Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Secondary Procedures and Quality of Life in Adults With Displaced Hip Fractures
NCT00556842 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1495
Last updated 2020-07-07
Summary
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.
Conditions
- Hip Fractures
- Femoral Neck Fractures
Interventions
- 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.
- 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.
Sponsors & Collaborators
-
Canadian Institutes of Health Research (CIHR)
collaborator OTHER_GOV -
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
collaborator NIH -
Hamilton Health Sciences Corporation
collaborator OTHER -
ZonMw: The Netherlands Organisation for Health Research and Development
collaborator OTHER -
Sophies Minde Ortopedi
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Mohit Bhandari, MD PhD FRCSC · McMaster University
-
Thomas A. Eihnorn, MD · Boston University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-03-31
- Primary Completion
- 2019-05-30
- Completion
- 2019-05-30
Countries
- United States
- Canada
Study Locations
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