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Evaluation of a New Coating in Cement Less Femoral Stems

L

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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