Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Revision Surgery and Quality of Life in Adults With Displaced Hip Fractures (The HEALTH Study)
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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 | Phase |
|---|---|---|
|
Hip Fractures Femoral Neck Fractures |
Device: Total hip arthroplasty Device: Hemi-arthroplasty |
Phase 2 |
| 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 Revision Surgery and Quality of Life in Patients With Displaced Femoral Neck Fractures |
- Revision surgery [ Time Frame: Measured 2 years after original surgery ] [ Designated as safety issue: No ]
- 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 ]
| 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 |
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.
Contacts and Locations| Contact: Marilyn Swinton | 905-527-4322 ext 44983 | simunon@mcmaster.ca |
| Contact: Taryn Scott | 905-527-4322 ext 44696 | sprags@mcmaster.ca |
| United States, Massachusetts | |
| Boston University Medical Center | Not yet 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 | Recruiting |
| Amsterdam, Netherlands | |
| Contact: Rudolph Poolman, MD namloop@gmail.ca | |
| 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, 1UM1AR063386-01, 1R01 AR055130-01A1 |
| Study First Received: | November 9, 2007 |
| Last Updated: | March 12, 2013 |
| 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 |
Wounds and Injuries Leg Injuries Hip Injuries |
ClinicalTrials.gov processed this record on May 23, 2013