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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02321683

Enrollment

Registered

2014-12-22

Start date

2003-12-31

Completion date

2008-12-31

Last updated

2014-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Osteoarthritis

Brief 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.

Interventions

DEVICETaperloc

Femoral stem with electrochemical deposition of hydroxyapatite

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
Early and intermediate periprosthetic bone remodeling	5 years	Bone densitometry measured by DXA
Early and intermediate femoral stem stability	5 years	Radiostereometric analysis of femoral stem movements relative to bone

Secondary

Measure	Time frame	Description
Clinical function	5 years	Hip questionares, Harris Hip Score and Oxford Hip Score
Radiographic signs of loosening	5 years	Conventional x-ray

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026