Early Clinical and Radiological Outcomes of Uncemented Fu... | NCT05969366

Studies
Early Clinical and Radiological Outcomes of Uncemented Fully Coated Stem With Patients of 85 Years and More, Complications and Risks Factor

NCT05969366

Sponsor

Central Hospital, Nancy, France

Status

Completed

Last Update Posted

Aug 1, 2023Actual

Enrollment

79Actual

Phase

Not provided

Conditions

Arthroplasty Complications

Interventions

Total hip arthroplasty

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

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015Actual

Primary Completion Date

Apr 2016Actual

Completion Date

Jul 2023Actual

First Submitted Date

Jul 23, 2023

First Submission Date that Met QC Criteria

Jul 23, 2023

First Posted Date

Aug 1, 2023Actual

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

Jul 23, 2023

Last Update Posted Date

Aug 1, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Olivier ROCHE, Praticien Hospitalier, Central Hospital, Nancy, FrancePrincipal Investigator

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Collaborators

Not provided

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

Retrospective, single-centre study. Review of patients aged 85 and over who underwent total hip replacement between June 2015 and February 2022.

This is a femoral stem survival study with calculation of the complication rate in this population.

The study does not focus on total hip replacements in the context of trauma. The secondary endpoint was the search for complication risk factors.

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

79Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients 85 yearsold or orlder who hab total hip replacement with uncemented femoral stem			Procedure: Total hip arthroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Total hip arthroplasty	Procedure		patients 85 yearsold or orlder who hab total hip replacement with uncemented femoral stem

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
rate of complication	survival study, any complications	minimum of 3 months follow up

Secondary Outcomes

Measure	Description	Time Frame
risk factor of complications		minimum of 3 months follow up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

receive total hip arthroplasty with uncemented stem fully hydroxyapatites coated

Exclusion Criteria:

trauma context
less than 3 month follow up
Any surgery of the hip as medical history

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

85 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Any people of 85 years of more who received total hip arthroplasty with uncemented stem fully hydroxyapatitis coated

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Chirurgical Emile Gallé		Nancy		54000	France

Intervention Browse Module

MeSH Terms

ID	Term
D019644	Arthroplasty, Replacement, Hip

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided