Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Secondary Procedures and Quality of Life in Adults With Displaced Hip Fractures (The HEALTH Study)
Femoral Neck Fractures
Device: Total hip arthroplasty
|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|
- 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.
- 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.
|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)|
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.
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00556842
|Contact: Paula McKay||905-527-4322 ext firstname.lastname@example.org|
|Contact: Kim Madden||905-527-4322 ext email@example.com|
|United States, Massachusetts|
|Boston University Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02118|
|Contact: Thomas A. Einhorn, MD firstname.lastname@example.org|
|Contact: Heather Silva 617-414-6295 email@example.com|
|Hamilton, Ontario, Canada, L8S4L8|
|Contact: Mohit Bhandari, MD firstname.lastname@example.org|
|Onze Lieve Vrouwe Gasthuis||Completed|
|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|