Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
130 participants
OBSERVATIONAL
2025-04-15
2029-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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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
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
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Limacorporate S.p.a
INDUSTRY
Responsible Party
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Principal Investigators
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Alessandro Tripodo
Role: PRINCIPAL_INVESTIGATOR
Casa di Cura San Camillo Hospital
Locations
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Casa di Cura San Camillo Hopital
Forte dei Marmi, Lucca, Italy
Casa di Cura Carmona
Messina, , Italy
Istituto Clinico Porta Sole
Perugia, , Italy
Countries
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Central Contacts
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Facility Contacts
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Alessandro Tripodo
Role: primary
Marcello La Bruna
Role: primary
Stefano Lignini
Role: primary
Other Identifiers
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K-38
Identifier Type: -
Identifier Source: org_study_id
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