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OpenTrials
Completed

NCT Number: NCT02321683

Evaluation of a New Coating in Cement Less Femoral Stems

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

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Key information

Conditions

Hip Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Taperloc

Device

Femoral stem with electrochemical deposition of hydroxyapatite

Primary outcomes

  1. Early and intermediate periprosthetic bone remodeling

    Time frame: 5 years

    Bone densitometry measured by DXA

  2. Early and intermediate femoral stem stability

    Time frame: 5 years

    Radiostereometric analysis of femoral stem movements relative to bone

Secondary outcomes

  1. Clinical function

    Time frame: 5 years

    Hip questionares, Harris Hip Score and Oxford Hip Score

  2. Radiographic signs of loosening

    Time frame: 5 years

    Conventional x-ray

Sponsors and collaborators

Lead sponsor

Lars Nordsletten

Other

Collaborators

  • Zimmer Biomet

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2005
Study completion
2008
First posted
Dec 22, 2014
Registry last updated
Dec 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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