Cemented Versus Uncemented Arthroplasty in Elderly Patients With Displaced Femoral Neck Fractures: a Randomized Controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Femoral Neck Fractures
- Sponsor
- Stockholm South General Hospital
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Harris Hip Score
- Last Updated
- 11 years ago
Overview
Brief Summary
The aim of this study is to compare the functional and radiological outcome after displaced, femoral neck fractures treated with either cemented or uncemented arthroplasties.
The primary hypothesis is that the uncemented arthroplasty shows the same functional outcome at 12 month as the cemented arthroplasty.
Detailed Description
Femoral neck fracture is a common cause of suffering and premature mortality among the elderly. Riskfactors for femoral neck fractures are age, gender, osteoporosis and cognitive dysfunction. Mortality and morbidity varies between undisplaced and displaced femoral neck fractures. Different treatment options are available: reduction and internal fixation vs joint replacement (arthroplasty). The treatment of undisplaced femoral neck fractures is uncontroversial and consists of internal fixation with screws. The treatment of displaced, femoral neck fractures with internal fixation shows unacceptable results with complications rates leading to reoperation between 40-60%. Treatment of these fractures with arthroplasties has therefore become the standard treatment in industrial countries. Fixation of the femoral component with bone-cement is standard procedure in Europe today. To avoid negative cardio-pulmonary events in patients with serious comorbidities and in very old and frail patients uncemented femoral components or internal fixation are used. These uncemented stems are mostly older design with poor track records. The use of modern, well-documented stems used in an osteoarthritis population for fracture patients has still to be tested.
Investigators
Christian Inngul
Consultant orthopeadic surgery
Stockholm South General Hospital
Eligibility Criteria
Inclusion Criteria
- •displaced fracture of the femoral neck
- •independent living
- •independent ambulation (with or without walking aids)
Exclusion Criteria
- •pathological fracture
- •severe dementia (defined as ≤3 in short portable mental questionnaire) preoperatively
- •preexisting ipsilateral hip disease
- •neurological disease (e.g. M. Parkinson)
- •psychiatric disease which makes understanding or following instructions impossible
- •history of drug and alcohol abuse
Outcomes
Primary Outcomes
Harris Hip Score
Time Frame: 12 month
Our primary outcome variable is the Harris Hip Score at 12 month follow up. Harris Hip Score is an investigator reported tool evaluating hip function in four dimensions: Pain, function, absence of deformity and range of motion
Secondary Outcomes
- Health related quality of life(12 month)
- Radiological follow up(12 month)