RSA-Study of Cemented Hip Prostheses With Five Different Articulations

Haukeland University Hospital

Status: Unknown

Conditions: Arthritis

Treatments: Device: charnley OGEE; Device: Spectron XLPE CoCR; Device: Spectron Reflection Oxinium; Device: Spectron Reflection CoCr; Device: Spectron XLPE CoCr

Study type: Interventional

Funder types: Other

Identifiers

NCT00698672

10642(NSD)

197.03(REK) (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 150 patients

Sex: All

Ages: 59 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• arthritis
• dysplasia

Exclusion criteria

• obesitas
• charcots
• paget
• malignancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 5 patient groups

2

Active Comparator group

Description:

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

Treatment:

Device: Spectron Reflection CoCr

3

Active Comparator group

Description:

articulation Spectron Ef CoCr/ Reflection All-Poly XLPE

Treatment:

Device: Spectron XLPE CoCr

4

Active Comparator group

Description:

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

Treatment:

Device: Spectron Reflection Oxinium

5

Active Comparator group

Description:

articulation Spectron EF Oxinium/ Reflection XLPE

Treatment:

Device: Spectron XLPE CoCR

1

Active Comparator group

Description:

articulation Charnley/ Ogee

Treatment:

Device: charnley OGEE