RSA-Study of Cemented Hip Prostheses With Five Different Articulations

NCT ID: NCT00698672

Last Updated: 2017-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2017-06-30

Brief Summary

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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

Detailed Description

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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

Conditions

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Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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2

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

Group Type ACTIVE_COMPARATOR

Spectron Reflection CoCr

Intervention Type DEVICE

Spectron Reflection CoCr

3

articulation Spectron Ef CoCr/ Reflection All-Poly XLPE

Group Type ACTIVE_COMPARATOR

Spectron XLPE CoCr

Intervention Type DEVICE

Spectron XLPE CoCr

4

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

Group Type ACTIVE_COMPARATOR

Spectron Reflection Oxinium

Intervention Type DEVICE

Spectron Reflection Oxinium

5

articulation Spectron EF Oxinium/ Reflection XLPE

Group Type ACTIVE_COMPARATOR

Spectron XLPE CoCR

Intervention Type DEVICE

Spectron XLPE CoCR

1

articulation Charnley/ Ogee

Group Type ACTIVE_COMPARATOR

charnley OGEE

Intervention Type DEVICE

charnley OGEE

Interventions

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charnley OGEE

charnley OGEE

Intervention Type DEVICE

Spectron Reflection CoCr

Spectron Reflection CoCr

Intervention Type DEVICE

Spectron XLPE CoCr

Spectron XLPE CoCr

Intervention Type DEVICE

Spectron Reflection Oxinium

Spectron Reflection Oxinium

Intervention Type DEVICE

Spectron XLPE CoCR

Spectron XLPE CoCR

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* arthritis
* dysplasia

Exclusion Criteria

* obesitas
* charcots
* paget
* malignancy
Minimum Eligible Age

59 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Kadar, PhD

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

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Haukeland University Hospital

Bergen, , Norway

Site Status

Countries

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Norway

References

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Johannessen HG, Hallan G, Kadar T, Lie SA, Lygre SHL, Fenstad AM, Haugan K, Hol PJ, Badawy M, Jonsson B, Indrekvam K, Aamodt A, Furnes O. Early cup migration and wear as predictors for later aseptic loosening: a secondary evaluation of a randomized controlled RSA trial on cemented hip arthroplasties with 18-year follow-up. Acta Orthop. 2025 Aug 15;96:618-624. doi: 10.2340/17453674.2025.44328.

Reference Type DERIVED
PMID: 40814981 (View on PubMed)

Other Identifiers

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197.03(REK)

Identifier Type: OTHER

Identifier Source: secondary_id

10642(NSD)

Identifier Type: -

Identifier Source: org_study_id

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