Hip fracture Evaluation with ALternatives of Total Hip arthroplasty versus hemi-arthroplasty (HEALTH): a multicentre randomised trial comparing total hip arthroplasty and hemi-arthroplasty on revision surgery and quality of life in patients with displaced femoral neck fractures

McMaster University (Canada)0 个研究点目标入组 2,500 人开始时间: 2009年9月18日最近更新: 2022年6月6日

适应症

试验速览

•1. Adult men or women aged 50 years and older (with no upper age limit)
•2. Fracture of the femoral neck confirmed with either anteroposterior or lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI)
•3. Displaced fracture that is not, in the judgment of the attending surgeon, optimally managed by reduction and internal fixation
•4. Operative treatment within 3 days (i.e. 72 hours) of the patient being medically cleared for surgery
•5. Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker
•6. Anticipated medical optimization for arthroplasty of the hip
•7. Provision of informed consent by patient or proxy
•8. Low energy fracture (defined as a fall from standing height)
•9. No other major trauma
•10. Assurance that surgeons with expertise in both total hip arthroplasty and hemiarthroplasty are available to perform surgery. Note: Surgeons do not need to be experts in both techniques.

•1. Patient not suitable for arthroplasty (e.g. inflammatory arthritis, rheumatoid arthritis, pathologic fracture (secondary to cancer), or severe osteoarthritis of the hip)
•2. Associated major injuries of the lower extremity (i.e., 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)
•3. Retained hardware around the affected hip that will interfere with arthroplasty
•4. Infection around the hip (soft tissue or bone)
•5. Patients with a disorder of bone metabolism other than osteoporosis (i.e., Paget's disease, renal osteodystrophy, osteomalacia)
•6. Patients with a previous history of frank dementia that would interfere with assessment of the primary outcome (i.e., revision surgery at 2 years)
•7. Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e., patients with no fixed address, report a plan to move out of town, or intellectually challenged patients without adequate family support)
•8. Attending surgeon believes the patient should be excluded because enrolled in another ongoing drug or surgical intervention trial
•9. Any other reason

发起方

McMaster University (Canada)