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The Effect of Implant Coating (BoneMaster) on Migration and Clinical Outcome in Hip Arthroplasty With the Exceed Cup

Osteoarthritis Clinical Trial

Official title:
The Effect of Implant Coating With Hydroxyapatite Deposited Electrochemically (BoneMaster) on Migration and Clinical Outcome in Hip Arthroplasty With the Exceed Cup

Clinical Trial Summary

This study focuses on the effect of the hydroxyapatite coating with BoneMaster on the fixation of the hip prosthesis in primary hip alloplasty. A hemispheric joint cup of the type Exceed cup (Biomet) characterized by a porous surface of titanium plasma spray is used. The surface is coated with hydroxyapatite deposited electrochemically (BoneMaster) and will be compared with an identical cup without hydroxyapatite.

Clinical Trial Description

This study focuses on the effect of the hydroxyapatite coating with BoneMaster on the fixation of the hip prosthesis in primary hip alloplasty. A hemispheric joint cup of the type Exceed cup (Biomet) characterized by a porous surface of titanium plasma spray is used. The surface is coated with hydroxyapatite deposited electrochemically (BoneMaster) and will be compared with an identical cup without hydroxyapatite. A 5-year radiologic analysis of migration will be carried out with the object of detecting prognostic evidence of prosthesis loosening. Migration is determined by Roentgen Stereo-photogrammetric Analysis (RSA) on stereoroentgenography. Simultaneously, the patients will be monitored by using the clinical outcome measure HOOS (Hip disability and osteoarthritis outcome score), OHS (Oxford Hip Score), EQ-5D (EuroQol), HHS (Harris Hip Score) on range of motion, VAS (Visual Analog Scale), postoperative complications and reoperation. Hypothesis: We expect that the Exceed cup with hydroxyapatite deposited electrochemically (BoneMaster) is superior or equal compared to a similar cup without hydroxyapatite regarding - mechanical stability (RSA) - (clinical outcome) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02311179
Study type Interventional
Source University of Aarhus
Contact
Status Active, not recruiting
Phase N/A
Start date January 2013
Completion date August 2024
View Details
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