Radiostereometric Analysis of Acetabular Wear and Periprosthetic Bone Mineral Density Changes in Hemiarthroplasties
HEMI-RSADEXA
2 other identifiers
interventional
22
1 country
1
Brief Summary
Substudy and continuation of HEMI-SAB-UUS (NCT00491673) Study on radiostereometric measurements of acetabular wear in bipolar hemiarthroplasties and measurements of periprosthetic bone mineral density in cemented and uncemented hemiarthroplasties in patients with femoral neck fractures. Null hypothesis: No difference in acetabular wear or in bone mineral density changes between cemented and uncemented hemiarthroplasties
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2006
Typical duration for not_applicable
1 active site
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
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 22, 2008
CompletedFirst Posted
Study publicly available on registry
February 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedJune 24, 2009
February 1, 2007
2.8 years
January 22, 2008
June 23, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Acetabular wear in mm
1 year
Loss of bone mineral density (BMD)
1 year
Secondary Outcomes (3)
Functional outcome including pain (Harris Hip Score)
1 year
Activities Of Daily Living (Barthels ADL-Index)
1 year
Quality Of Life (EQ-5D)
1 year
Study Arms (2)
Cemented
ACTIVE COMPARATORCemented primary bipolar hemiarthroplasty of the hip
Uncemented
ACTIVE COMPARATORUncemented primary bipolar hemiarthroplasty of the hip
Interventions
Cemented primary bipolar hemiarthroplasty of the hip
Uncemented primary bipolar hemiarthroplasty of the hip
Eligibility Criteria
You may qualify if:
- Femoral neck fracture
- years or older
- Able to walk independently
You may not qualify if:
- Cognitive dysfunction
- Infection
- Fracture caused by malignant disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ullevål University Hospital
Oslo, Oslo County, 0407, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lars Nordsletten, Prof MD PhD
Ullevål University Hospital, University of Oslo
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
January 22, 2008
First Posted
February 5, 2008
Study Start
March 1, 2006
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
June 24, 2009
Record last verified: 2007-02