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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.
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total hip arthroplasty with a Trinity cup and a Meije Duo cementless stem | Device | Subjects clinically suitable for a primary THR surgery with Trinity cup and Meije Duo cementless femoral stem. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of hip functional performance | Improvement of Oxford Hip Score (OHS) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmation of safety of the study devices | Number, severity and causal relationship procedure of implant-related adverse events | 2 years |
| Evaluation of outcome after hip arthroplasty | Number, severity and causal relationship procedure of implant-related adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have undergone to a THA with Trinity cup and Meije Duo cementless hip will be invited to participate in this study. An initial review of the medical database of all Corin Trinity cup procedures performed in the selected study site will be conducted to assess the number of retrospective patients potentially available to join the study. A first contact with the patient will occur telephonically or via mail to explain the study and invite them to join.
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| Name | Affiliation | Role |
|---|---|---|
| Charles BERTON, MD | CH VALENCIENNES | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Valenciennes | Valenciennes | 59300 | France |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D005265 | Femoral Neck Fractures |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| 2 years |
| Evaluation of clinical outcomes | Improvement of Harris Hip Score (HHS) | 2 years |
| Assessment of health-related quality of life | Change of EQ-5D-5L | 2 years |
| Assessment of patient's satisfaction | Improvement of patient's satisfaction following surgery using Self-Administered Patient Satisfaction Scale | 2 years |
| D012216 |
| Rheumatic Diseases |
| D006620 | Hip Fractures |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |