Observational Study to Collect Safety Data and PROMs on Primary THA

Corin116 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

116

Conditions

Hip Arthritis Osteoarthritis, Hip Coxitis Femoral Head Necrosis Femoral Neck Fractures

Interventions

Total hip arthroplasty with a Trinity cup and a Meije Duo cementless stemDEVICE

Subjects clinically suitable for a primary THR surgery with Trinity cup and Meije Duo cementless femoral stem.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

CH Valenciennes

Valenciennes, France

Outcomes

Primary Outcomes

Evaluation of hip functional performance

Improvement of Oxford Hip Score (OHS)

Time frame: 2 years

Secondary Outcomes

Confirmation of safety of the study devices

Number, severity and causal relationship procedure of implant-related adverse events

Time frame: 2 years

Evaluation of outcome after hip arthroplasty

Number, severity and causal relationship procedure of implant-related adverse events

Time frame: 2 years

Evaluation of clinical outcomes

Improvement of Harris Hip Score (HHS)

Time frame: 2 years

Assessment of health-related quality of life

Change of EQ-5D-5L

Time frame: 2 years

Assessment of patient's satisfaction

Improvement of patient's satisfaction following surgery using Self-Administered Patient Satisfaction Scale

Time frame: 2 years

Data from ClinicalTrials.gov

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