RSA-Study of Cemented Hip Prostheses With Five Different Articulations

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT00698672
First received: June 16, 2008
Last updated: September 24, 2013
Last verified: September 2013
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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 2017
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
articulation Spectron EF CoCr/ Reflection All-Poly Eto-sterilized
Device: Spectron Reflection CoCr
Spectron Reflection CoCr
Active Comparator: 3
articulation Spectron Ef CoCr/ Reflection All-Poly XLPE
Device: Spectron XLPE CoCr
Spectron XLPE CoCr
Active Comparator: 4
articulation Spectron EF Oxinium/ Reflection All-Poly Eto-sterilized
Device: Spectron Reflection Oxinium
Spectron Reflection Oxinium
Active Comparator: 5
articulation Spectron EF Oxinium/ Reflection XLPE
Device: Spectron XLPE CoCR
Spectron XLPE CoCR
Active Comparator: 1
articulation Charnley/ Ogee
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Thomas Kadar, M.D. Haukeland University Hospital
  More Information

No publications provided

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT00698672     History of Changes
Other Study ID Numbers: 10642(NSD), 197.03(REK)
Study First Received: June 16, 2008
Last Updated: September 24, 2013
Health Authority: Norway: Directorate of Health
Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Haukeland University Hospital:
RSA

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 26, 2014