Clinical Trials Directory

Trials / Completed

CompletedNCT02321683

Evaluation of a New Coating in Cement Less Femoral Stems

No Mid-term Advantage by Electrochemical Deposition of Hydroxyl-apatite in Cementless Femoral Stems. 5-year RSA and DXA Results From a Randomized Controlled Trial

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
55 (actual)
Sponsor
Lars Nordsletten · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

The purpose of this trial is to evaluate a new method of applying hydroxyapatite coatings on cement-less femoral stems.

Detailed description

60 patients eligible for total hip replacement will be randomized in to two groups, receiving either femoral stems with plasma sprayed hydroxyapatite coating or stems with electrochemically deposited hydroxyapatite. This patients will be followed for at least 5 years. The outcome is evaluated by comparing stability measured by RSA and periprosthetic bone remodeling measured by bone densitometry.

Conditions

Interventions

TypeNameDescription
DEVICETaperlocFemoral stem with electrochemical deposition of hydroxyapatite

Timeline

Start date
2003-12-01
Primary completion
2005-06-01
Completion
2008-12-01
First posted
2014-12-22
Last updated
2014-12-22

Source: ClinicalTrials.gov record NCT02321683. Inclusion in this directory is not an endorsement.