Accelerated Surgery for Hip Fracture

(HIP ATTACK-2 Trial)

Recruiting at 59 trial locations

Overseen By Valerie Harvey

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Population Health Research Institute

Must not be taking: Anticoagulants, Vitamin K antagonists

Disqualifiers: Emergency surgery, Unstable myocardial infarction, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Immediate to 6 hours post-eligibility

1100 Participants Needed

Trial Summary

What is the purpose of this trial?

The HIP ATTACK-2 trial is a multicentre, international, parallel group randomized controlled trial to determine whether accelerated surgery for hip fracture in patients with acute myocardial injury is superior to standard care in reducing death at 90 days after randomization. The trial will also assess secondary outcomes at 90 days after randomization: inability to independently walk 3 metres, time to first mobilization (first standing and first full weight bear), composite and individual assessment of major complications (e.g., mortality, non-fatal myocardial infarction, acute congestive heart failure, and stroke), delirium, length of stay, pain, and quality of life.

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

The trial does not specify if you need to stop taking your current medications. However, if you are taking certain blood thinners (anticoagulants) without a reversing agent, you may not be eligible to participate.

What data supports the effectiveness of the treatment Accelerated medical clearance and surgery for hip fracture?

Research suggests that accelerated surgery for hip fractures can lead to better outcomes, such as reduced mortality and fewer major complications, compared to standard care. Observational studies and trials like HIP ATTACK indicate that early surgery may improve recovery by minimizing the time patients spend in a state of immobility and stress. ^{1 2 3 4 5}

Is accelerated surgery for hip fracture safe for humans?

Research on accelerated surgery for hip fractures, like the HIP ATTACK trial, suggests it may reduce mortality and major complications compared to standard care, indicating it is generally safe for humans. ^{1 2 5 6 7}

How is accelerated surgical treatment for hip fracture different from standard care?

Accelerated surgical treatment for hip fracture is unique because it involves rapid medical clearance and surgery, aiming to reduce the time patients spend in pain and immobility, which can improve recovery and reduce complications compared to standard care. ^{1 2 3 5 8}

Research Team

Gerard Slobogean, MD

Principal Investigator

University of Maryland, Baltimore

PJ Devereaux, M.D

Principal Investigator

Population Health Research Institute

Robert Feibel, M.D

Principal Investigator

The Ottawa Hospital

Flavia Borges, M.D

Principal Investigator

Population Health Research Institute

Eligibility Criteria

This trial is for individuals aged 45 or older who have a hip fracture from a low-energy event and need surgery, with elevated troponin levels indicating heart muscle injury. It's not for those with certain types of severe heart attacks, on specific anticoagulants without reversal options, refusing consent, previously enrolled in the same trial, needing emergency surgeries for other reasons, or with particular fracture types.

Inclusion Criteria

I have a hip fracture from a low-energy incident needing surgery.

written informed consent

troponin elevation on hospital arrival (at least one troponin level from hip fracture occurrence to randomization above the upper limit of normal)

Exclusion Criteria

patients previously enrolled in HIP ATTACK-2

I need emergency surgery for a condition unrelated to the trial.

I have a fracture around a joint replacement, an open fracture, or fractures on both sides.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo accelerated surgery for hip fracture or standard surgical care

Immediate to 6 hours post-eligibility

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including assessment of major complications and quality of life

90 days

Multiple visits (in-person and virtual)

Rehabilitation

Participants undergo rehabilitation to improve mobility and independence

Within 90 days post-randomization

Treatment Details

Interventions

• Accelerated medical clearance and surgery

Trial Overview The HIP ATTACK-2 trial is testing if getting surgery faster than usual for a hip fracture in patients who also have acute myocardial injury leads to better outcomes like lower death rates at 90 days post-surgery. It will also look at mobility recovery time, complications such as heart failure and stroke, delirium occurrence, pain levels and overall quality of life.

Participant Groups

Group I: Accelerated medical clearance and surgery Experimental Treatment 1 Intervention

Accelerated medical clearance and targeted arrival to the operating room within 6 hours of eligibility criteria met.

Group II: Standard surgical care Active Control 1 Intervention

Hip fracture repair and surgical care according to treating institution guidelines.

Accelerated medical clearance and surgery is already approved in Canada, European Union, United States for the following indications:

Approved in Canada as Accelerated surgical treatment for:

• Hip fracture with acute myocardial injury

Approved in European Union as Accelerated surgical treatment for:

• Hip fracture with acute myocardial injury

Approved in United States as Accelerated surgical treatment for:

• Hip fracture with acute myocardial injury

Who Is Running the Clinical Trial?

Population Health Research Institute

Lead Sponsor

Trials

165

Recruited

717,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

In a pilot trial involving 60 patients with hip fractures, accelerated care (rapid medical clearance and surgery) significantly reduced the time from diagnosis to surgery (6.0 hours vs. 24.2 hours for standard care), suggesting improved efficiency in treatment.

Although the rate of major perioperative complications was lower in the accelerated care group (30%) compared to the standard care group (47%), the difference was not statistically significant, indicating that further research is needed to confirm the safety and efficacy of accelerated care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated care versus standard care among patients with hip fracture: the HIP ATTACK pilot trial. [2022]

The HIP ATTACK trial, involving 2970 patients with hip fractures across 69 hospitals, found that accelerated surgery (within 6 hours of diagnosis) did not significantly reduce mortality or major complications compared to standard care, which had a median surgery time of 24 hours.

Both groups experienced similar rates of mortality (9% for accelerated surgery vs. 10% for standard care) and major complications (22% for both groups), indicating that faster surgery may not provide the expected benefits in these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated surgery versus standard care in hip fracture (HIP ATTACK): an international, randomised, controlled trial. [2023]

The HIP ATTACK trial is a large international study involving 3000 patients aged 45 and older with hip fractures, aiming to determine if accelerated surgery (within 6 hours) improves 90-day mortality and major complications compared to standard care.

The study will assess co-primary outcomes of all-cause mortality and major perioperative complications, potentially providing crucial insights into the benefits of timely surgical intervention for hip fracture patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of the HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) Trial: a protocol for an international randomised controlled trial evaluating early surgery for hip fracture patients. Borges, FK., Bhandari, M., Patel, A., et al.[2020]

The introduction of a comprehensive fast-track treatment program for hip fracture patients significantly reduced in-hospital postoperative complications from 33% to 20%, indicating improved safety and efficacy of care.

Patients in the intervention group experienced a shorter hospital stay (9.7 days) compared to the control group (15.8 days), and community dwellers had a notable reduction in 12-month mortality from 23% to 12%, suggesting enhanced long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comprehensive hip fracture program reduces complication rates and mortality. Pedersen, SJ., Borgbjerg, FM., Schousboe, B., et al.[2022]

In a study of 1820 patients aged 65 and older with hip fractures, there were no significant differences in mortality or readmission rates between those receiving fast-track care and those receiving conventional care within 365 days.

However, patients in the fast-track care group experienced a statistically significant reduction in length of hospital stay and time to surgery, averaging 3.4 days and 6 hours shorter, respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mortality and readmission following hip fracture surgery: a retrospective study comparing conventional and fast-track care. Haugan, K., Johnsen, LG., Basso, T., et al.[2022]

Patients who underwent hip arthroplasty and were discharged early (3-4 days) did not express concerns about their discharge time, indicating that traditional beliefs about longer recovery periods may not hinder acceptance of accelerated discharge.

However, patients did voice worries about managing pain and mobility at home after early discharge, suggesting that enhanced post-operative support may be necessary to ensure their safety and comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early discharge following hip arthroplasty: patients' acceptance masks doubts and concerns. Hunt, GR., Hall, GM., Murthy, BV., et al.[2021]

In a study of 342 patients undergoing Total Knee Arthroplasty (TKA) with an Enhanced Recovery After Surgery (ERAS) Day-surgery protocol, 92.1% were successfully discharged within 24 hours, indicating high efficacy of the protocol for expedited recovery.

Patients who did not meet the 24-hour discharge criteria did not experience increased complications within 30 days or poorer outcomes at 6 months, suggesting that initial failure to discharge early does not negatively impact long-term recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced recovery after surgery (ERAS) protocol reduces need for patient selection for day surgery total knee arthroplasty. Xu, S., Liow, MHL., Eric Liu, X., et al.[2023]

A systematic review of 13 studies involving 177,090 patients found no significant difference in 30-day or inpatient mortality rates for hip fracture surgeries performed during in-hours (IH) versus out-of-hours (OH), suggesting that timing may not impact immediate survival outcomes.

The study also indicated that performing hip fracture surgery on weekends (WE) compared to weekdays (WD) does not increase mortality risk or length of hospital stay, supporting the feasibility of scheduling surgeries outside regular hours to adhere to guidelines for timely intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hip fracture surgery performed out-of-hours-A systematic review and meta-analysis. Kim, RG., An, VVG., Petchell, JF.[2021]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Accelerated care versus standard care among patients with hip fracture: the HIP ATTACK pilot trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Accelerated surgery versus standard care in hip fracture (HIP ATTACK): an international, randomised, controlled trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Rationale and design of the HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) Trial: a protocol for an international randomised controlled trial evaluating early surgery for hip fracture patients. [2020]

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

A comprehensive hip fracture program reduces complication rates and mortality. [2022]

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

Mortality and readmission following hip fracture surgery: a retrospective study comparing conventional and fast-track care. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Early discharge following hip arthroplasty: patients' acceptance masks doubts and concerns. [2021]

7. India pubmed.ncbi.nlm.nih.gov

Enhanced recovery after surgery (ERAS) protocol reduces need for patient selection for day surgery total knee arthroplasty. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Hip fracture surgery performed out-of-hours-A systematic review and meta-analysis. [2021]