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Sponsors and Collaborators: |
Ullevaal University Hospital Asker & Baerum Hospital |
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Information provided by: | Ullevaal University Hospital |
ClinicalTrials.gov Identifier: | NCT00491673 |
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
Condition | Intervention |
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Femoral Neck Fractures |
Procedure: Uncemented primary bipolar hemiarthroplasty of the hip Procedure: Cemented primary bipolar hemiarthroplasty of the hip |
Study Type: | Interventional |
Study Design: | Active Control, Efficacy Study, Parallel Assignment, Randomized, Single Blind (Outcomes Assessor), Treatment |
Official Title: | A Prospective Randomized Trial of Uncemented Versus Cemented Hemiarthroplasty for Displaced Femoral Neck Fractures |
Enrollment: | 230 |
Study Start Date: | September 2004 |
Study Completion Date: | September 2007 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Uncemented: Active Comparator
Uncemented primary bipolar hemiarthroplasty of the hip
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Procedure: Uncemented primary bipolar hemiarthroplasty of the hip
Uncemented primary bipolar hemiarthroplasty of the hip
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Cemented: Active Comparator
Cemented primary bipolar hemiarthroplasty of the hip
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Procedure: Cemented primary bipolar hemiarthroplasty of the hip
Cemented primary bipolar hemiarthroplasty of the hip
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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 and 1 year:
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.
Ages Eligible for Study: | 70 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Norway | |
Ullevål University Hospital | |
Oslo, Norway, 0407 | |
Norway, Rud | |
Sykehuset Asker And Baerum | |
Oslo, Rud, Norway, 1309 |
Study Chair: | Lars Nordsletten, Prof MD PhD | Ullevål University Hospital, University of Oslo |
Principal Investigator: | Wender Figved, MD | Ullevål University Hospital, University of Oslo |
Study Director: | Lars Nordsletten, Prof MD PhD | Ullevål University Hospital, University of Oslo |
Responsible Party: | Ulleval university hospital ( Lars Nordsletten ) |
Study ID Numbers: | HEMI-SAB-UUS |
Study First Received: | June 25, 2007 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00491673 History of Changes |
Health Authority: | Norway: Norwegian Social Science Data Services; Norway: The National Committees for Research Ethics in Norway |
Arthroplasty Femoral neck Fracture |
Femoral Neck Fractures Hip Fractures Femoral Fractures Fractures, Bone |
Wounds and Injuries Disorders of Environmental Origin Leg Injuries |
Femoral Neck Fractures Hip Fractures Femoral Fractures Fractures, Bone |
Wounds and Injuries Disorders of Environmental Origin Leg Injuries |