Evaluation of a New Coating in Cement Less Femoral Stems

Hip Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02321683
• Other study ID #: ORTHO.CR.GH30.
• Status: Completed
• Phase: Phase 4
• First received: December 17, 2014
• Last updated: December 17, 2014
• Start date: December 2003
• Est. completion date: December 2008

Study information

• Verified date: December 2014
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethic
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2008
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• non-inflammatory hip arthritis, life expectancy of at least 10 years and hip anatomy allowing the use of standard implants

Exclusion Criteria:

• infection, revision surgery, severe morbidity and obvious bone loss

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis, Hip

Intervention

Device:
• Taperloc
Femoral stem with electrochemical deposition of hydroxyapatite

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Lars Nordsletten	Biomet, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early and intermediate periprosthetic bone remodeling	Bone densitometry measured by DXA	5 years	No
Primary	Early and intermediate femoral stem stability	Radiostereometric analysis of femoral stem movements relative to bone	5 years	No
Secondary	Clinical function	Hip questionares, Harris Hip Score and Oxford Hip Score	5 years	No
Secondary	Radiographic signs of loosening	Conventional x-ray	5 years	No