Coxitis, Femoral Head Necrosis, Femoral Neck Fractures, Hip Arthritis, Osteoarthritis, Hip
Conditions
Keywords
total hip arthroplasty
Brief 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
Detailed 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.
Interventions
DEVICETotal hip arthroplasty with a Trinity cup and a Meije Duo cementless stem
Subjects clinically suitable for a primary THR surgery with Trinity cup and Meije Duo cementless femoral stem.
Sponsors
Corin
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of hip functional performance | 2 years | Improvement of Oxford Hip Score (OHS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Confirmation of safety of the study devices | 2 years | Number, severity and causal relationship procedure of implant-related adverse events |
| Evaluation of outcome after hip arthroplasty | 2 years | Number, severity and causal relationship procedure of implant-related adverse events |
| Evaluation of clinical outcomes | 2 years | Improvement of Harris Hip Score (HHS) |
| Assessment of health-related quality of life | 2 years | Change of EQ-5D-5L |
| Assessment of patient's satisfaction | 2 years | Improvement of patient's satisfaction following surgery using Self-Administered Patient Satisfaction Scale |
Countries
France
Outcome results
None listed