Hip Fractures Treated With Uncemented Arthroplasties
Information source: Stockholm South General Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Femoral Neck Fractures
Intervention: cemented hemiarthroplasty (Procedure); reverse hybrid total hip arthroplasty (Procedure); cemented total hip arthroplasty (Procedure); uncemented hemiarthroplasty (Procedure)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Stockholm South General Hospital Official(s) and/or principal investigator(s): Sari Ponzer, M.D. Prof, Study Director, Affiliation: Department of orthopedic surgery, South general hospital, Sjukhusbacken 10, 118 83 Stockholm, Sweden
Overall contact: Christian Inngul, MD, Phone: 0046708355969, Email: christian.inngul@sodersjukhuset.se
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.
Clinical Details
Official title: Cemented Versus Uncemented Arthroplasty in Elderly Patients With Displaced Femoral Neck Fractures: a Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Harris Hip Score
Secondary outcome: Health related quality of lifeRadiological follow up
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.
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Christian Inngul, MD, Phone: 0046708355969, Email: christian.inngul@sodersjukhuset.se
Södersjukhuset (South general hospital), Department of orthopedic surgery, Stockholm 118 83, Sweden; Recruiting Christian Inngul, M.D., Phone: 0046708355969, Email: christian.inngul@sodersjukhuset.se Christian Inngul, M.D., Principal Investigator Anders Enocson, M.D. Ph.D., Sub-Investigator Richard Blomfeldt, M.D. Ph.D., Sub-Investigator Sari Ponzer, M.D. Prof, Sub-Investigator
Additional Information
Starting date: November 2009
Last updated: January 15, 2015
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