Physica TT Tibial Plate Follow up Study

Launched by LIMACORPORATE S.P.A · Mar 22, 2024

Keywords

ClinConnect Summary

The Physica TT Tibial Plate Follow Up Study is a clinical trial aimed at understanding how well a specific knee implant works for patients undergoing total knee replacement surgery due to various forms of knee arthritis. The study will evaluate the patients’ recovery and satisfaction over two years after their surgery. Researchers want to see how well the implant performs and to identify any early complications that may arise.

To participate in this study, you need to be at least 18 years old and require a total knee replacement due to conditions like osteoarthritis or rheumatoid arthritis. You should also have a stable knee joint and be able to follow the rehabilitation plan after surgery. If you join, you can expect regular follow-up visits to monitor your progress. It's important to note that certain health conditions may prevent you from participating, such as severe joint instability or active infections. This study is currently recruiting participants of all genders, and your involvement will contribute to understanding how to improve knee replacement surgeries for future patients.

Gender

ALL

Eligibility criteria

• 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.