Osseointegration of Hydroxyapatite-coated Femoral Stems i... | NCT04773145

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

NCT04773145

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Feb 26, 2021Actual

Enrollment

140Estimated

Phase

Not provided

Conditions

Femoral Neck Fractures

Interventions

Hemiarthroplasty with hydroaxyapatite coated stem

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 24, 2021Actual

Primary Completion Date

Mar 24, 2021Estimated

Completion Date

Mar 24, 2021Estimated

First Submitted Date

Feb 24, 2021

First Submission Date that Met QC Criteria

Feb 24, 2021

First Posted Date

Feb 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2021

Last Update Posted Date

Feb 26, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Hemiarthroplasty with hydroaxyapatite coated stem	Procedure	Hemiarthroplasty with non cemented femoral stem, using the hydroxyapatite-coated femoral stem Pharo	Femoral neck fracture

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

80 years
1 year follow-up
femoral neck fracture

Exclusion Criteria:

bad-realized radiographs

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

80 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

All patients over 80 with femoral neck fracture

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mathias Kirsch, Intern	Contact	0782931465		mathias.kirsch@hotmail.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Hôpital Central	Recruiting	Nancy	Lorraine	54000	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005265	Femoral Neck Fractures

Ancestor Terms

ID	Term
D006620	Hip Fractures
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D062785	Hemiarthroplasty

Ancestor Terms

ID	Term
D019643	Arthroplasty, Replacement
D001178	Arthroplasty
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided