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NCT Number: NCT05649007

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

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.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Ducuing

Toulouse, France

Location status: Recruiting

Location contact

Gerard Giordano

CONTACT

[email protected]

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hip arthroplasty with prosthesis

Device

Use of femoral stem and acetabular cup for hip arthroplasty

Primary outcomes

  1. stem survival rate

    Time frame: 1 year, 3 years, 5 and 10 years

    Kaplan Meier survival analysis

Study contacts

Contact information is provided by the study sponsor or research team.

Alessio Vitale, Biotech

CONTACT

[email protected]

+390251650371

Fabio Stringhi, biomedic eng

CONTACT

[email protected]

patients under guardianship or

Sponsors and collaborators

Lead sponsor

Gruppo Bioimpianti S.r.l.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2035
Study completion
2036
First posted
Dec 13, 2022
Registry last updated
Dec 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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