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The study objective is to evaluate safety and performance of the ORIGIN® PS (postero-stabilized) Modular devices and associated instruments, more precisely to evaluate safety by the proportion of patients requiring a revision (i.e. revision rate) at 2-6 months, 1y and 2y post-procedure and to evaluate performance by means of a Knee Society Score (KSS) Score at 2-6 months, 1y and 2y post procedure.
The hypothesis raised for this study, regarding the scoring, is that patients will experience a marked improvement in the natural feel of the prosthesis during the first year after the surgery, and slightly significant improvement at the following interval of 2 years. The overall patient satisfaction is expected to be improved after 2 years follow-up with ORIGIN® PS Modular.
The study is ambispective, post market, non-comparative, non-randomized, multicentric and observational in which 200 patients will be enrolled to evaluate the safety and performance of the ORIGIN® PS Modular devices and associated instruments.
Patients will be included in the study during 18 months (inclusion window) and followed-up for 24 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORIGIN® PS Modular devices | Device | Consecutive eligible subjects have been included which have been treated with the ORIGIN® PS Modular devices. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate safety by the proportion of required revisions | Proportion of patients requiring a revision at each follow-up visit (surgery, 2-6 months, 1- and 2 years). The revision rate is consistent with the state of the art - Orthopaedic Data Evaluation Panel (ODEP) benchmark system (revision rate not higher than 2.5% to 3.5% at 1 year, 4% to 6% at 5 years and 5% to 7% at 10 years). | 2 years post-op procedure |
| Evaluate performance | Evaluate performance by means of a Knee Society Score (KSS) and a KSS Function score. It aims to reach a KSS Knee score of at least 85,5 / 100 points and a KSS Function score of at least 72,5 / 100 points. | 2 years post-op procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the success of the surgical procedure by means of a surgeon satisfaction questionnaire. | Surgeon satisfaction: during surgery, the surgeon will assess safety and performance of the associated Instrumentation and implants. The criteria of evaluation of the satisfaction are: Very satisfied - satisfied - unsatisfied - very unsatisfied. Each surgical step is evaluated for each instrument and implant component used by the surgeon. These data will be collected in the case report form based on surgeon satisfaction questionnaire and will be used in clinical evaluation of ORIGIN® PS Modular. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have provided consent for the collection of their data and met the protocol eligibility criteria will be enrolled into this observational non-comparative ambispective multicentric study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Polyclinique Medipole Saint Roch | Cabestany | 66330 | France | |||
| Clinique Juge |
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| Perioperative |
| Evaluate safety by analyzing the occurencies of adverse events. |
| Perioperative and 2 years post-op procedure |
| Patient Quality of Life by means of the FJS score | Assess patients' ability to forget their knee in the short term after surgery, as measured by the "Forgotten Knee Score" (FJS-12: from 0 to 100 points, meaning that "0" is worst case and "100" the best). | 2 years post-op procedure |
| Marseille |
| 13008 |
| France |