Clinical trial NCT01798472: Hip Fractures Treated With Uncemented Arthroplasties
Official title: Cemented Versus Uncemented Arthroplasty in Elderly Patients With Displaced Femoral Neck Fractures: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Femoral Neck Fractures
Keywords: displaced femoral neck fractures
treatment
uncemented arthroplasty
cemented arthroplasty
Lead sponsor: Stockholm South General Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2013-02-25
Enrollment: 140
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Harris Hip Score
timeFrame: 12 month
Secondary outcomes:
measure: Health related quality of life
timeFrame: 12 month
measure: Radiological follow up
timeFrame: 12 month
Other outcomes:
measure: General and surgical complications
timeFrame: from operation until 12 month postoperatively
Locations:
city: Stockholm
country: Sweden
facility: Södersjukhuset (South general hospital), Department of orthopedic surgery
Study officials:
affiliation: Department of orthopedic surgery, South general hospital, Sjukhusbacken 10, 118 83 Stockholm, Sweden
name: Sari Ponzer, M.D. Prof
role: STUDY_DIRECTOR
References: