A Prospective Randomized Trial of Uncemented Versus Cemented Hemiarthroplasty for Displaced Femoral Neck Fractures

Study Overview
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Brief Summary
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There is increasing evidence that primary hemiarthroplasty is the treatment of choice for displaced femoral neck fractures in the elderly No definite conclusions have been made in regards to what kind of arthroplasty is favourable Cemented implants are associated with increased risk of perioperative cardiovascular incidents and increased mortality. Cementless implants are associated with increased postoperative pain and decreased walking ability. This study investigates the differences between one well-documented cemented femoral stem and one well-documented uncemented femoral stem. Previous studies have mostly used uncemented stems with different designs. Null hypothesis: No (less than 10 points) difference in HHS between groups at 1 year and 5 years

Detailed Description
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Inclusion Criteria: Dislocated intracapsular femoral neck fracture in patients ≥ 70 years old Exclusion criteria: Pathological fracture, Systemic or local infection, Short life expectancy/not mobile at all, Symptomatic coxarthrosis. Null hypothesis: No (less than 10 points) difference in HHS between groups at 1 year (SD of HHS is 15 points) Power: 95% Significance: 0.05 60 patients in each group needed. To compensate for high mortality and drop-out: 200 patients, 100 in each group Randomized using www.randomization.org to create sealed opaque envelopes opened at inclusion after signed informed concent. Recorded after surgery: Operating time Arthroplasty components used Need of blood transfusion Blood loss Size of incision Recorded at discharge, 3 months, 1 year and 5 years: X-ray of pelvis and hip Harris Hip Score Barthels ADL-index Quality of life (EQ-5D) Use of analgetics Use of walking aids Publication: International orthopaedic journal.

Official Title
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A Prospective Randomized Trial of Uncemented Versus Cemented Hemiarthroplasty for Displaced Femoral Neck Fractures

Conditions
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Femoral Neck Fractures

Intervention / Treatment
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* Procedure: Uncemented primary bipolar hemiarthroplasty of the hip
* Procedure: Cemented primary bipolar hemiarthroplasty of the hip


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dislocated intracapsular femoral neck fracture ≥ 70 years old Exclusion Criteria: Pathological fracture Systemic or local infection Short life expectancy/not mobile at all Symptomatic coxarthrosis

Ages Eligible for Study
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Minimum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Uncemented<br>Uncemented primary bipolar hemiarthroplasty of the hip | Procedure: Uncemented primary bipolar hemiarthroplasty of the hip<br>* Uncemented primary bipolar hemiarthroplasty of the hip<br>* Other names: Corail, DePuy/Johnson and Johnson, United Kingdom;|
| Active Comparator: Cemented<br>Cemented primary bipolar hemiarthroplasty of the hip | Procedure: Cemented primary bipolar hemiarthroplasty of the hip<br>* Cemented primary bipolar hemiarthroplasty of the hip<br>* Other names: Spectron, Smith & Nephew, Memphis, TN;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome including pain (Harris Hip Score) |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All Cause Mortality |  | 5 years | 
| Activities Of Daily Living (Barthels ADL-Index) |  | 5 years | 
| Quality Of Life (EQ-5D) |  | 5 years | 
| Any treatment related complication |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fracture, Femoral neck, Arthroplasty