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NCT Number: NCT05524350

Assessment of Safety and Performances of HYPE Stems Associated to a SERF Acetabular Cup in Hip Arthroplasty (2017-01-NH)

The use of cementless femoral stems is known to provide satisfactory long-term clinical results. Extensive and durable osseointegration of these implants has been reported in numerous series, despite the use of stems with different geometry and coating distribution.

This study will validate the performance and safety of the HYPE (SERF) stems in the context of the 93/42/EEC directive and in relation to the recommendations of the MEDDEV 2.7.1 (Guideline for post-marketing follow-up), which provides for a systematic procedure for monitoring clinical data in order to verify the performance claimed for medical devices.

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

Rouen University Hospital Center

Rouen, 76000, France

Who can participate

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

Inclusion criteria

  • Male or female
  • Degenerative or inflammatory hip disease requiring total hip replacement
  • Primary or secondary osteoarthritis,
  • Advanced joint destruction resulting from rheumatoid arthritis or traumatic origin,
  • Avascular fracture or necrosis,
  • Displaced subcapital and transcervical fracture as well as PAPROSKY stages I to IIB bone defects.
  • Joint destruction of traumatic origin
  • Following a previous operation, provided that the new device does not interfere with the material in place (osteosynthesis, joint reconstruction, arthrodesis, hemiarthroplasty, total arthroplasty).

Exclusion criteria

  • Patient with a psychological, family, sociological or geographical situation likely to hinder compliance with the study protocol and follow-up
  • Known pregnancy in progress
  • Breastfeeding
  • Patient requiring a bone graft
  • Neurological disorders or other pathology that may influence locomotion
  • History of sepsis in the hip to be operated on
  • Short-term vital prognosis

Treatment and study plan

Primary outcomes

  1. Survival rate

    Time frame: Per operative period to 10 years

    Survival rate for failure at 10 years by studying in particular the intraosseous behaviour of the stem (femoral implant) and of the acetabulum (acetabular or acetabular implant) with the help of radiological examinations: appearance or not of lines, osseointegration, migration, possible loosening, realignment.

Secondary outcomes

  1. Functional improvement

    Time frame: Per operative period to 10 years

    The information will be collected through questionnaires to compare preoperatively situtation to last follow-up situtation

  2. Pain release

    Time frame: Per operative period to 10 years

    The information will be collected through questionnaires to compare preoperatively situtation to last follow-up situtation

  3. Patient satisfaction

    Time frame: Per operative period to 10 years

    The information will be collected from patient through questionnaires to compare preoperatively situtation to last follow-up situtation

  4. Adverse event

    Time frame: Per operative period to 10 years

    Type and occurence of adverse events

Sponsors and collaborators

Lead sponsor

Societe dEtude, de Recherche et de Fabrication

Industry

Registry information

Official study title

Study of the Total Hip Prosthesis With a HYPE Stem in Hip Arthroplasty

Important dates

Study start
2017
Primary completion
2031
Study completion
2031
First posted
Sep 1, 2022
Registry last updated
Apr 24, 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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