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This clinical study aims at evaluating clinical, radiographic, patient-reported outcomes of total knee arthroplasty with Physica TT Tibial Plate in combination with Physica Porous KR or Physica Porous PS up to 2 years after surgery, in order to assess the performance of the devices. Furthermore, ithe objective is to collect short-term survivorship of the implant and the incidence of early complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physica Porous KR femoral component | Devices: Physica TT Tibial Plate and Physica Porous KR femoral component Total knee arthroplasty with Physica TT Tibial Plate and Physica Porous KR femoral component |
| |
| Physica Porous PS femoral component | Devices: Physica TT Tibial Plate and Physica Porous PS femoral component Total knee arthroplasty with Physica TT Tibial Plate and physica Porous PS femoral component |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device: Physica TT TIbial Plate and Physica Porous KR | Device | Devices: Physica TT Tibial Plate and Physica Porous KR femoral component Data collection of population that underwent total knee arthroplasty with Physica TT Tibial Plate and Physica Porous KR femoral component |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Knee Society Score (KSS) equal or greater than "Good" (score ≥ 70) 2 years after surgery | 0-100 scale. Scores rating from 80 to 100 are considered excellent, between 70 and 79 good, between 60 and 69 fair, and less than 60 poor | 2 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Range of Motion over time up to 2 years after surgery | From preoperative to 2 years after surgery | |
| Changes in Oxford Knee Score (OKS) over time up to 2 years after surgery. | Overall score from 0 to 48, with 48 being the best outcome |
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Inclusion Criteria:
Male or female of any race requiring a total knee replacement (TKR) and suitable for receiving Physica Porous KR or Physica Porous PS femoral component in combination with Physica TT Tibial Plate.
Age ≥ 18 years old.
Candidate for primary total knee replacement when clinical indications based on physical examination and medical history include one or more of the following conditions:
Patient has well-preserved and well-functioning collateral ligaments and one of the following conditions:
Patient is able to understand the conditions of the study, to comply with the prescribed rehabilitation as well as willing to perform all scheduled follow-up visits.
Patient signed the study-specific informed consent form approved by the ethics committee before study activities
Exclusion Criteria:
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General population of subjects requiring a primary TKR with a diagnosis of painful primary or secondary osteoartrithis not responding to other conservative treatments, after the review of medical history and the radiographic evaluation of the affected knee.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Domizia Baldassi | Contact | +39 3357492586 | domizia.baldassi@enovis.com | |
| Francesca Citossi | Contact | +39 335 1640260 | francesca.citossi@enovis.com |
| Name | Affiliation | Role |
|---|---|---|
| Alessandro Tripodo | Casa di Cura San Camillo Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Casa di Cura San Camillo Hopital | Recruiting | Forte dei Marmi | Lucca | 55042 | Italy |
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| Device: Physica TT TIbial Plate and Physica Porous PS | Device | Devices: Physica TT Tibial Plate and Physica Porous KR femoral component Data collection of population that underwent total knee arthroplasty with Physica TT Tibial Plate and Physica Porous PS femoral component |
|
| From preoperative to 2 years after surgery |
| Changes in Forgotten Joint Score (FJS) over time up to 2 years after surgery. | Overall score from 0 to 100, with 100 being the best outcome | From preoperative to 2 years after surgery |
| Changes in Visual Analogue Scale (VAS) Pain over time up to 2 years after surgery. | 100 mm line, with 0 mm being best outcome (no pain) and 100 mm worst outcome (very severe pain) | From preoperative to 2 years after surgery |
| Radiographic implant evaluation and stability assessment from postoperative (baseline) over time up to 2 years after surgery | The treated knee is analyzed postoperatively based on anteroposterior and lateral x-rays view of the knee. The following parametner are evaluated:
| From preoperative to 2 years after surgery |
| Survival rate (Kaplan-Meier) at 2 years after surgery | From preoperative to 2 years after surgery |
| Incidence, type and severity of Adverse Device Effects (ADE) and Serious Adverse Device Effects (SADE) up to 2 years follow up | From preoperative to 2 years after surgery |
| Casa di Cura Carmona | Recruiting | Messina | 98100 | Italy |
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| Istituto Clinico Porta Sole | Recruiting | Perugia | 06100 | Italy |
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