Overview

This trial is active, not recruiting.

Condition arthritis
Treatments charnley ogee, spectron reflection cocr, spectron xlpe cocr, spectron reflection oxinium
Sponsor Haukeland University Hospital
Start date November 2004
End date June 2007
Trial size 150 participants
Trial identifier NCT00698672, 10642(NSD), 197.03(REK)

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
articulation Spectron EF CoCr/ Reflection All-Poly Eto-sterilized
spectron reflection cocr
Spectron Reflection CoCr
(Active Comparator)
articulation Spectron Ef CoCr/ Reflection All-Poly XLPE
spectron xlpe cocr
Spectron XLPE CoCr
(Active Comparator)
articulation Spectron EF Oxinium/ Reflection All-Poly Eto-sterilized
spectron reflection oxinium
Spectron Reflection Oxinium
(Active Comparator)
articulation Spectron EF Oxinium/ Reflection XLPE
spectron xlpe cocr
Spectron XLPE CoCR
(Active Comparator)
articulation Charnley/ Ogee
charnley ogee
charnley OGEE

Primary Outcomes

Measure
wear
time frame: 2 years

Secondary Outcomes

Measure
migration
time frame: 2 years

Eligibility Criteria

Male or female participants from 59 years up to 80 years old.

Inclusion Criteria: - arthritis - dysplasia Exclusion Criteria: - obesitas - charcots - paget - malignancy

Additional Information

Official title A Prospective Randomized RSA-Study of Cemented Hip Prostheses With Five Different Articulations
Principal investigator Thomas Kadar, PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Haukeland University Hospital.