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Evaluation of a New Coating in Cement Less Femoral Stems

NCT ID: NCT02321683

Last Updated: 2014-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2008-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hip Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bonemaster

Cement-less femoral stems with electrochemical deposition of hydroxyapatite

Group Type EXPERIMENTAL

Taperloc

Intervention Type DEVICE

Femoral stem with electrochemical deposition of hydroxyapatite

Hydroxyapatite

Cement-less femoral stems with plasmasprayed hydroxyapatite

Group Type ACTIVE_COMPARATOR

Taperloc

Intervention Type DEVICE

Femoral stem with electrochemical deposition of hydroxyapatite

Interventions

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Taperloc

Femoral stem with electrochemical deposition of hydroxyapatite

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zimmer Biomet

INDUSTRY

Sponsor Role collaborator

Lars Nordsletten

OTHER

Sponsor Role lead

Responsible Party

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Lars Nordsletten

Professor Lars Nordsletten

Responsibility Role SPONSOR_INVESTIGATOR

References

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Flatoy B, Rohrl SM, Boe B, Nordsletten L. No medium-term advantage of electrochemical deposition of hydroxyapatite in cementless femoral stems. 5-year RSA and DXA results from a randomized controlled trial. Acta Orthop. 2016 Feb;87(1):42-7. doi: 10.3109/17453674.2015.1084768. Epub 2015 Sep 12.

Reference Type DERIVED
PMID: 26364953 (View on PubMed)

Other Identifiers

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ORTHO.CR.GH30.

Identifier Type: -

Identifier Source: org_study_id