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Status unknownNCT00698672Updated Feb 28, 2017

RSA-Study of Cemented Hip Prostheses With Five Different Articulations

An interventional study of charnley OGEE and Spectron Reflection CoCr in Arthritis, sponsored by Haukeland University Hospital. Status unknown at 1 site in Norway. Open to participants aged 59 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-02-28.

Sponsored by Haukeland University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
59 Years to 80 Years
Sex
All
01

Study summary

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
Read the 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

02

Conditions studied

  • Arthritis

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Keywords

  • RSA
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 150 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Haukeland University Hospital is the lead sponsor of 276 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
59 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • arthritis
  • dysplasia

Exclusion criteria

Exclusion Criteria:

  • obesitas
  • charcots
  • paget
  • malignancy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
150 participants (actual)

Study arms

  • Active comparator
    2

    articulation Spectron EF CoCr/ Reflection All-Poly Eto-sterilized

    Device: Spectron Reflection CoCr

  • Active comparator
    3

    articulation Spectron Ef CoCr/ Reflection All-Poly XLPE

    Device: Spectron XLPE CoCr

  • Active comparator
    4

    articulation Spectron EF Oxinium/ Reflection All-Poly Eto-sterilized

    Device: Spectron Reflection Oxinium

  • Active comparator
    5

    articulation Spectron EF Oxinium/ Reflection XLPE

    Device: Spectron XLPE CoCR

  • Active comparator
    1

    articulation Charnley/ Ogee

    Device: charnley OGEE

Interventions

  • Devicecharnley OGEE

    charnley OGEE

  • DeviceSpectron Reflection CoCr

    Spectron Reflection CoCr

  • DeviceSpectron XLPE CoCr

    Spectron XLPE CoCr

  • DeviceSpectron Reflection Oxinium

    Spectron Reflection Oxinium

  • DeviceSpectron XLPE CoCR

    Spectron XLPE CoCR

06

What researchers measure

Primary outcomes

  1. wear

    Time frame: 2 years

Secondary outcomes

  1. migration

    Time frame: 2 years

07

Study locations

1 site
  • Haukeland University Hospital
    Bergen, 50021, Norway
08

References and documents

Individual participant data

Plan to share: No — Not planned

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00698672
Lead sponsor
Haukeland University Hospital
Responsible party
Sponsor
First posted
Jun 17, 2008
Start date
Nov 2004
Primary completion
Jun 2007
Completion
Jun 2017 (estimated)
Last update
Feb 28, 2017

Study contacts

Thomas Kadar, PhD
principal investigator · Haukeland University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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