NCT04773145

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

February 24, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2021

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2021

Completed
Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

28 days

First QC Date

February 24, 2021

Last Update Submit

February 24, 2021

Conditions

Femoral Neck Fractures

Outcome Measures

Primary Outcomes (1)

  • Engh and Massin score

    Measure of the osseointegration

    1 month

Secondary Outcomes (1)

  • CBR

    1 month

Study Arms (1)

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

Interventions

Hemiarthroplasty with hydroaxyapatite coated stemPROCEDURE

Hemiarthroplasty with non cemented femoral stem, using the hydroxyapatite-coated femoral stem Pharo

Femoral neck fracture

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients over 80 with femoral neck fracture

You may qualify if:

  • years
  • year follow-up
  • femoral neck fracture

You may not qualify if:

  • bad-realized radiographs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Hôpital Central

Nancy, Lorraine, 54000, France

RECRUITING

MeSH Terms

Conditions

Femoral Neck Fractures

Interventions

Hemiarthroplasty

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Central Study Contacts

Mathias Kirsch, Intern

CONTACT

0782931465mathias.kirsch@hotmail.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 24, 2021

First Posted

February 26, 2021

Study Start

February 24, 2021

Primary Completion

March 24, 2021

Study Completion

March 24, 2021

Last Updated

February 26, 2021

Record last verified: 2021-02

Locations

FR(1)