RSA-Study of Cemented Hip Prostheses With Five Different Articulations - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	June 16, 2008
Last Updated Date	June 16, 2008
Start Date ^†	November 2004
Current Primary Outcome Measures ^† (submitted: June 16, 2008)	wear [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^†	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^† (submitted: June 16, 2008)	migration [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^†	Same as current

Descriptive Information
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
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
Study Phase
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study
Condition ^†	Arthritis
Intervention ^†	Device: charnley OGEE Device: Spectron Reflection CoCr Device: Spectron XLPE CoCr Device: Spectron Reflection Oxinium Device: Spectron XLPE CoCR
Study Arms / Comparison Groups	Active Comparator: articulation
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Active, not recruiting
Enrollment ^†	150
Estimated Completion Date	June 2012
Primary Completion Date	June 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^†	Inclusion Criteria: arthritis dysplasia Exclusion Criteria: obesitas charcots paget malignancy
Gender	Both
Ages	59 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	Norway
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00698672
Responsible Party	Professor Ove Furnes, Haukeland University Hospital
Secondary IDs ^††	197.03(REK)
Study Sponsor ^†	Haukeland University Hospital
Collaborators ^††
Investigators ^†
Information Provided By	Haukeland University Hospital
Verification Date	June 2008
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.