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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00698672
Other study ID # 10642(NSD)
Secondary ID 197.03(REK)
Status Active, not recruiting
Phase N/A
First received June 16, 2008
Last updated February 27, 2017
Start date November 2004
Est. completion date June 2017

Study information

Verified date February 2017
Source Haukeland University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 150
Est. completion date June 2017
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender All
Age group 59 Years to 80 Years
Eligibility Inclusion Criteria:

- arthritis

- dysplasia

Exclusion Criteria:

- obesitas

- charcots

- paget

- malignancy

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Norway Haukeland University Hospital Bergen

Sponsors (1)

Lead Sponsor Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary wear 2 years
Secondary migration 2 years
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