A Prospective Randomized Trial of Uncemented Versus Cemented Hemiarthroplasty for Displaced Femoral Neck Fractures
NCT00491673 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230
Last updated 2010-09-24
Summary
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
Conditions
- Femoral Neck Fractures
Interventions
- PROCEDURE
-
Uncemented primary bipolar hemiarthroplasty of the hip
Uncemented primary bipolar hemiarthroplasty of the hip
- PROCEDURE
-
Cemented primary bipolar hemiarthroplasty of the hip
Cemented primary bipolar hemiarthroplasty of the hip
Sponsors & Collaborators
-
Asker & Baerum Hospital
collaborator OTHER -
Ullevaal University Hospital
lead OTHER
Principal Investigators
-
Lars Nordsletten, Prof MD PhD · Ullevål University Hospital, University of Oslo
-
Wender Figved, MD, PhD · Asker and Baerum Hospital
-
Lars Nordsletten, Prof MD PhD · Ullevål University Hospital, University of Oslo
-
Ellen Langslet, MD · Ullevaal University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-09-30
- Primary Completion
- 2010-12-31
- Completion
- 2010-12-31
Countries
- Norway
Study Locations
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