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This is a observational multicenter study to assess the safety of TIPMED TPM08 Total Knee Prosthesis Systems and TPM Revision Knee Prosthesis Systems used for total knee arthroplasty or revision knee arthroplasty.
In this study, short term (12 months) safety data of TIPMED TPM08 Total Knee Prosthesis System and TPM Revision Knee Prosthesis System will be evaluated using Case Report Forms (CRF). A CRF should be completed at each control visit of the participants by investigator in order to assess safety of the TIPMED Knee Prosthesis Systems by success of operation, occurrence of adverse events during procedure or as the effects in 12 months period resulting from TIPMED Knee Prosthesis Systems. CRF will also include questions related to performance and effectiveness of TIPMED Knee Prosthesis Systems.
Participants should be treated according to instructions-for-use of the implants and accessories and according to clinical routine. The devices must have been used exclusively by physicians who are experienced in knee arthroplasty techniques and who are experienced in using the products in operations.
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| Measure | Description | Time Frame |
|---|---|---|
| Safety data | Assessment of safety data during 12 months after surgery. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
- Subjects in another interventional clinical trial will be excluded.
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All eligible patients, who agree to participate in the study, treated with TIPMED TPM08 Primary Total or Revision Knee Prosthesis Systems will be included.
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| Name | Affiliation | Role |
|---|---|---|
| Salih Kemal Aktuglu | Ege University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Republic of Turkey Ministry of Health Balıkesir Provincial Health Directorate Ataturk City Hospital | Balıkesir | Altıeylül | 10100 | Turkey (Türkiye) |
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| Ege University Hospital | Izmir | Bornova | 35100 | Turkey (Türkiye) |
| Republic of Turkey Ministry of Health Izmir Provincial Health Directorate Buca Seyfi Demirsoy Training And Research Hospital | Izmir | Buca | 35390 | Turkey (Türkiye) |
| Republic of Turkey Ministry of Health Balıkesir Provincial Health Directorate Burhaniye Public Hospital | Balıkesir | Burhaniye | 10700 | Turkey (Türkiye) |
| Republic of Turkey Ministry of Health Izmir Provincial Health Directorate Menemen Public Hospital | Izmir | Menemen | 35660 | Turkey (Türkiye) |