A Prospective Randomized Trial of Uncemented Versus Cemented Hemiarthroplasty for Displaced Femoral Neck Fractures
NCT ID: NCT00491673
Last Updated: 2010-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
230 participants
INTERVENTIONAL
2004-09-30
2010-12-31
Brief Summary
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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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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Uncemented
Uncemented primary bipolar hemiarthroplasty of the hip
Uncemented primary bipolar hemiarthroplasty of the hip
Uncemented primary bipolar hemiarthroplasty of the hip
Cemented
Cemented primary bipolar hemiarthroplasty of the hip
Cemented primary bipolar hemiarthroplasty of the hip
Cemented primary bipolar hemiarthroplasty of the hip
Interventions
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Uncemented primary bipolar hemiarthroplasty of the hip
Uncemented primary bipolar hemiarthroplasty of the hip
Cemented primary bipolar hemiarthroplasty of the hip
Cemented primary bipolar hemiarthroplasty of the hip
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥ 70 years old
Exclusion Criteria
* Systemic or local infection
* Short life expectancy/not mobile at all
* Symptomatic coxarthrosis
70 Years
ALL
No
Sponsors
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Asker & Baerum Hospital
OTHER
Ullevaal University Hospital
OTHER
Responsible Party
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Ulleval university hospital
Principal Investigators
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Lars Nordsletten, Prof MD PhD
Role: STUDY_CHAIR
Ullevål University Hospital, University of Oslo
Wender Figved, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Asker and Baerum Hospital
Lars Nordsletten, Prof MD PhD
Role: STUDY_DIRECTOR
Ullevål University Hospital, University of Oslo
Ellen Langslet, MD
Role: PRINCIPAL_INVESTIGATOR
Ullevaal University Hospital
Locations
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Ullevål University Hospital
Oslo, Oslo County, Norway
Sykehuset Asker And Baerum
Oslo, Rud, Norway
Countries
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Related Links
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Pubmed link to publication of 1-year results
Other Identifiers
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HEMI-SAB-UUS
Identifier Type: -
Identifier Source: org_study_id