RSA-Study of Cemented Hip Prostheses With Five Different Articulations
NCT ID: NCT00698672
Last Updated: 2017-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2004-11-30
2017-06-30
Brief Summary
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1. Charnley monoblock 22.2mm caput and OGEE polyethylene acetabular component
2. Spectron EF stem with Reflection polyethylene cup and 28 mm CoCr caput
3. Spectron EF stem with XLPE cup and 28 mm CoCr caput
4. Spectron EF stem with Reflection polyethylene cup and 28 mm Oxinium caput
5. Spectron EF stem with XLPE cup and 28 mm Oxinium caput
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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2
articulation Spectron EF CoCr/ Reflection All-Poly Eto-sterilized
Spectron Reflection CoCr
Spectron Reflection CoCr
3
articulation Spectron Ef CoCr/ Reflection All-Poly XLPE
Spectron XLPE CoCr
Spectron XLPE CoCr
4
articulation Spectron EF Oxinium/ Reflection All-Poly Eto-sterilized
Spectron Reflection Oxinium
Spectron Reflection Oxinium
5
articulation Spectron EF Oxinium/ Reflection XLPE
Spectron XLPE CoCR
Spectron XLPE CoCR
1
articulation Charnley/ Ogee
charnley OGEE
charnley OGEE
Interventions
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charnley OGEE
charnley OGEE
Spectron Reflection CoCr
Spectron Reflection CoCr
Spectron XLPE CoCr
Spectron XLPE CoCr
Spectron Reflection Oxinium
Spectron Reflection Oxinium
Spectron XLPE CoCR
Spectron XLPE CoCR
Eligibility Criteria
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Inclusion Criteria
* dysplasia
Exclusion Criteria
* charcots
* paget
* malignancy
59 Years
80 Years
ALL
No
Sponsors
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Haukeland University Hospital
OTHER
Responsible Party
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Principal Investigators
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Thomas Kadar, PhD
Role: PRINCIPAL_INVESTIGATOR
Haukeland University Hospital
Locations
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Haukeland University Hospital
Bergen, , Norway
Countries
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References
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Johannessen HG, Hallan G, Kadar T, Lie SA, Lygre SHL, Fenstad AM, Haugan K, Hol PJ, Badawy M, Jonsson B, Indrekvam K, Aamodt A, Furnes O. Early cup migration and wear as predictors for later aseptic loosening: a secondary evaluation of a randomized controlled RSA trial on cemented hip arthroplasties with 18-year follow-up. Acta Orthop. 2025 Aug 15;96:618-624. doi: 10.2340/17453674.2025.44328.
Other Identifiers
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197.03(REK)
Identifier Type: OTHER
Identifier Source: secondary_id
10642(NSD)
Identifier Type: -
Identifier Source: org_study_id
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