Hip Arthroplasty for Femoral Neck Fracture

(FASTER-HIP Trial)

Not yet recruiting at 1 trial location

Overseen By Pui Yan, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Terminal illness, Incarceration, Language barriers, others

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

Compensation: Varies

Number of Visits: 1

Duration: During hospitalization in the first seven postoperative days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether hip arthroplasty (joint replacement) is more effective than internal fixation (using screws and plates) for treating hip fractures in older adults. Researchers believe arthroplasty may result in better outcomes, such as fewer deaths, more days at home, and improved mobility, compared to internal fixation. Participants should be 60 years or older with a specific type of hip fracture that impairs mobility. As an unphased trial, this study allows participants to contribute to important research that could enhance treatment options for future patients.

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.

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

Research has shown that hip replacement surgery is generally safe, with most patients experiencing good outcomes. One study reported no serious problems, except for a rare case requiring additional surgery. The implants succeeded, with 97.7% lasting at least two years without issues. However, patients receiving hip replacements due to a broken hip bone face a higher risk of medical problems.

Research indicates that internal fixation is also mostly safe. In one study, no problems occurred during surgery. After surgery, only a few patients required a blood transfusion or experienced implant movement. However, about 41% of patients might encounter issues needing correction, suggesting room for improvement in these procedures.

Both treatments carry risks but are generally well-tolerated by patients. ^{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 unique approaches compared to traditional methods. Hip arthroplasty, commonly known as hip replacement, provides a long-term solution by replacing the damaged hip joint entirely, potentially offering quicker recovery and better mobility than just repairing the fracture. On the other hand, internal fixation involves stabilizing the fracture with screws or plates, which is less invasive and preserves the natural joint, allowing for a more conservative approach. These treatments provide distinct options that cater to different patient needs and conditions, enhancing the possibilities for personalized care.

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

This trial will compare hip arthroplasty with internal fixation for treating femoral neck fractures. Research has shown that hip replacement surgery, one of the treatments in this trial, can improve movement and function for patients with hip fractures better than some other surgeries. One study found that total hip replacement has a low risk of hip joint dislocation, between 0% to 5%, making it a safe choice for older adults. Data from a large study over 16 years suggests that modern hip replacement is helpful for certain types of hip fractures.

In contrast, internal fixation, another treatment option in this trial, also yields good results. However, some patients still encounter issues such as implant problems and the need for additional surgery. While both treatments are effective, hip replacement might offer better function and safety for older adults with certain types of hip fractures. ^{6 7 8 9 10}

Who Is on the Research Team?

Joseph T Patterson, MD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for older adults aged 60 and above who have suffered from a type of hip fracture, including femoral neck, intertrochanteric, or subtrochanteric fractures. The study specifically looks at those with minimally displaced fractures.

Inclusion Criteria

Complete fracture of the femoral neck (AO/OTA 31B) confirmed with imaging

I am 60 or older and need surgery for a slightly moved thigh bone fracture.

I have a health condition that affects my ability to move.

Exclusion Criteria

I have a leg injury that stops me from putting weight on it after surgery.

The patient is not clinically suitable for either compared treatment

Expected injury survival of less than 12 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either hip arthroplasty or internal fixation surgery for minimally displaced femoral neck fractures

During hospitalization in the first seven postoperative days

1 visit (in-person, surgical procedure)

Follow-up

Participants are monitored for safety and effectiveness, including ambulation status and days alive and out of hospital

120 days

Regular follow-up visits (in-person and/or virtual)

Extended Follow-up

Participants' health-related quality of life and other secondary outcomes are assessed

365 days

What Are the Treatments Tested in This Trial?

Interventions

• Hip arthroplasty
• Internal fixation

Trial Overview The FASTER-HIP trial is testing whether hip arthroplasty (joint replacement surgery) leads to better outcomes than internal fixation (repairing the bone with metal hardware) in treating certain hip fractures in older adults.

How Is the Trial Designed?

Group I: Internal fixation Active Control 1 Intervention

Group II: Hip arthroplasty Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

McMaster University

Collaborator

Trials

936

Recruited

2,630,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

University of Maryland, Baltimore

Collaborator

Trials

729

Recruited

540,000+

Evellere Group

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11012496/

Evaluation of Outcome after Total Hip Arthroplasty for ... Despite improvements in clinical monitoring and advances in surgical procedures, 1-year mortality remains between 15% and 30%. The aim of this ...

2. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-025-06144-w

Total hip arthroplasty versus hemiarthroplasty for displaced ... Total hip arthroplasty showed better results in terms of function compared to hemiarthroplasty (SMD 0.59, 95% CI 0.11 to 1.08; participants = ...

3. jbjs.org jbjs.org/reader.php?rsuite_id=8be16d38-dc2c-4216-a918-69bb8d4a865b

Hemiarthroplasty Versus Total Hip Arthroplasty for Femoral ... More recent RCTs showed dislocation rates between 0% to 5% following THAs performed for femoral neck fracture15,16, and an updated meta-analysis ...

4. hipandpelvis.or.kr hipandpelvis.or.kr/journal/view.html?doi=10.5371/hp.2020.32.3.148

Clinical Outcomes of Total Hip Arthroplasty for Displaced ... This study demonstrates that THA may be a safe and beneficial option for treating displaced femoral neck fracture in patients ≥80 years of age if they have ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa1906190

Total Hip Arthroplasty or Hemiarthroplasty for Hip Fracture Data on 17,985 femoral neck fractures over a period of 16 years from the Australian Joint Registry suggest that modern hemiarthroplasty and ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40519409/

Safety and Functional Outcomes Following Total Hip ... No serious adverse events were observed apart from the isolated revision case. At two years, implant survivorship was 97.7%, with a single ...

7. cureus.com cureus.com/articles/360420-safety-and-functional-outcomes-following-total-hip-arthroplasty-using-the-latitud-total-hip-replacement-system-in-patients-with-hip-fracture

Safety and Functional Outcomes Following Total Hip ... Post-fracture mortality within one year ranges from 18% to 33%, with a fivefold to eightfold increased risk of death in the first three months ...

8. mdpi.com mdpi.com/2077-0383/13/7/1849

Evaluation of Outcome after Total Hip Arthroplasty for ... The aim of this study is to identify variables that lead to better outcomes in patients treated with total hip arthroplasty (THA) for FNFs.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11347475/

Clinical outcomes of total hip arthroplasty after femoral ... Patients undergoing hip replacement for a femoral neck fracture (FNF) are at substantially higher risk of medical complications including ...

10. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-024-07340-1

Comparison of acute outcomes from elective total hip ... This study has found that THRs performed emergently for fragility FNFs are safe, with equitable outcomes compared to THR performed for elective ...