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RSA-Study of Cemented Hip Prostheses With Five Different Articulations
This study is ongoing, but not recruiting participants.
First Received: June 16, 2008   No Changes Posted
Sponsored by: Haukeland University Hospital
Information provided by: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT00698672
  Purpose

The purpose of this study is to compare wear and migration of the following hip prostheses:

  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

Condition Intervention
Arthritis
 Device: charnley OGEE
Device: Spectron Reflection CoCr
Device: Spectron XLPE CoCr
Device: Spectron Reflection Oxinium
Device: Spectron XLPE CoCR

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study
Official Title: A Prospective Randomized RSA-Study of Cemented Hip Prostheses With Five Different Articulations

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • wear [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • migration [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: November 2004
Estimated Study Completion Date: June 2012
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2: Active Comparator
articulation
Device: Spectron Reflection CoCr
Spectron Reflection CoCr
3: Active Comparator
articulation
Device: Spectron XLPE CoCr
Spectron XLPE CoCr
4: Active Comparator
articulation
Device: Spectron Reflection Oxinium
Spectron Reflection Oxinium
5: Active Comparator
articulation
Device: Spectron XLPE CoCR
Spectron XLPE CoCR
1: Active Comparator
articulation
Device: charnley OGEE
charnley OGEE

  Eligibility

Ages Eligible for Study:   59 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • arthritis
  • dysplasia

Exclusion Criteria:

  • obesitas
  • charcots
  • paget
  • malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698672

Locations
Norway
Haukeland University Hospital
Bergen, Norway, 50021
Sponsors and Collaborators
Haukeland University Hospital
  More Information

No publications provided

Responsible Party: Haukeland University Hospital ( Professor Ove Furnes )
Study ID Numbers: 10642(NSD), 197.03(REK)
Study First Received: June 16, 2008
Last Updated: June 16, 2008
ClinicalTrials.gov Identifier: NCT00698672     History of Changes
Health Authority: Norway: Directorate for Health and Social Affairs;   Norway: The National Committees for Research Ethics in Norway

Keywords provided by Haukeland University Hospital:
RSA

Study placed in the following topic categories:
Musculoskeletal Diseases
Joint Diseases
Arthritis

Additional relevant MeSH terms:
Musculoskeletal Diseases
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on May 07, 2009



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