Hip Fractures Treated With Uncemented Arthroplasties (HUA)

Stockholm South General Hospital

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Femoral Neck Fractures

Treatments: Procedure: cemented total hip arthroplasty; Procedure: reverse hybrid total hip arthroplasty; Procedure: cemented hemiarthroplasty; Procedure: uncemented hemiarthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT01798472

2009/1188-31/1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 4 patient groups

uncemented hemiarthroplasty

Experimental group

Description:

Patients aged 80 or older with displaced femoral neck fracture treated with an uncemented hemiarthroplasty

Treatment:

Procedure: uncemented hemiarthroplasty

reverse hybrid total hip arthroplasty

Experimental group

Description:

Patients aged between 65 and 79 years treated with an reverse hybrid arthroplasty.

Treatment:

Procedure: reverse hybrid total hip arthroplasty

cemented hemiarthroplasty

Active Comparator group

Description:

Patients aged 80 or older with displaced femoral neck fracture treated with an cemented hemiarthroplasty

Treatment:

Procedure: cemented hemiarthroplasty

cemented total hip arthroplasty

Active Comparator group

Description:

Patients aged between 65 and 79 years treated with an cemented total hip arthroplasty.

Treatment:

Procedure: cemented total hip arthroplasty