A Prospective Randomized Trial of Uncemented Versus Cemented Hemiarthroplasty for Displaced Femoral Neck Fractures
HEMI04
1 other identifier
interventional
230
1 country
2
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2004
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 25, 2007
CompletedFirst Posted
Study publicly available on registry
June 26, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedSeptember 24, 2010
September 1, 2010
6.3 years
June 25, 2007
September 23, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Functional outcome including pain (Harris Hip Score)
5 years
Secondary Outcomes (4)
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
Study Arms (2)
Uncemented
ACTIVE COMPARATORUncemented primary bipolar hemiarthroplasty of the hip
Cemented
ACTIVE COMPARATORCemented primary bipolar hemiarthroplasty of the hip
Interventions
Uncemented primary bipolar hemiarthroplasty of the hip
Cemented primary bipolar hemiarthroplasty of the hip
Eligibility Criteria
You may qualify if:
- Dislocated intracapsular femoral neck fracture
- ≥ 70 years old
You may not qualify if:
- Pathological fracture
- Systemic or local infection
- Short life expectancy/not mobile at all
- Symptomatic coxarthrosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ullevaal University Hospitallead
- Asker & Baerum Hospitalcollaborator
Study Sites (2)
Ullevål University Hospital
Oslo, Oslo County, 0407, Norway
Sykehuset Asker And Baerum
Oslo, Rud, 1309, Norway
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lars Nordsletten, Prof MD PhD
Ullevål University Hospital, University of Oslo
- PRINCIPAL INVESTIGATOR
Wender Figved, MD, PhD
Asker and Baerum Hospital
- STUDY DIRECTOR
Lars Nordsletten, Prof MD PhD
Ullevål University Hospital, University of Oslo
- PRINCIPAL INVESTIGATOR
Ellen Langslet, MD
Ullevaal University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 25, 2007
First Posted
June 26, 2007
Study Start
September 1, 2004
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
September 24, 2010
Record last verified: 2010-09