Radiostereometric Analysis of Acetabular Wear and Periprosthetic Bone Mineral Density Changes in Hemiarthroplasties (HEMI-RSADEXA)
Primary Purpose
Femoral Neck Fractures, Bone Density, Acetabular Wear
Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Cemented primary bipolar hemiarthroplasty of the hip
Uncemented primary bipolar hemiarthroplasty of the hip
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Neck Fractures focused on measuring fracture, arthroplasty, wear, osteoporosis, bone
Eligibility Criteria
Inclusion Criteria:
- Femoral neck fracture
- 65 years or older
- Able to walk independently
Exclusion Criteria:
- Cognitive dysfunction
- Infection
- Fracture caused by malignant disease
Sites / Locations
- Ullevål University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Cemented
Uncemented
Arm Description
Cemented primary bipolar hemiarthroplasty of the hip
Uncemented primary bipolar hemiarthroplasty of the hip
Outcomes
Primary Outcome Measures
Acetabular wear in mm
Loss of bone mineral density (BMD)
Secondary Outcome Measures
Functional outcome including pain (Harris Hip Score)
Activities Of Daily Living (Barthels ADL-Index)
Quality Of Life (EQ-5D)
Full Information
NCT ID
NCT00607516
First Posted
January 22, 2008
Last Updated
June 23, 2009
Sponsor
Ullevaal University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00607516
Brief Title
Radiostereometric Analysis of Acetabular Wear and Periprosthetic Bone Mineral Density Changes in Hemiarthroplasties
Acronym
HEMI-RSADEXA
Official Title
Radiostereometric Analysis of Acetabular Wear and Periprosthetic Bone Mineral Density Changes in Cemented and Uncemented Hemiarthroplasties for Femoral Neck Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Unknown status
Study Start Date
March 2006 (undefined)
Primary Completion Date
January 2009 (Anticipated)
Study Completion Date
January 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Ullevaal University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
Patients are randomised to treatment with cemented or uncemented bipolar hemiarthroplasty. 1mm tantalum markers are inserted in the pelvis during surgery. RSA X-rays and DEXA measurements conducted postoperatively, after 3 and 12 months. Follow-up visits and clinical examination at 3 and 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fractures, Bone Density, Acetabular Wear, Hemiarthroplasty
Keywords
fracture, arthroplasty, wear, osteoporosis, bone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cemented
Arm Type
Active Comparator
Arm Description
Cemented primary bipolar hemiarthroplasty of the hip
Arm Title
Uncemented
Arm Type
Active Comparator
Arm Description
Uncemented primary bipolar hemiarthroplasty of the hip
Intervention Type
Procedure
Intervention Name(s)
Cemented primary bipolar hemiarthroplasty of the hip
Other Intervention Name(s)
Spectron, Smith & Nephew, Memphis, TN
Intervention Description
Cemented primary bipolar hemiarthroplasty of the hip
Intervention Type
Procedure
Intervention Name(s)
Uncemented primary bipolar hemiarthroplasty of the hip
Other Intervention Name(s)
Corail, DePuy/Johnson and Johnson, United Kingdom
Intervention Description
Uncemented primary bipolar hemiarthroplasty of the hip
Primary Outcome Measure Information:
Title
Acetabular wear in mm
Time Frame
1 year
Title
Loss of bone mineral density (BMD)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Functional outcome including pain (Harris Hip Score)
Time Frame
1 year
Title
Activities Of Daily Living (Barthels ADL-Index)
Time Frame
1 year
Title
Quality Of Life (EQ-5D)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Femoral neck fracture
65 years or older
Able to walk independently
Exclusion Criteria:
Cognitive dysfunction
Infection
Fracture caused by malignant disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Nordsletten, Prof MD PhD
Organizational Affiliation
Ullevål University Hospital, University of Oslo
Official's Role
Study Director
Facility Information:
Facility Name
Ullevål University Hospital
City
Oslo
ZIP/Postal Code
0407
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Radiostereometric Analysis of Acetabular Wear and Periprosthetic Bone Mineral Density Changes in Hemiarthroplasties
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