Assessment of Polyethylene Wear, Migration and Clinical Outcome in Total Hip Replacement
NCT ID: NCT02196792
Last Updated: 2022-06-21
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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ACTIVE_NOT_RECRUITING
NA
100 participants
INTERVENTIONAL
2009-05-01
2030-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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E-Poly/32 mm
E-Poly polyethylene liner in a titanium cup with a stem with 32 mm cobalt-chromium (CoCr) femoral head.
E-Poly liner
E-Poly liner with a titanium cup
32 mm femoral head
Stem with a 32 mm CoCr femoral head
E-Poly/36 mm
E-Poly polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head.
E-Poly liner
E-Poly liner with a titanium cup
36 mm femoral head
Stem with a 36 mm CoCr femoral head
ArComXL/32 mm
ArComXL polyethylene liner in a titanium cup with a stem with 32 mm CoCr femoral head.
ArComXL liner
ArComXL liner with a titanium cup
32 mm femoral head
Stem with a 32 mm CoCr femoral head
ArComXL/36 mm
ArComXL polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head.
ArComXL liner
ArComXL liner with a titanium cup
36 mm femoral head
Stem with a 36 mm CoCr femoral head
Interventions
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E-Poly liner
E-Poly liner with a titanium cup
ArComXL liner
ArComXL liner with a titanium cup
32 mm femoral head
Stem with a 32 mm CoCr femoral head
36 mm femoral head
Stem with a 36 mm CoCr femoral head
Eligibility Criteria
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Inclusion Criteria
* Eligible for uncemented total hip arthroplasty
* 40 to70 years of age,
* Cup size of 54mm and above
Exclusion Criteria
* Dysplasia (Center-edge angle of Wiberg \< 20°),
* Malignant condition
* Prior radiotherapy
* Physical or psychological condition that renders it impossible for the patient to take part in our usual rehabilitation programme (as stated in the department's standard operation procedure),
* Complications during surgery (requiring screws in shell or femoral cerclage)
40 Years
70 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Odense University Hospital
OTHER
Responsible Party
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Joseph Abdalla Nommesen El-Sahoury
Research assistant
Principal Investigators
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Joseph Abdalla N. El-Sahoury, BSc.med
Role: PRINCIPAL_INVESTIGATOR
OUH Den Ortopædkirurgiske Forskningsenhed
Ming Ding, Professor MD
Role: STUDY_DIRECTOR
Odense University Hospital, University of Southern Denmark
Locations
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Joseph Abdalla Nommesen El-Sahoury
Odense C, Region Syddanmark, Denmark
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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project-ID S-20080151
Identifier Type: -
Identifier Source: org_study_id
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