Physica TT Tibial Plate Follow up Study
ConditionKnee Arthropathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLimacorporate S.p.a
About this trial
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.
Eligibility criteria
Qualifiers
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.
Non-inflammatory degenerative joint disease like knee osteoarthritis, post traumatic knee arthritis
Inflammatory degenerative joint disease like rheumatoid arthritis
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Device: Physica TT TIbial Plate and Physica Porous KR
- Device: Physica TT TIbial Plate and Physica Porous PS
Treatment groups
130 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov