MedDataX Logo

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

NCT ID: NCT05649007

Last Updated: 2022-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

630 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-30

Study Completion Date

2036-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arthropathy of Hip

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

hip arthroplasty with prosthesis

Use of femoral stem and acetabular cup for hip arthroplasty

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gruppo Bioimpianti S.r.l.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gerard Giordano, medicine

Role: PRINCIPAL_INVESTIGATOR

Hopital Ducuing

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hopital Ducuing

Toulouse, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Alessio Vitale, Biotech

Role: CONTACT

Phone: +390251650371

Email: [email protected]

Fabio Stringhi, biomedic eng

Role: CONTACT

Phone: patients under guardianship or

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Gerard Giordano

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PRCS202201

Identifier Type: -

Identifier Source: org_study_id