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RSA-Study of Cemented Hip Prostheses With Five Different Articulations

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00698672
First Posted: June 17, 2008
Last Update Posted: February 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Haukeland University Hospital
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 ]

Secondary Outcome Measures:
  • migration [ Time Frame: 2 years ]

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

Detailed Description:

Detailed description in:

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   59 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • arthritis
  • dysplasia

Exclusion Criteria:

  • obesitas
  • charcots
  • paget
  • malignancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00698672


Locations
Norway
Haukeland University Hospital
Bergen, Norway, 50021
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Principal Investigator: Thomas Kadar, PhD Haukeland University Hospital
  More Information

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT00698672     History of Changes
Other Study ID Numbers: 10642(NSD)
197.03(REK) ( Other Identifier: Regional Etisk Komite )
First Submitted: June 16, 2008
First Posted: June 17, 2008
Last Update Posted: February 28, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not planned

Keywords provided by Haukeland University Hospital:
RSA