Hip Fractures Treated With Uncemented Arthroplasties

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cemented Versus Uncemented Arthroplasty in Elderly Patients With Displaced Femoral Neck Fractures: a Randomized Controlled Trial

Conditions
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Femoral Neck Fractures

Intervention / Treatment
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* Procedure: cemented hemiarthroplasty
* Procedure: reverse hybrid total hip arthroplasty
* Procedure: cemented total hip arthroplasty
* Procedure: uncemented hemiarthroplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: uncemented hemiarthroplasty<br>Patients aged 80 or older with displaced femoral neck fracture treated with an uncemented hemiarthroplasty | Procedure: uncemented hemiarthroplasty<br>* Patients aged 80 years and older are randomized to uncemented hemiarthroplasty. Fixation of the tapered, proximally hydroxyapatite coated, titanium stem to the host bone by press-fit-technique. The acetabulum is not replaced. The prosthesis articulates with the patients acetabulum with an unipolar, femoral head made of ChromCobalt steel.<br>* Other names: Femoral head: Biomet;|
| Experimental: reverse hybrid total hip arthroplasty<br>Patients aged between 65 and 79 years treated with an reverse hybrid arthroplasty. | Procedure: reverse hybrid total hip arthroplasty<br>* Patients aged 65 to 79 years operated with an uncemented femoral component combined with cemented acetabular cup. The femoral stem is fixed to the host bone by press-fit technique. We use a tapered, proximally hydroxyapatite coated, titanium stem. The acetabular cup is fixed to the host bone with bone cement. We use an all-polyethylene design. Bone cement consists of PolyMetylMetAcrylat.<br>* Other names: Bone cement, Optipac, Biomet;|
| Active Comparator: cemented hemiarthroplasty<br>Patients aged 80 or older with displaced femoral neck fracture treated with an cemented hemiarthroplasty | Procedure: cemented hemiarthroplasty<br>* Patients aged 80 years and older operated with an cemented hemiarthroplasty. Fixation of the wedge-shaped, polished ChromCobalt steel femoral stem to host bone by use of PolyMetylMetAcrylat bone cement. The acetabulum is not replaced. The prosthesis articulates with the patients acetabulum with an unipolar, femoral head made of ChromCobalt steel.<br>* Other names: Bone cement, Optipac, Biomet;|
| Active Comparator: cemented total hip arthroplasty<br>Patients aged between 65 and 79 years treated with an cemented total hip arthroplasty. | Procedure: cemented total hip arthroplasty<br>* Patients aged 65 to 79 years operated with a cemented femoral stem combined with a cemented acetabular cup. Femoral and acetabular component are fixed to the host bone by use of bone cement. The femoral stem is a polished, wedge-shaped design made of ChromCobalt steel. The acetabular cup is fixed to the host bone with bone cement.The acetabular cup an all-polyethylene design. Bone cement consists of PolyMetAcrylat.<br>* Other names: Bone cement, Optipac, Biomet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score | 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 | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life | We use the patient reported instrument EQ-5D. A questionnaire consisting of 5 questions to evaluate health related quality of life. | 12 month | 
| Radiological follow up | Evaluation of radiological outcome on standard hip radiographies with focus on bony ingrowth, signs of loosening and subsidence | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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displaced femoral neck fractures, treatment, uncemented arthroplasty, cemented arthroplasty