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Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Secondary Procedures and Quality of Life in Adults With Displaced Hip Fractures (The HEALTH Study)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Boston University
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Hamilton Health Sciences Corporation
ZonMw: The Netherlands Organisation for Health Research and Development
Sohpies Minde Foundation for Orthopaedic Research
Information provided by (Responsible Party):
Boston University
ClinicalTrials.gov Identifier:
NCT00556842
First received: November 9, 2007
Last updated: November 25, 2014
Last verified: November 2014
  Purpose

Each year, hip fracture, an injury that can impair independence and quality of life, occurs in about 280,000 Americans and 36,000 Canadians. By the year 2040, the annual healthcare costs associated with hip fractures are expected to reach $9.8 billion in the United States and $650 million in Canada. It is important to have in place optimal practice guidelines for the surgical handling of this injury. One type of hip fracture, called a displaced femoral neck fracture, is often treated with a hip replacement surgery. Patients undergoing a hip replacement may receive either a total hip replacement, in which the head of the femur and the hip joint socket are replaced, or a partial hip replacement, in which only the head of the femur is replaced. This study will compare the two different hip replacement procedures to determine which one results in better outcomes after surgery in adults aged 50 and older.


Condition Intervention
Hip Fractures
Femoral Neck Fractures
Device: Total hip arthroplasty
Device: Hemi-arthroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hip Fracture Evaluation With Alternatives of Total Hip Arthroplasty Versus Hemi-Arthroplasty: A Multi-Centre Randomized Trial Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Secondary Procedures and Quality of Life in Patients With Displaced Femoral Neck Fractures

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Revision surgery [ Time Frame: Measured 2 years after original surgery ] [ Designated as safety issue: No ]
    The primary outcome is any unplanned secondary procedure within 2 years of the initial joint replacement surgery.


Secondary Outcome Measures:
  • Function [ Time Frame: Measured 2 years after original surgery ] [ Designated as safety issue: No ]
    Functional outcome and quality of life measured using self-administered and interview-administered questionnaires. Measured using SF-12, WOMAC, EQ-5D and TUG.

  • Complications, including mortality, dislocation, infection, femoral fracture, deep venous thrombosis, and prosthesis loosening [ Time Frame: Measured 2 years after original surgery ] [ Designated as safety issue: Yes ]
    The effect of THA versus HA on mortality.

  • Quality of life [ Time Frame: Measured 2 years after original surgery ] [ Designated as safety issue: No ]
    Hip-related complications including peri-prosthetic fracture, hip instability or dislocation, implant failure (loosening/subsidence and breakage), would healing problems (including superficial/deep infection, wound necrosis), soft tissue problems (e.g. pseudotumor), heterotopic ossification, abductor failure, implant wear and corrosion, osteolysis, neurovascular injury, decreased function, or pain. Measured at 1 and 10 weeks, 6, 9,12, 18, 24 months.


Estimated Enrollment: 1434
Study Start Date: March 2009
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Participants will undergo total hip arthroplasty.
Device: Total hip arthroplasty
Proscribed approaches will include minimally invasive total hip arthroplasty (i.e., two incision approaches) and hinged prostheses or capture cups. Other surgical approach aspects, the use of cemented components, the implant manufacturer, and femoral head size will not be standardized. Surgeons will use the manufacturers' specific implant guidelines for insertion.
Other Name: THA
Active Comparator: 2
Participants will undergo hemi-arthroplasty.
Device: Hemi-arthroplasty
Surgeons will use modern implants for hemi-arthroplasty, excluding non-modular, non-canal filling unipolar implants such as Moore's and Thompson's prostheses. The choice of modular unipolar versus bipolar hemi-arthroplasty will not be standardized. Whether implants are inserted with cement or a press-fit design will also not be standardized. Surgeons will use the manufacturers' specific implant guidelines for insertion.
Other Name: HA

Detailed Description:

One type of hip fracture, called a femoral neck fracture, involves a break in the narrow part of the femur bone where the head of the femur is joined to the main shaft. The break can be either undisplaced, which involves very little separation at the fracture site, or displaced, in which there is substantial separation. For displaced fractures, surgeons usually choose between internal fixation and hip arthroplasty, which is also known as hip replacement.

Patients receiving hip arthroplasty may undergo either a total hip arthroplasty or a hemi-arthroplasty. Which surgical method is best for the patient is unknown. Advocates of total hip replacement claim better improvements in patient function and quality of life. On the other hand, advocates of hemi-arthroplasty, which include most orthepaedic surgeons, claim reduced rates of dislocation and deep vein thrombosis, shorter operating times, less blood loss, and a technically less demanding surgical procedure. This study will compare total hip arthroplasty and hemi-arthroplasty on rates of revision surgery 2 years after patients aged 50 and older sustain femoral neck fractures and undergo surgery. The study will also compare the impact of the two different surgical procedures on function, quality of life, and post-surgical complications. Results from this study may impact current orthopaedic practice.

Participation in this study will last 2 years. Before surgery, participants will complete a baseline assessment that will include x-rays, a medical history review, and a physical examination. Participants will then be randomly assigned to undergo either total hip arthroplasty or hemi-arthroplasty to repair their hip fractures. All surgeons will need to meet certain criteria to partake in the study and will have expertise in whichever surgical procedure they are performing. Surgeons will also follow the manufacturers' implant guidelines during surgery. Specific aspects of both the preoperative and post-operative care, such as weight bearing status, the prevention of thromboembolic disease, and the use of antibiotics and calcium supplementation, will be standardized for all participants. Within 2 days of under going surgery, x-rays will be performed again.

Follow-up assessments will be completed either by phone or in-person at the hospital or clinic. They will occur 1 and 10 weeks after surgery and 6, 9, 12, 18, and 24 months after surgery. All assessments will include questionnaires and interviews on health status, hip function, pain, functional mobility, and revision surgery. Some of the in-person assessments will also include x-rays.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult men or women aged 50 years and old (with no upper age limit)
  • Fracture of the femoral neck, as confirmed with either anteroposterior or lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI)
  • Displaced fracture that is not, in the judgment of the attending surgeon, optimally managed by reduction and internal fixation
  • Operative treatment is planned within 72 hours of the patient being medically cleared for surgery
  • Patient was ambulatory prior to the fracture, though they may have used an aid such as a cane or a walker
  • Anticipated medical optimization for arthroplasty of the hip
  • Provision of informed consent by patient or proxy
  • Low energy fracture (defined as a fall from standing height), with no other trauma
  • Assurance from site that surgeons with expertise in both total hip arthroplasty and hemi-arthroplasty are available to perform surgery (Note: Surgeons do not need to be experts in both techniques)

Exclusion Criteria:

  • Not suitable for hemi-arthroplasty (i.e., inflammatory arthritis, rheumatoid arthritis, pathologic fractures (secondary to cancer), or severe osteoarthritis of the hip)
  • Associated major injuries of the lower extremity (e.g., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture)
  • Retained hardware around the affected hip that will interfere with arthroplasty
  • Infection around the hip (soft tissue or bone)
  • Bone metabolism disorder except osteoporosis (e.g., Paget's disease, renal osteodystrophy, osteomalacia)
  • Patients with a previous history of frank dementia that would interfere with the assessment of primary outcome (e.g., secondary procedures at 2 years).
  • Likely problems, in the judgment of the investigators, with maintaining follow-up (e.g., no fixed address, plans to move out of town in the next year, or intellectually challenged and without adequate family support)
  • Enrolled in another ongoing drug or surgical intervention trial
  • Patients whose fracture occurred as a result of violence.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556842

Contacts
Contact: Paula McKay 905-527-4322 ext 44131 mckayp@mcmaster.ca
Contact: Kim Madden 905-527-4322 ext 44702 maddenk@mcmaster.ca

Locations
United States, Massachusetts
Boston University Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Thomas A. Einhorn, MD       thomas.einhorn@bmc.org   
Contact: Heather Silva    617-414-6295    hdesjard@bu.edu   
Canada, Ontario
McMaster University Recruiting
Hamilton, Ontario, Canada, L8S4L8
Contact: Mohit Bhandari, MD       bhandam@mcmaster.ca   
Netherlands
Onze Lieve Vrouwe Gasthuis Completed
Amsterdam, Netherlands
Sponsors and Collaborators
Boston University
Canadian Institutes of Health Research (CIHR)
Hamilton Health Sciences Corporation
ZonMw: The Netherlands Organisation for Health Research and Development
Sohpies Minde Foundation for Orthopaedic Research
Investigators
Principal Investigator: Mohit Bhandari, MD FRCSC MSc McMaster University
Principal Investigator: Thomas A. Eihnorn, MD Boston University
Principal Investigator: Rudolf Poolman, MD Onze Lieve Vrouwe Gasthuis, Amsterdam
  More Information

Additional Information:
Publications:
Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT00556842     History of Changes
Other Study ID Numbers: UM1 AR063386-01, UM1AR063386, 1R01 AR055130-01A1
Study First Received: November 9, 2007
Last Updated: November 25, 2014
Health Authority: United States: Federal Government

Keywords provided by Boston University:
Hemi-Arthroplasty
Total Hip Arthroplasty

Additional relevant MeSH terms:
Femoral Neck Fractures
Fractures, Bone
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 27, 2014