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Recruiting Observational

Physica TT Tibial Plate Follow up Study

NCT06337123 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-04-15
Last updated
2026-01-22

Condition(s) studied

Knee Arthropathy

Investigational drug(s) / intervention(s)

Device: Physica TT TIbial Plate and Physica Porous KRDevice: Physica TT TIbial Plate and Physica Porous PS

Device: Physica TT TIbial Plate and Physica Porous KR: 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

Device: Physica TT TIbial Plate and Physica Porous PS: 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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 following conditions: 1. Absent or not-functioning posterior cruciate ligament and severe antero-posterior instability of the knee joint (for Physica Porous PS) 2. Undamaged and functional posterior cruciate ligament (for Physica Porous KR) 5. 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. 6. Patient signed the study-specific informed consent form approved by the ethics committee before study activities Exclusion Criteria: 1. Severe instability of the knee joint secondary to the absence of collateral ligament integrity and/or function. Only for Physica Porous KR: important joint instability and deficiency of posterior cruciate ligament. 2. Any active or suspected infection (local or systemic) or previous history of infection that may affect the prosthetic joint. 3. Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy. 4. Significant bone loss on femoral or tibial joint side. 5. Affected by malignant cancer with life expectancy less than 2 years or where cancer treatment might affect the normal postoperative course. 6. Known incompatibility or allergy to the product materials, and/or metal hypersensitivity to implant materials. 7. Septicaemia. 8. Persistent acute or chronic osteomyelitis. 9. Open epiphyses (immature patient with active bone growth). 10. Necrotic bone 11. Arterial vascular insufficiency or nerve diseases of the lower limbs severe enough to interfere with the study evaluation. 12. Compromised bone stock due to disease, infection or prior implantation that cannot provide adequate support and/or fixation to the prosthesis. 13. Systemic or metabolic disorders leading to progressive bone deterioration, which may impair fixation and stability of the implant. 14. Any concomitant disease and dependency that might affect the performance of the implanted prosthesis. 15. Any clinically major pathology based on clinical medical history or any medical intervention or reason that the Investigator feels may affect the study evaluation. 16. Neurological or musculoskeletal disorder or disease that may adversely affect gait, functional recovery and evaluation. 17. Neuromuscular or neurosensory deficit that would hamper the performance assessment of the device. 18. Any psychiatric illness that would prevent comprehension of the details and nature of the study. 19. Simultaneously taking part in another surgical intervention study or pain management study that may affect with clinical study outcomes. 20. Female patient who is pregnant, nursing, or planning a pregnancy. 21. Important osteoporosis, haemophilic disease. 22. Internistic problems with high risk for surgery.

Primary outcome measure(s)

  • Percentage of Knee Society Score (KSS) equal or greater than "Good" (score ≥ 70) 2 years after surgery — 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

Trial sites (3)

FacilityCityRegionStatus
Casa di Cura San Camillo Hopital Forte dei Marmi Lucca Recruiting
Casa di Cura Carmona Messina Italy Recruiting
Istituto Clinico Porta Sole Perugia Italy Recruiting

More Limacorporate S.p.a trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06337123 on ClinicalTrials.gov ↗ ← All trials in Italy