Evaluation of Physica TT Tibial Plate in knee replacement patients

A Post Market Clinical Study Evaluating Clinical and Radiographic Outcomes of Total Knee Arthroplasty With Physica Porous KR or Physica Porous PS in Combination With Physica TT Tibial Plate in Cementless Configuration.

This study is testing how well a new type of tibial plate works for people getting knee replacements and if it helps them recover without problems over two years.

Quick facts

• Study type: Observational
• Enrollment: 130 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Limacorporate S.p.a (Industry-sponsored)
• Locations: 3 sites (Forte dei Marmi, Lucca and 2 other locations)
• Trial ID: NCT06337123 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the clinical, radiographic, and patient-reported outcomes of total knee arthroplasty using the Physica TT Tibial Plate in combination with either the Physica Porous KR or Physica Porous PS components. The study aims to assess the performance of these devices up to two years post-surgery, focusing on short-term survivorship of the implant and the incidence of early complications. Participants will be monitored for various outcomes to determine the effectiveness and safety of the devices in knee arthroplasty.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older requiring a total knee replacement due to conditions like knee osteoarthritis or rheumatoid arthritis.

Not a fit: Patients with significant damage to collateral ligaments or those not suitable for total knee replacement may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the effectiveness and safety of the Physica TT Tibial Plate, potentially improving outcomes for patients undergoing knee replacement surgery.

How similar studies have performed: While this study focuses on a specific device, similar studies evaluating knee arthroplasty outcomes have shown promising results, indicating potential for success.

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.

Where this trial is running

Forte dei Marmi, Lucca and 2 other locations

• Casa di Cura San Camillo Hopital — Forte dei Marmi, Lucca, Italy (Recruiting)
• Casa di Cura Carmona — Messina, Italy (Recruiting)
• Istituto Clinico Porta Sole — Perugia, Italy (Recruiting)

Study contacts

• Principal investigator: Alessandro Tripodo — Casa di Cura San Camillo Hospital
• Study coordinator: Domizia Baldassi

Conditions Knee Arthropathy