RSA-Study of Cemented Hip Prostheses With Five Different Articulations
Primary Purpose
Arthritis
Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
charnley OGEE
Spectron Reflection CoCr
Spectron XLPE CoCr
Spectron Reflection Oxinium
Spectron XLPE CoCR
Sponsored by

About this trial
This is an interventional treatment trial for Arthritis focused on measuring RSA
Eligibility Criteria
Inclusion Criteria:
- arthritis
- dysplasia
Exclusion Criteria:
- obesitas
- charcots
- paget
- malignancy
Sites / Locations
- Haukeland University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
2
3
4
5
1
Arm Description
articulation Spectron EF CoCr/ Reflection All-Poly Eto-sterilized
articulation Spectron Ef CoCr/ Reflection All-Poly XLPE
articulation Spectron EF Oxinium/ Reflection All-Poly Eto-sterilized
articulation Spectron EF Oxinium/ Reflection XLPE
articulation Charnley/ Ogee
Outcomes
Primary Outcome Measures
wear
Secondary Outcome Measures
migration
Full Information
NCT ID
NCT00698672
First Posted
June 16, 2008
Last Updated
February 27, 2017
Sponsor
Haukeland University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00698672
Brief Title
RSA-Study of Cemented Hip Prostheses With Five Different Articulations
Official Title
A Prospective Randomized RSA-Study of Cemented Hip Prostheses With Five Different Articulations
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2004 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare wear and migration of the following hip prostheses:
Charnley monoblock 22.2mm caput and OGEE polyethylene acetabular component
Spectron EF stem with Reflection polyethylene cup and 28 mm CoCr caput
Spectron EF stem with XLPE cup and 28 mm CoCr caput
Spectron EF stem with Reflection polyethylene cup and 28 mm Oxinium caput
Spectron EF stem with XLPE cup and 28 mm Oxinium caput
Detailed Description
Detailed description in:
Wear and migration of highly cross-linked and conventional cemented polyethylene cups with cobalt chrome or Oxinium femoral heads: a randomized radiostereometric study of 150 patients.
Kadar T, Hallan G, Aamodt A, Indrekvam K, Badawy M, Skredderstuen A, Havelin LI, Stokke T, Haugan K, Espehaug B, Furnes O.
J Orthop Res. 2011 Aug;29(8):1222-9. doi: 10.1002/jor.21389
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis
Keywords
RSA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Active Comparator
Arm Description
articulation Spectron EF CoCr/ Reflection All-Poly Eto-sterilized
Arm Title
3
Arm Type
Active Comparator
Arm Description
articulation Spectron Ef CoCr/ Reflection All-Poly XLPE
Arm Title
4
Arm Type
Active Comparator
Arm Description
articulation Spectron EF Oxinium/ Reflection All-Poly Eto-sterilized
Arm Title
5
Arm Type
Active Comparator
Arm Description
articulation Spectron EF Oxinium/ Reflection XLPE
Arm Title
1
Arm Type
Active Comparator
Arm Description
articulation Charnley/ Ogee
Intervention Type
Device
Intervention Name(s)
charnley OGEE
Intervention Description
charnley OGEE
Intervention Type
Device
Intervention Name(s)
Spectron Reflection CoCr
Intervention Description
Spectron Reflection CoCr
Intervention Type
Device
Intervention Name(s)
Spectron XLPE CoCr
Intervention Description
Spectron XLPE CoCr
Intervention Type
Device
Intervention Name(s)
Spectron Reflection Oxinium
Intervention Description
Spectron Reflection Oxinium
Intervention Type
Device
Intervention Name(s)
Spectron XLPE CoCR
Intervention Description
Spectron XLPE CoCR
Primary Outcome Measure Information:
Title
wear
Time Frame
2 years
Secondary Outcome Measure Information:
Title
migration
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
59 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
arthritis
dysplasia
Exclusion Criteria:
obesitas
charcots
paget
malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Kadar, PhD
Organizational Affiliation
Haukeland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
50021
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Not planned
Learn more about this trial
RSA-Study of Cemented Hip Prostheses With Five Different Articulations
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