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

This study is currently recruiting participants.
Verified March 2013 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: March 12, 2013
Last verified: March 2013

November 9, 2007
March 12, 2013
March 2009
March 2017   (final data collection date for primary outcome measure)
Revision surgery [ Time Frame: Measured 2 years after original surgery ] [ Designated as safety issue: No ]
Rates of revision surgery [ Time Frame: 2 years ]
Complete list of historical versions of study NCT00556842 on ClinicalTrials.gov Archive Site
  • Function [ Time Frame: Measured 2 years after original surgery ] [ Designated as safety issue: No ]
  • 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 ]
  • Quality of life [ Time Frame: Measured 2 years after original surgery ] [ Designated as safety issue: No ]
  • Health-related quality of life (Short Form-12 questionnaire (SF-12), Western Ontario McMaster Osteoarthritis Index (WOMAC), and the EuroQol (EQ-5D-health utility)) [ Time Frame: 2 and 10 weeks, 6,9,12,18 and 24 months ]
  • The effect of THA versus HA on mortality, dislocation, infection, femoral fracture, deep venous thrombosis (DVT), and prosthesis loosening. [ Time Frame: 2 and 10 weeks, 6,9,12,18 and 24 months ]
Not Provided
Not Provided
 
Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Revision Surgery and Quality of Life in Adults With Displaced Hip Fractures (The HEALTH Study)
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 Revision Surgery and Quality of Life in Patients With Displaced Femoral Neck Fractures

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hip Fractures
  • Femoral Neck Fractures
  • 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
  • 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
  • Active Comparator: 1
    Participants will undergo total hip arthroplasty.
    Intervention: Device: Total hip arthroplasty
  • Active Comparator: 2
    Participants will undergo hemi-arthroplasty.
    Intervention: Device: Hemi-arthroplasty

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1434
March 2017
March 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Fracture of the femoral neck, as confirmed with either anteroposterior or lateral hip radiographs
  • Displaced fracture that is not, in the judgment of the attending surgeon, optimally managed by internal fixation
  • Operative treatment is planned within 72 hours of the patient being medically cleared for surgery
  • Able to move independently before the fracture
  • Anticipated medical optimization for arthroplasty of the hip
  • 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

Exclusion Criteria:

  • Not suitable for hemi-arthroplasty (i.e., inflammatory arthritis, rheumatoid arthritis, pathologic fractures, or severe osteoarthritis of the hip)
  • Associated 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
  • 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.
  • 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.
Both
50 Years and older
No
Contact: Marilyn Swinton 905-527-4322 ext 44983 simunon@mcmaster.ca
Contact: Taryn Scott 905-527-4322 ext 44696 sprags@mcmaster.ca
United States,   Canada,   Netherlands
 
NCT00556842
UM1 AR063386-01, 1UM1AR063386-01, 1R01 AR055130-01A1
Yes
Boston University
Boston University
  • Canadian Institutes of Health Research (CIHR)
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • Hamilton Health Sciences Corporation
  • ZonMw: The Netherlands Organisation for Health Research and Development
  • Sohpies Minde Foundation for Orthopaedic Research
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
Boston University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP