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NCT Number: NCT05524363

Assessment of Safety and Performances of HYPE SCS Stem Associated to NOVAE Sunfit TH Acetabular Cup in Hip Arthroplasty

Total hip arthroplasty is the preferred treatment for hip disease (primary or secondary osteoarthritis, osteonecrosis, for example) and femoral neck fractures.

HYPE SCS stems are intended to be used for primary total hip arthroplasties to reduce pain and restore joint mobility of the hip.

Clinical data for HYPE SCS available are not deemed sufficient to support performance and benefits claimed on the whole lifetime of the product.

Thus, in order to maintain compliance with the EU regulation (2017/745) relating to medical devices and following MEDDEV 2.7.1.guidelines, SERF has set up post-market clinical follow-ups (PMCF). This PMCF study aims to generate clinical data in order to confirm these performance of HYPE SCS Stem associated to NOVAE Sunfit TH acetabular cup. In the meantime, through complications faced over the entire period of the study, risks related to the implantation of HYPE SCS stems will be assessed at medium term (5 years). It should be noted that this patient cohort reflects the usual medical care of Hospital Center "J. Monod" of Flers.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hip Arthropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre hospitalier " J. Monod ",

Flers-en-Escrebieux, 61104, France

Who can participate

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

Inclusion criteria

  • Patients over 18 years old.
  • Patients covered by health insurance system
  • Patients requiring a total hip arthroplasty, implanted swith a femoral stem SCS associated to NOVAE Sunfit TH acetabular cup

Exclusion criteria

  • Patient who expressed opposition to participation in the study and to the use of his personal data
  • Patient unable to understand surgeon's instructions and meet follow-ups requirements
  • Patient presenting a contraindication indicated in the IFU of both implantsw
  • Patient presenting a contraindication to have an X-ray
  • Patients implanted with a femoral stem SCS associated to NOVAE Sunfit TH acetabular cup, in context of off-label use

Treatment and study plan

Primary outcomes

  1. Survival rate according to Kaplan-Meier

    Time frame: per operative period to 5 years

    whatever the cause of revision

Secondary outcomes

  1. Patient satisfaction

    Time frame: per operative period to 5 years

    questionnary with a 4 item-scale

  2. Adverse events

    Time frame: per operative period to 5 years

    Type and occurence of adverse events

  3. Functional improvement

    Time frame: per operative period to 5 years

    This information will be documented through patient questionnary Harris Hip Score

  4. Functional improvement

    Time frame: per operative period to 5 years

    This information will be documented through patient questionnary Devane classification

  5. Pain release

    Time frame: per operative period to 5 years

    This information will be documented through patient questionnary : Harris Hip Score

Sponsors and collaborators

Lead sponsor

Societe dEtude, de Recherche et de Fabrication

Industry

Registry information

Official study title

Prospective and Observational Study of HYPE SCS Stems

Acronym: 2020-04

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Sep 1, 2022
Registry last updated
Apr 22, 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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