RSA-Study of Cemented Hip Prostheses With Five Different Articulations

Not Applicable

• Conditions: Arthritis
• Interventions: Device: Spectron Reflection CoCr; Device: Spectron XLPE CoCR; Device: Spectron Reflection Oxinium; Device: charnley OGEE

• Registration Number: NCT00698672
• Lead Sponsor: Haukeland University Hospital

Brief 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

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 Timeline

• Study Start: 2004-11
• Primary Completion: 2007-06
• Study First Submitted: 2008-06-16
• Study First Submitted QC: 2008-06-16
• Study First Posted: 2008-06-17
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-02-28
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• arthritis
• dysplasia

Exclusion Criteria

• obesitas
• charcots
• paget
• malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Spectron Reflection CoCr	articulation Spectron EF CoCr/ Reflection All-Poly Eto-sterilized
3	Spectron XLPE CoCR	articulation Spectron Ef CoCr/ Reflection All-Poly XLPE
5	Spectron XLPE CoCR	articulation Spectron EF Oxinium/ Reflection XLPE
4	Spectron Reflection Oxinium	articulation Spectron EF Oxinium/ Reflection All-Poly Eto-sterilized
1	charnley OGEE	articulation Charnley/ Ogee

Primary Outcome Measures

Name	Time	Method
wear	2 years

Secondary Outcome Measures

Name	Time	Method
migration	2 years

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Norway