Observational Study to Collect Safety Data and Patient-reported Outcomes Measures (PROMs) on Retrospective Primary Total Hip Arthroplasty Surgeries With Trinity Cup and Meije Duo Cementless Hip Stem
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hip Arthritis
- Sponsor
- Corin
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- Evaluation of hip functional performance
- Status
- Terminated
- Last Updated
- 9 months ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Evaluation of hip functional performance
Time Frame: 2 years
Improvement of Oxford Hip Score (OHS)
Secondary Outcomes
- Evaluation of outcome after hip arthroplasty(2 years)
- Evaluation of clinical outcomes(2 years)
- Assessment of health-related quality of life(2 years)
- Assessment of patient's satisfaction(2 years)
- Confirmation of safety of the study devices(2 years)