Evaluation of a New Coating in Cement Less Femoral Stems

Lars Nordsletten55 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hip Osteoarthritis

Interventions

TaperlocDEVICE

Femoral stem with electrochemical deposition of hydroxyapatite

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Early and intermediate periprosthetic bone remodeling

Bone densitometry measured by DXA

Time frame: 5 years

Early and intermediate femoral stem stability

Radiostereometric analysis of femoral stem movements relative to bone

Time frame: 5 years

Secondary Outcomes

Clinical function

Hip questionares, Harris Hip Score and Oxford Hip Score

Time frame: 5 years

Radiographic signs of loosening

Conventional x-ray

Time frame: 5 years

Data from ClinicalTrials.gov

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