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This prospective clinical study aims at evaluating clinical, radiographic, patient-reported outcomes of total knee arthroplasty with Physica TT Tibial Plate over 2 years after surgery, in order to assess the performance and safety of the devices. Short-term survivorship of the implant and the incidence of early complications are evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physica TT Tibial Plate | Total knee arthroplasty with Physica TT Tibial Plate |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Knee Society Score from preoperative to 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 | From preoperative to 2 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Oxford Knee Score | Overall score from 0 to 48, with 48 being the best outcome | From preoperative to 2 years after surgery |
| Change in Range of Motion | From preoperative to 2 years after surgery |
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Inclusion Criteria:
Patient requiring a total knee arthroplasty (TKA) and suitable for receiving 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
Patient is able to understand the conditions of the study, is willing and able to follow all prescribed rehabilitation as well as willing to perform all scheduled follow-up visits;
Patient has signed the study-specific Informed Consent Form prior to study activities
Exclusion Criteria:
Patient is affected by one or more of the conditions that are stated as Physica contraindications for use, which are:
Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy.
Affected by malignant cancer with life expectancy less than 2 years or where cancer treatment might affect the normal postoperative course.
Any clinically major pathology based on clinical medical history or any medical intervention or reason that the Investigator feels may affect the study evaluation.
Neurological or musculoskeletal disorder or disease that may adversely affect gait, functional recovery and evaluation.
Neuromuscular or neurosensory deficit that would hamper the performance assessment of the device.
Any psychiatric illness that would prevent comprehension of the details and nature of the study.
Simultaneously taking part in another surgical intervention study or pain management study that may affect with clinical study outcomes.
Female patient who is pregnant, nursing, or planning a pregnancy.
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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 | francesca.citossi@enovis.com |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Radiographic implant evaluation and stability assessment | The treated knee is analyzed postoperatively based on knee x-rays. The following parameters are evaluated: - Presence of radiolucent lines - Presence of osteolysis - Presence of loosening - Presence of heterotopic ossification - Presence of periprosthetic fractures | From preoperative to 2 years after surgery |
| Incidence, type and severity of Adverse Device Effects (ADE) and Serious Adverse Device Effects (SADE) | From preoperative to 2 years after surgery |
| Implant survival rate | From preoperative to 2 years after surgery |
| D012216 |
| Rheumatic Diseases |