Osseointegration of Hydroxyapatite-coated Femoral Stems in Femoral Neck Fractures Over 80 Years

February 24, 2021 updated by: Didier MAINARD, Central Hospital, Nancy, France

This study aimes to prove that osseointegration of hydroxyapatite coated stem is possible for patients over 80 years with femoral neck fracture, without the risks of cemented stems.

The hydroxyapatite has a local effect which can improve cortical index.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Lorraine
      • Nancy, Lorraine, France, 54000
        • Recruiting
        • CHU Hôpital Central

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

80 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients over 80 with femoral neck fracture

Description

Inclusion Criteria:

  • 80 years
  • 1 year follow-up
  • femoral neck fracture

Exclusion Criteria:

  • bad-realized radiographs

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Femoral neck fracture
Patients over 80 years when suffering of femoral neck fracture with at least one year follow-up.
Procedure: Hemiarthroplasty with hydroaxyapatite coated stem
Hemiarthroplasty with non cemented femoral stem, using the hydroxyapatite-coated femoral stem Pharo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Engh and Massin score
Time Frame: 1 month
Measure of the osseointegration
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CBR
Time Frame: 1 month
Mesure of level of osteoporosis
1 month

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

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 (ACTUAL)

February 24, 2021

Primary Completion (ANTICIPATED)

March 24, 2021

Study Completion (ANTICIPATED)

March 24, 2021

Study Registration Dates

First Submitted

February 24, 2021

First Submitted That Met QC Criteria

February 24, 2021

First Posted (ACTUAL)

February 26, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 26, 2021

Last Update Submitted That Met QC Criteria

February 24, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020PI257

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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