Physica TT Tibial Plate Follow up Study
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 co
| Condition(s) | Knee Arthropathy |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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. |
| Who can participate | Inclusion Criteria: 1. 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. 2. Age ≥ 18 years old. 3. Candidate for primary total knee replacement when clinical indications based on physical examination and medical history include one or more of the following conditions: 1. Non-inflammatory degenerative joint disease like knee osteoarthritis, post traumatic knee arthritis 2. Inflammatory degenerative joint disease like rheumatoid arthritis 3. Any other medical reason for which the investigator deems the subject as a possible candidate for total knee replacement. 4. Patient has well-preserved and well-functioning collateral ligaments and one of the |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Limacorporate S.p.a |
| Locations | Forte dei Marmi, Lucca, Italy; Messina, Italy; Perugia, Italy |
| Start date | 2025-04-15 |
| NCT ID | NCT06337123 |
| Official listing | https://clinicaltrials.gov/study/NCT06337123 |