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NCT Number: NCT05956236

Hip Prospective Study

In an evaluation report dated 2014, the HAS (Haute Autorité de Santé -French National Authority for Health) highlights that long-term clinical data on hip prostheses are needed in the context of the French healthcare system. In addition, per the European Regulation 2017/745, medical devices manufacturers shall conduct Post-Market Clinical Follow-up (PMCF) on their devices or provide a justification why PMCF is not applicable.

Therefore, as part of the PMCF process of their hip prostheses, SERF wants to conduct a PMCF investigation to ensure the long-term real-life performance, safety and benefits of these prostheses.

HiPS is a non-comparative, prospective, multicentric, national, 15-year follow-up clinical investigation.

Recruiting

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Key information

Conditions

Hip Arthropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU St Etienne

Saint-Priest-en-Jarez, 42270, France

Location status: Recruiting

Location contact

Boyer Bertrand

CONTACT

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female adults
  • Planned to be implanted with investigational medical devices per the IFUs:
  • Implantation in skeletally mature adults (usually aged 60-65 and over), with an extremely painful and/or disabled joint and insufficiently improved by alternative treatment options after an observation period lasting from a few weeks to a few months
  • Implantation of investigational medical devices as integrated systems (all components from SERF, no component from another manufacturer)
  • For an intended purpose and indication listed in the IFUs
  • Affiliated to French social security
  • Who provided a dated and signed informed consent form

Exclusion criteria

  • Patient protected by a French legal measure
  • Patient not able to express his/her consent as deemed by the investigator
  • Patient deprived of liberty or hospitalized without consent
  • Pregnant or breastfeeding women
  • Patient contraindicated to investigational medical devices implantation per the IFUs
  • Patient contraindicated to radiographic follow-up
  • Patient a priori not able to meet the follow-up visits as deemed by the investigator
  • Patient not able to fulfil a self-assessment questionnaire as deemed by the investigator.

Treatment and study plan

Primary outcomes

  1. Survival rate

    Time frame: Per operative period to 15 years

    To assess the survival rate of the investigational medical devices at the end of their claimed implantation duration

Secondary outcomes

  1. Intermediate survival rates

    Time frame: Per operative period to 10 years

    To assess the survival rate of the investigational medical devices at the intermediate timepoints

  2. Functional improvement

    Time frame: Per operative period to 15 years

    To assess the evolution of patient's functional capacity post-implantation using HOOS score

  3. Functional improvement

    Time frame: Per operative period to 15 years

    To assess the evolution of patient's functional capacity post-implantation using Harris Hips score

  4. Functional improvement

    Time frame: Per operative period to 15 years

    To assess the evolution of patient's activity post-implantation using UCLA scale

  5. Functional improvement

    Time frame: Per operative period to 15 years

    To assess the evolution of patient's activity post-implantation using Charnley score

  6. Leg length discrepancy

    Time frame: Pre operative period to 15 years

    To assess patient's leg length discrepancy post-implantation (visual evaluation)

  7. Patient's Pain

    Time frame: Pre operative period to 15 years

    To assess patient's pain (Visual Analogic Scale)

  8. Patient's quality of life

    Time frame: Pre operative period to 15 years

    To assess patient's quality of life post-implantation (Forgotten Joint Score)

  9. Patient's satisfaction

    Time frame: Post operative period to 15 years

    To assess patients' satisfaction with the operation (4-points question)

  10. Surgeon's satisfaction

    Time frame: Per operative period to 15 years

    To assess surgeons' satisfaction with the operation

  11. Adverse events

    Time frame: Per operative period to 15 years

    To assess the long-term safety of investigational medical devices as well as post-operative safety of the surgery

Study contacts

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

Clinical department

CONTACT

[email protected]

0472056010 ext. +33

Sponsors and collaborators

Lead sponsor

Societe dEtude, de Recherche et de Fabrication

Industry

Registry information

Official study title

Hip Prospective Study: Long-term Post-market Clinical Follow-up on the Use of SERF Hip Prostheses

Important dates

Study start
2023
Primary completion
2046
Study completion
2046
First posted
Jul 21, 2023
Registry last updated
Apr 14, 2026

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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