Evaluation of a New Coating in Cement Less Femoral Stems

December 17, 2014 updated by: Lars Nordsletten

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bonemaster
Cement-less femoral stems with electrochemical deposition of hydroxyapatite
Device: Taperloc
Femoral stem with electrochemical deposition of hydroxyapatite
Active Comparator: Hydroxyapatite
Cement-less femoral stems with plasmasprayed hydroxyapatite
Device: Taperloc
Femoral stem with electrochemical deposition of hydroxyapatite

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lars Nordsletten

Collaborators

Zimmer Biomet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

December 17, 2014

First Submitted That Met QC Criteria

December 17, 2014

First Posted (Estimate)

December 22, 2014

Study Record Updates

Last Update Posted (Estimate)

December 22, 2014

Last Update Submitted That Met QC Criteria

December 17, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORTHO.CR.GH30.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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