Physica TT Tibial Plate Follow up Study

Recruiting now

Conditions studied: Knee Arthropathy

In brief

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.

Key facts

Study ID

NCT06337123

Run by

Limacorporate S.p.a

People needed

130

Starts

2025-04-15

Expected to finish

2029-04-01

Last updated by the study team

2026-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Age ≥ 18 years old.
• Candidate for primary total knee replacement when clinical indications based on physical examination and medical history include one or more of the following conditions:
• Non-inflammatory degenerative joint disease like knee osteoarthritis, post traumatic knee arthritis
• Inflammatory degenerative joint disease like rheumatoid arthritis
• Any other medical reason for which the investigator deems the subject as a possible candidate for total knee replacement.
• Patient has well-preserved and well-functioning collateral ligaments and one of the following conditions:
• Absent or not-functioning posterior cruciate ligament and severe antero-posterior instability of the knee joint (for Physica Porous PS)
• Undamaged and functional posterior cruciate ligament (for Physica Porous KR)
• 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.
• Patient signed the study-specific informed consent form approved by the ethics committee before study activities

You may not qualify if…

• 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.
• Any active or suspected infection (local or systemic) or previous history of infection that may affect the prosthetic joint.
• Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy.
• Significant bone loss on femoral or tibial joint side.
• Affected by malignant cancer with life expectancy less than 2 years or where cancer treatment might affect the normal postoperative course.
• Known incompatibility or allergy to the product materials, and/or metal hypersensitivity to implant materials.
• Septicaemia.
• Persistent acute or chronic osteomyelitis.
• Open epiphyses (immature patient with active bone growth).
• Necrotic bone
• Arterial vascular insufficiency or nerve diseases of the lower limbs severe enough to interfere with the study evaluation.
• Compromised bone stock due to disease, infection or prior implantation that cannot provide adequate support and/or fixation to the prosthesis.
• Systemic or metabolic disorders leading to progressive bone deterioration, which may impair fixation and stability of the implant.
• Any concomitant disease and dependency that might affect the performance of the implanted prosthesis.
• Any clinically major pathology based on clinical medical history or any medical intervention or reason that the Investigator feels may affect the study evaluation.
• Neurological or musculoskeletal disorder or disease that may adversely affect gait, functional recovery and evaluation.
• Neuromuscular or neurosensory deficit that would hamper the performance assessment of the device.
• Any psychiatric illness that would prevent comprehension of the details and nature of the study.
• Simultaneously taking part in another surgical intervention study or pain management study that may affect with clinical study outcomes.
• Female patient who is pregnant, nursing, or planning a pregnancy.
• Important osteoporosis, haemophilic disease.
• Internistic problems with high risk for surgery.

Where it is running

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

Full record on ClinicalTrials.gov

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