TerminatedNot Applicable

Observational Study to Collect Safety Data and PROMs on Primary THA

Stopped: The current study was prematurely terminated as part of a strategic decision to consolidate resources and incorporate the Trinity implant into another ongoing PMCF study which was initiated to meet updated regulatory requirements.

France116 participantsStarted 2024-04-19

Plain-language summary

This observational study is designed to collect safety data and PROMs on retrospective primary total hipa arthroplasty surgeries with Trinity cup and Meije Duo cementless hip system

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Both genders. * Adult subjects. * Subjects who received a primary THR with Trinity cup and Meije Duo cementless femoral stem. * The subject is willing to comply with the required follow-up visits as per protocol. * The subject has signed a Patient Informed Consent Form (PICF), specific to this study, and approved by the local EC. Exclusion Criteria: * Subjects under guardianship. * Subjects in the opinion of the Investigator/ investigative team who will be unable to comply with study procedures (Examples: recent psychotic or mania disorders, alcohol, drug or substance abusers) and/or those unable for any medical or other reason to comply with study procedures/visits.

What they're measuring

Evaluation of hip functional performance

Timeframe: 2 years

Trial details

NCT IDNCT06518993

SponsorCorin

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-06-20

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