Evaluation of a New Coating in Cement Less Femoral Stems

Lars Nordsletten

Status and phase: Completed; Phase 4

Conditions: Hip Osteoarthritis

Treatments: Device: Taperloc

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02321683

ORTHO.CR.GH30.

Details and patient eligibility

About

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

Full 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.

Enrollment: 55 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Bonemaster

Experimental group

Description:

Cement-less femoral stems with electrochemical deposition of hydroxyapatite

Treatment:

Device: Taperloc

Hydroxyapatite

Active Comparator group

Description:

Cement-less femoral stems with plasmasprayed hydroxyapatite

Treatment:

Device: Taperloc