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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
Ullevaal University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Neck Fractures focused on measuring fracture, arthroplasty, wear, osteoporosis, bone

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 22, 2008
Last Updated
June 23, 2009
Sponsor
Ullevaal University Hospital
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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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