RSA-Study of Cemented Hip Prostheses With Five Different Articulations

February 27, 2017 updated by: Haukeland University Hospital

A Prospective Randomized RSA-Study of Cemented Hip Prostheses With Five Different Articulations

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 50021
        • Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

59 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • arthritis
  • dysplasia

Exclusion Criteria:

  • obesitas
  • charcots
  • paget
  • malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
wear
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
migration
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haukeland University Hospital

Investigators

  • Principal Investigator: Thomas Kadar, PhD, Haukeland University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

June 1, 2007

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

June 16, 2008

First Submitted That Met QC Criteria

June 16, 2008

First Posted (Estimate)

June 17, 2008

Study Record Updates

Last Update Posted (Actual)

February 28, 2017

Last Update Submitted That Met QC Criteria

February 27, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10642(NSD)
  • 197.03(REK) (Other Identifier: Regional Etisk Komite)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not planned

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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