Hip Surgery Options for Femoral Neck Fracture

Recruiting at 11 trial locations

Overseen By Heather Phipps, MPS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Non-ambulatory, Hip infection, others

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

Compensation: Varies

Number of Visits: 4

Duration: Surgery and immediate recovery

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two surgery options for treating femoral neck fractures. Participants will be randomly assigned to either hip arthroplasty (a hip replacement procedure) or internal fixation (using screws or plates to stabilize the fracture). The trial aims to assess the feasibility of conducting this study and to gather information for a larger future trial. Individuals who have experienced a low-energy fall, such as tripping or slipping, resulting in a minimally displaced fracture, might be suitable candidates. Researchers will closely monitor participants for a year to evaluate the outcomes of each treatment. As an unphased trial, this study allows participants to contribute to important research that could enhance future treatment options for hip fractures.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

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

A previous study found hip replacements for fragile fractures to be safe, with outcomes similar to planned surgeries. However, the 1-year death rate for hip fracture patients can range from 15% to 30%.

For internal fixation, which uses screws or plates to hold the bone together, results can vary. One study showed this treatment did not succeed as planned for nearly half of the patients over two years, with a 43% failure rate.

Both treatments carry some risks but are generally considered safe for many patients. Discussing options with a doctor is crucial to determine the best course of action. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for femoral neck fractures because they offer tailored approaches based on the patient's needs. Arthroplasty uses modern porous-coated prostheses, which can be customized for younger, active patients with total hip replacements or for older patients with cemented hemiarthroplasties, offering flexibility and potentially better outcomes. Internal fixation stands out by allowing various fixation devices, such as sliding hip screws and multi-screw configurations, providing options for stabilizing the fracture with minimal invasiveness. These advancements could lead to improved recovery and mobility for patients compared to traditional methods.

What evidence suggests that this trial's treatments could be effective for femoral neck fracture?

This trial will compare two treatment options for femoral neck fractures: Arthroplasty and Internal Fixation. Research has shown that hip replacement surgery, or Arthroplasty, can improve hip function for patients with hip fractures. However, the risk of complications, such as hip joint dislocation, is higher in the first year after surgery. Alternatively, Internal Fixation, which uses screws or plates to hold the broken bone together, also results in good hip function and healing, particularly in younger patients. Studies have found that different methods of internal fixation can be effective, with some leading to faster healing and fewer complications. Both treatments offer benefits, and the best choice depends on the patient's specific needs and health condition. ^{3 6 7 8 9}

Who Is on the Research Team?

Gerard Slobogean, MD

Principal Investigator

University of Maryland, Baltimore

Sheila Sprague, PhD

Principal Investigator

McMaster University

Joseph Patterson, MD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This study is for adults aged 60 or older with a specific type of hip fracture (minimally displaced femoral neck fracture) from a low-energy fall. Candidates must be able to undergo surgery and give informed consent themselves or through a proxy. Surgeons performing the operation should be skilled in both arthroplasty and internal fixation techniques.

Inclusion Criteria

You or someone else has agreed to participate in the study after learning about it.

I am 60 years old or older.

I have a confirmed complete break in my hip bone.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either hip arthroplasty or internal fixation surgery

Surgery and immediate recovery

Follow-up

Participants are monitored for safety and effectiveness after treatment, with visits at 6 weeks, 4 months, 8 months, and 1 year

12 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Arthroplasty
• Internal Fixation

Trial Overview

The trial is testing two surgical treatments for hip fractures: hip arthroplasty (replacing part or all of the hip joint) versus internal fixation (stabilizing the bone with hardware). Participants will be randomly assigned to one of these groups and monitored for one year to inform future larger studies.

How Is the Trial Designed?

Group I: Arthroplasty Experimental Treatment 1 Intervention

A modern porous-coated press-fit or cemented hip arthroplasty prosthesis will be used at the treating surgeon's discretion. Press-fit implants that have no ingrowth or ongrowth surface will not be permitted. We recommend surgeons consider a total hip arthroplasty for younger active, independent participants; conversely, a hemiarthroplasty is recommended for more frail, lower-demand participants. Similarly, cemented arthroplasty for older adult participants is also recommended. The surgical approach and the use of post-operative hip precautions will be determined by the treating surgeon.

Group II: Internal Fixation Active Control 1 Intervention

Based on the fracture displacement eligibility criteria, minimal or no reduction is expected during the surgical procedure. However, the treating surgeon will be allowed to perform fracture reduction maneuvers if desired. Fixed angle devices and multiple screws will be permitted. The internal fixation device(s) will be inserted through a small lateral incision. If using multiple cancellous screws, an inverted triangle or similar screw pattern is recommended. Fixed angle devices, such as a sliding hip screw (with or without an anti-rotation screw) or newer multi-screw fixed angle devices will also be permitted. Internal fixation constructs combining cancellous screws and fixed angle devices will be permitted.

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

Approved in European Union as Hip Arthroplasty for:

• Severe osteoarthritis
• Fractures of the hip joint
• Rheumatoid arthritis
• Avascular necrosis

Approved in United States as Hip Replacement for:

• Severe osteoarthritis
• Fractures of the hip joint
• Rheumatoid arthritis
• Avascular necrosis

Approved in Canada as Hip Arthroplasty for:

• Severe osteoarthritis
• Fractures of the hip joint
• Rheumatoid arthritis
• Avascular necrosis

Approved in Japan as Hip Replacement for:

• Severe osteoarthritis
• Fractures of the hip joint
• Rheumatoid arthritis
• Avascular necrosis

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

McMaster University

Collaborator

Trials

936

Recruited

2,630,000+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+

Orthopaedic Trauma Association

Collaborator

Trials

34

Recruited

5,100+

Published Research Related to This Trial

In a study of 282 primary hemiarthroplasties and 149 secondary hemiarthroplasties for femoral neck fractures, the re-operation rate was significantly higher in the secondary group (11%) compared to the primary group (5%), indicating a greater risk of complications after failed internal fixation.

The most common reason for re-operation was infection-related soft tissue debridement, and there was a notable increase in excision arthroplasties in the secondary group, suggesting that salvage procedures may lead to worse outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of re-operation rates following primary and secondary hemiarthroplasty of the hip. Frihagen, F., Madsen, JE., Aksnes, E., et al.[2016]

In a study comparing outcomes of open reduction internal fixation (ORIF) and acute total hip arthroplasty (THA) in middle-aged patients with acetabular fractures, acute THA showed better survival rates of the index procedure and improved functional scores, with an average Oxford Hip Score of 44 compared to 40 for ORIF.

Both treatment options had similar complication rates, but a significant number of patients in the ORIF group (37%) required further surgery or referral for THA, indicating that acute THA may be a more effective long-term solution for these types of fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute total hip arthroplasty versus open reduction internal fixation for posterior wall acetabular fractures in middle-aged patients. MacCormick, LM., Lin, CA., Westberg, JR., et al.[2022]

In a study of 44 patients with femoral neck fractures, partial-threaded cannulated screws resulted in a significantly shorter time to union and fewer complications compared to full-threaded compression screws.

Despite the differences in union time and complication rates, both types of screws provided similar functional outcomes as measured by the Harris Hip Score, indicating that partial-threaded screws may be a safer and equally effective option for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should full threaded compression screws be used in adult femoral neck fractures? Okcu, G., Özkayın, N., Erkan, S., et al.[2022]

In a study of 3423 patients aged 65 and older with femoral neck fractures, there were no significant differences in 30-day mortality rates among those who underwent total hip arthroplasty (THA), hemiarthroplasty (HA), or open reduction internal fixation (ORIF).

Patients who had ORIF or HA were less likely to experience respiratory complications compared to those who underwent THA, suggesting that these surgical options may be safer in terms of respiratory health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open reduction internal fixation versus hemiarthroplasty versus total hip arthroplasty in the elderly: a review of the National Surgical Quality Improvement Program database. Fisher, MA., Matthei, JD., Obirieze, A., et al.[2019]

Arthroplasty for displaced femoral neck fractures significantly reduces the risk of needing revision surgery compared to internal fixation, with a relative risk of 0.23, indicating it is a more stable option in the long term.

However, arthroplasty is associated with higher rates of infection, greater blood loss, and longer operating times, as well as a potential increase in early mortality rates, suggesting that while it may be effective, it comes with increased risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internal fixation compared with arthroplasty for displaced fractures of the femoral neck. A meta-analysis. Bhandari, M., Devereaux, PJ., Swiontkowski, MF., et al.[2022]

In a study of 681 patients with intracapsular femoral neck fractures, those treated with internal fixation had a significantly higher rate of revision surgery (28.9%) compared to those who underwent total hip arthroplasty (7.0%) at the 2-year follow-up.

Patients who received internal fixation were found to be four times more likely to require revision surgery than those who had total hip arthroplasty, suggesting that arthroplasty may be a more effective primary treatment option for these fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revision rates after surgical treatment for femoral neck fractures: results of 2-year follow-up. Kurtinaitis, J., Porvaneckas, N., Kvederas, G., et al.[2018]

The surgical hip dislocation (SHD) approach offers significantly better visualization and access to the femoral head compared to other methods, as shown in a study using 10 fresh-frozen cadaveric pelvis specimens (20 hips).

The Hueter approach was found to provide the least visualization and access, highlighting the importance of choosing the right surgical technique for optimal outcomes in femoral head fracture repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Which Surgical Approach Provides Maximum Visualization and Access for Open Reduction and Internal Fixation of Femoral Head Fractures? Singh, K., Weitlich, JD., Zitsch, BP., et al.[2022]

In a study of 337 patients with femoral neck fractures, achieving a high-quality anatomical reduction (scored six points) significantly reduced the risk of fixation failure, with only 18.3% failure compared to 50% in those with lower scores.

Surgery performed within 48 hours of injury greatly decreased the risk of non-union, with only 8% of patients treated within this timeframe developing non-union, compared to 25% in those treated later.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Failed internal fixation of femoral neck fractures. Hoelsbrekken, SE., Opsahl, JH., Stiris, M., et al.[2016]

Hip arthroplasty is not commonly used for treating per- and intertrochanteric femur fractures, as most cases can be effectively managed with closed- or open reduction and internal fixation (CRIF/ORIF).

A new scoring system, the Hamburg Per- and Intertrochanteric Fracture Score (HPIFS), has been proposed to help surgeons make better treatment decisions by identifying patients who may benefit from arthroplasty based on factors like age, bone quality, and other predictors of poor outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary prosthetic replacement in per- and intertrochanteric fractures. Hoffmann, M., Hartel, M., Rueger, JM., et al.[2018]

In a study of 69 patients with osteonecrosis of the femoral head and ipsilateral hip fracture, those who underwent internal fixation had worse outcomes compared to those who received hip arthroplasty, indicating that hip arthroplasty may be the more effective initial treatment option.

A new scoring system was developed to predict the risk of patients needing conversion from internal fixation to hip arthroplasty, with factors such as age, sex, and fracture type influencing the likelihood of conversion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of internal fixation in the treatment of femoral head necrosis with ipsilateral hip fracture. Zhang, X., Liu, S.[2023]

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