Observational Study to Collect Safety Data and PROMs on Primary THA

Corin

Status: Terminated

Conditions: Femoral Head Necrosis; Osteoarthritis, Hip; Femoral Neck Fractures; Hip Arthritis; Coxitis

Treatments: Device: Total hip arthroplasty with a Trinity cup and a Meije Duo cementless stem

Study type: Observational

Funder types: Industry

Identifiers

NCT06518993

CSP2022-04

Details and patient eligibility

About

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

Full description

The major goal of this study is to collect safety and patient-reported outcomes measures (PROMs) data on Trinity cup in combination with Meije Duo cementless hip stem when used in primary total hip arthroplasty (THA).

Data collected from this study will be fed into the Post-Market Surveillance (PMS) and Clinical Evaluation processes of the devices under assessment annually and support presentations at orthopaedic congresses and/or peer-reviewed publication(s) on mid- and long-term safety and clinical performance.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.