Hip Surgery Options for Femoral Neck Fracture

Recruiting in Palo Alto (17 mi)

+10 other locations

Overseen by Sheila Sprague, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Maryland, Baltimore

Disqualifiers: Non-ambulatory, Hip infection, others

No Placebo Group

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 minimally displaced femoral neck fracture (FNF) treated with surgery will be eligible to participate in the study. Patients will be randomized to one of two treatment groups, hip arthroplasty or internal fixation. Participants will be followed for 1 year.

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.

What data supports the effectiveness of the treatment for femoral neck fractures?

Research shows that both arthroplasty (hip replacement) and internal fixation (using screws or plates to hold bones together) are common treatments for femoral neck fractures. Arthroplasty may have a lower re-operation rate compared to internal fixation, especially when internal fixation fails, suggesting it might be more effective in some cases. ^{1 2 3 4 5}

Is hip surgery for femoral neck fractures generally safe?

Hip surgeries like total hip arthroplasty (THA), hemiarthroplasty (HA), and open reduction internal fixation (ORIF) are generally safe, but they can have complications. Internal fixation may have a higher risk of issues like bone not healing properly or losing blood supply, while arthroplasty is considered for complex cases. ^{3 6 7 8 9}

How does the treatment for femoral neck fracture differ from other treatments?

The treatment options for femoral neck fractures include arthroplasty (hip replacement) and internal fixation (using screws or plates to hold the bone together). Arthroplasty allows for early patient mobilization and has a lower risk of needing revision surgery compared to internal fixation, which is associated with higher risks of complications like bone displacement and non-union. ^{1 2 3 6 10}

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• Arthroplasty (Procedure)
• Internal Fixation (Procedure)

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.

Participant Groups

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, Australia 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

🇦🇺 Approved in Australia as Hip Arthroplasty for:

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Maryland, R Adams Cowley Shock Trauma Center Baltimore, MD

University of Southern California Los Angeles, CA

Yale University New Haven, CT

Inova Fairfax Medical Campus Falls Church, VA

More Trial Locations

Who Is Running the Clinical Trial?

University of Maryland, Baltimore Lead Sponsor

University of Southern California Collaborator

McMaster University Collaborator

Orthopaedic Trauma Association Collaborator

References

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

Internal fixation compared with arthroplasty for displaced fractures of the femoral neck. A meta-analysis. [2022] The optimal choice for the stabilization of displaced femoral neck fractures remains controversial, with alternatives including arthroplasty and internal fixation. Our objective was to determine the effect of arthroplasty (hemiarthroplasty, bipolar arthroplasty, and total hip arthroplasty), compared with that of internal fixation, on rates of mortality, revision, pain, function, operating time, and wound infection in patients with a displaced femoral neck fracture.

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

Should full threaded compression screws be used in adult femoral neck fractures? [2022] Operative treatment consisting of fracture reduction and fixation, or arthroplasty to permit early patient mobilization, continues to be the treatment of choice for most femoral neck fractures. Options for internal fixation have included a variety of implants; however most recent reports and textbooks cite parallel multiple cancellous screws as the surgical technique of choice.

3. United States 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. [2019] Total hip arthroplasty (THA), hemiarthroplasty (HA), and open reduction internal fixation (ORIF) are treatment options for femoral neck fractures. However, the optimal surgical treatment remains unclear. The present study aimed to describe the 30-d postoperative outcomes of THA, HA, and ORIF among patients aged ≥65 y with femoral neck fractures within a national surgical database.

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

The role of internal fixation in the treatment of femoral head necrosis with ipsilateral hip fracture. [2023] Whether internal fixation or hip arthroplasty is the most appropriate initial treatment for patients with ipsilateral hip fracture and osteonecrosis of the femoral head remains unknown. In this study, the prognoses of patients who underwent internal fixation or hip arthroplasty were analyzed and compared to explore the role of internal fixation in treating such patients. We retrospectively reviewed 69 patients diagnosed with osteonecrosis of the femoral head and ipsilateral hip fracture from 1999 to 2018. They were divided into the hip arthroplasty or internal fixation group. The visual analog scale and Harris score were used. The incidence of complications and the conversion to arthroplasty were also investigated to further explore the role of internal fixation. Male patients (male/female: 25/31 vs 20/38, P = .015), younger patients (average age: 46.80 ± 13.14 vs 61.07 ± 15.61, P

5. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of re-operation rates following primary and secondary hemiarthroplasty of the hip. [2016] Primary arthroplasty or internal fixation are the most common ways of treating intracapsular femoral neck fractures, while arthroplasty is the preferred salvage treatment after failed internal fixation. A prospective registration of hip hemiarthroplasties between January 1998 and March 2002 identified 282 procedures for an acute femoral neck fracture and 149 procedures after failed internal fixation with two parallel screws. Chart review was performed after 19-74 months. The groups were comparable in co-morbidities and perioperative conditions. In the primary hemiarthroplasty group 15 of 282 (5%) arthroplasties were re-operated for complications compared to 16 of 149 (11%) in the secondary group (p=0.04). The most common re-operation was soft tissue debridement because of infection. There were more patients with an excision arthroplasty as end result in the secondary hemiarthroplasty group (6 (4%) versus 1 (0.4%); p=0.004). The higher risk of a re-operation after a salvage hemiarthroplasty should be considered when deciding between internal fixation and hemiarthroplasty as treatment for femoral neck fractures.

6. Norway pubmed.ncbi.nlm.nih.gov

Failed internal fixation of femoral neck fractures. [2016] There are two types of surgical treatment for fractures of the femoral neck; internal fixation and arthroplasty. Internal fixation is associated with a higher risk of complications such as secondary displacement, non-union and avascular necrosis. To improve treatment results of internal fixation, we have tried to identify procedure related risk-factors associated with fixation failure.

7. Germany pubmed.ncbi.nlm.nih.gov

Primary prosthetic replacement in per- and intertrochanteric fractures. [2018] Hip arthroplasty is rarely indicated in the treatment of per- and intertrochanteric femur fractures. Although the majority of fractures are amenable to closed- or open reduction and internal fixation (CRIF/ORIF), in some patients the complexity of the fracture or other patient-related factors may cause the orthopaedic surgeon to consider arthroplasty as the treatment of choice. Decision-making is challenging, and a reliable score has not yet been established.

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

Acute total hip arthroplasty versus open reduction internal fixation for posterior wall acetabular fractures in middle-aged patients. [2022] Open reduction internal fixation (ORIF) is the standard of care for displaced acetabular fractures, but the inability to achieve anatomic reduction, involvement of the posterior wall, articular impaction, and femoral head cartilaginous injury are known to lead to poorer outcomes. Acute total hip arthroplasty (THA) is a reasonable treatment option for older patients with an acetabular fracture and risk factors for a poor outcome, but it is only described in case series. The purpose of this study is to compare outcomes of ORIF and acute THA in middle-aged patients with an acetabular fracture from a single center.

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

Which Surgical Approach Provides Maximum Visualization and Access for Open Reduction and Internal Fixation of Femoral Head Fractures? [2022] Femoral head fracture open reduction and internal fixation (ORIF) requires adequate surgical access and visualization. The purpose of this study was to objectively characterize femoral head access associated with commonly used surgical approaches. Our hypothesis was that a surgical hip dislocation (SHD) provides the greatest visualization and access to the femoral head.

10. Switzerland pubmed.ncbi.nlm.nih.gov

Revision rates after surgical treatment for femoral neck fractures: results of 2-year follow-up. [2018] Intracapsular fractures of the femoral neck account for a major share of fractures in the elderly. Open reduction and internal fixation has been shown to have a higher rate of revision surgery than arthroplasty. The aim of this study was to assess and compare the rates of revision surgery performed after internal fixation and primary total hip arthroplasty.