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Completed

NCT Number: NCT06465940

Observational Ambispective Study on HYPE Cups Associated With HIPER Liner

This study intend to collect data on total hip arthroplasty performed with HYPE cups used with conventional polyethylene liner (HIPER).

Medical Device Regulation 2017/745 regulation required proper clinical data to support claims. This study is therefore intended to provide data on HYPE devices to comply with Medical Device Regulation2047/745 regulation.

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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 de la Côte Basque

Bayonne, 64109, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient was an adult at surgery,
  • Patient implanted with HYPE® acetabular cup and HIPER liner,
  • Patient was followed-up at least once on retrospective part of the study,
  • Patient's current social security affiliation is valid.

Exclusion criteria

  • Patient refuses the use of his/her personal data,
  • Patient is unable to follow surgeon's instruction or unavailable for follow-up,
  • Patient with contraindication to x-rays,
  • Patient not implanted with HYPE® acetabular cup and HIPER liner.

Treatment and study plan

Total hip arthroplasty

Device

Replacement of hip joint

Primary outcomes

  1. Functional score

    Time frame: per operative period to at least 2 year

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

Secondary outcomes

  1. Patient satisfaction

    Time frame: per operative period to at least 2 year

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

  2. Safety adverse event

    Time frame: per operative period to at least 2 year

    Type and occurence of adverse events

  3. Survival rate

    Time frame: per operative period to at least 2 year

    Kaplan-Meier survival rates of cups and liners

Sponsors and collaborators

Lead sponsor

Societe dEtude, de Recherche et de Fabrication

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 20, 2024
Registry last updated
Jun 20, 2024

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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