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NCT04773145 Clinical Trial

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

Femoral Neck Fractures Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04773145
Other study ID # 2020PI257
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 24, 2021
Est. completion date March 24, 2021

Study information
Verified date February 2021
Source Central Hospital, Nancy, France
Contact Mathias Kirsch, Intern
Phone 0782931465
Email mathias.kirsch@hotmail.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 140
Est. completion date March 24, 2021
Est. primary completion date March 24, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 80 Years and older
Eligibility Inclusion Criteria: - 80 years - 1 year follow-up - femoral neck fracture Exclusion Criteria: - bad-realized radiographs

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Hemiarthroplasty with hydroaxyapatite coated stem
Hemiarthroplasty with non cemented femoral stem, using the hydroxyapatite-coated femoral stem Pharo

Locations
Country Name City State
France CHU Hôpital Central Nancy Lorraine

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Engh and Massin score Measure of the osseointegration 1 month
Secondary CBR Mesure of level of osteoporosis 1 month
See also
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