Post-marketing Surveillance Study of the Saphir Stem in P... | NCT05649007

Studies
Post-marketing Surveillance Study of the Saphir Stem in Primary Hip Surgery

NCT05649007

Sponsor

Gruppo Bioimpianti S.r.l.

Status

Recruiting

Last Update Posted

Dec 13, 2022Actual

Enrollment

630Estimated

Phase

Not provided

Conditions

Arthropathy of Hip

Interventions

hip arthroplasty with prosthesis

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

Dec 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 30, 2022Actual

Primary Completion Date

Sep 30, 2035Estimated

Completion Date

Sep 30, 2036Estimated

First Submitted Date

Dec 2, 2022

First Submission Date that Met QC Criteria

Dec 12, 2022

First Posted Date

Dec 13, 2022Actual

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

Dec 12, 2022

Last Update Posted Date

Dec 13, 2022Actual

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

Post-market clinical follow up investigation on the use of saphir stem and FIN Cup or Dualis system in the treatment of pathologies requiring hip arthroplasty. The main object of the clinical investigation is the evaluation of long term survival rate of Saphir stem.

Detailed Description

The main object of the clinical investigation is the evaluation of Stem (SAPHIR) survival rate. The post market clinical follow up will also consider as further seconday endpoints: improvement of paient function, quality of life, safety of device (intended as possible adverse events related to the use of the prosthesis)

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

630Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hip arthroplasty with prosthesis	Device	Use of femoral stem and acetabular cup for hip arthroplasty

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
stem survival rate	Kaplan Meier survival analysis	1 year, 3 years, 5 and 10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients>18 years
Candidate for primary total hip replacement with femoral stem and acetabular cup
if ostheoarthritis patients aged 18 to 85 years
if femoral neck fracture patients aged 18 to 90 years
patients with social security scheme
patients understands the condition of the study and is willing to partecipate for the duration of the clinical investigation
patients who gavee consent to partecipare in the clinical investigation

Exclusion Criteria:

<18 years
if female, pregnant
patient who has already had primary hip surgery on the same side
local or disseminated neoplastic disease
inability to understand the study and agree to partecipate
patients cancelling partecipation before surgery
patients under guardianship or curatorship
patients without a social security scheme
patients refusing to partecipate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

please see inclusion/exclusion criteria

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alessio Vitale, Biotech	Contact	+390251650371		regulatory@bioimpianti.it
Fabio Stringhi, biomedic eng	Contact	patients under guardianship or		fabio.stringhi@bioimpianti.it

Overall Officials

Name	Affiliation	Role
Gerard Giordano, medicine	Hopital Ducuing	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Ducuing	Recruiting	Toulouse			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