Physica TT Tibial Plate Prospective Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLimacorporate S.p.a
About this trial
This prospective clinical study aims at evaluating clinical, radiographic, patient-reported outcomes of total knee arthroplasty with Physica TT Tibial Plate over 2 years after surgery, in order to assess the performance and safety of the devices. Short-term survivorship of the implant and the incidence of early complications are evaluated.
Eligibility criteria
Qualifiers
Patient requiring a total knee arthroplasty (TKA) and suitable for receiving Physica TT Tibial Plate;
Age ≥ 18 years old;
Non-inflammatory degenerative joint disease such as knee osteoarthritis, post traumatic knee arthritis;
Inflammatory degenerative joint disease such as rheumatoid arthritis;
Disqualifiers
Severe instability of the knee joint secondary to the absence of collateral ligament integrity and/or function.
Any active or suspected infection (local or systemic) or previous history of infection that may affect the prosthetic joint.
Significant bone loss on femoral or tibial joint side.
Known incompatibility or allergy to the product materials, and/or metal hypersensitivity to implant materials.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
142 Participants
are grouped into 1 trial groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov