effectively treat sacral fragility fractures, which resemble certain pelvic fractures. Studies have found that this procedure reduces pain and improves mobility. It also increases the likelihood of patients returning home rather than staying in care facilities. This minimally invasive technique uses smaller incisions and typically carries a low risk of complications. Overall, this treatment could significantly enhance recovery for those with similar types of fractures. ^{1 5 6 7 8}

Who Is on the Research Team?

Mai P. Nguyen, MD

Principal Investigator

University of Minnesota and HealthPartners

Are You a Good Fit for This Trial?

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

High-energy mechanism of injury

Enrollment in another research study the precludes co-enrollment

Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, etc.)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29916895/

Percutaneous Transiliac-Transsacral Screw Fixation of ... Conclusions: Percutaneous transiliac-transsacral screw fixation of sacral fragility fractures lessens pain, improves ambulation, and increases the rate of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9202151/

Percutaneous posterior transiliac plate versus iliosacral ... Both percutaneous posterior transiliac plating and IS screw fixation in patients with Tile C-type pelvic bone fractures showed good results.

3. journals.sagepub.com journals.sagepub.com/doi/10.1177/21925682241268141

Transiliac-Transsacral Screw Fixation is Superior to ... To compare the outcomes and complications of transiliac-transsacral screw fixation (TIS) and lumbopelvic fixation (LPS), the 2 most common ...

4. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/percutaneous-pelvic-ring-fixation-in-older-adults

Percutaneous Pelvic Ring Fixation in Older Adults Percutaneous transiliac-transsacral screw fixation of sacral fragility fractures improves pain, ambulation, and rate of disposition to home.

5. nature.com nature.com/articles/s41598-023-39165-8

Retrospective evaluation of percutaneous 3D-navigated ... The presented monoportal PSS technique for fragility fractures of the sacrum is a promising minimally invasive approach with a low complication rate and ...

6. journals.lww.com journals.lww.com/jorthotrauma/fulltext/2019/02000/comment_on__percutaneous_transiliac_transsacral.16.aspx

Comment on: Percutaneous Transiliac–Transsacral Screw... Comment on: Percutaneous Transiliac–Transsacral Screw Fixation of Sacral Fragility Fractures Improves Pain, Ambulation, and Rate of Disposition to Home. Eckardt ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11872379/

Freehand Placement of a Transiliac‐Transsacral Screw for ... Compared to a conventional SI screw, a TITS screw can engage more cortexes, improve fixation stability and decrease screw loosening rate [1, 3, 4, 5]. It's ...

8. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-022-05536-x

Percutaneous posterior transiliac plate versus iliosacral screw ... Both percutaneous posterior transiliac plating and IS screw fixation in patients with Tile C-type pelvic bone fractures showed good results.