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
This trial does not accept healthy volunteersQualifiers
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 population
General population of subjects requiring a primary TKR with a diagnosis of painful primary or secondary osteoartrithis not responding to other conservative treatments, after the review of medical history and the radiographic evaluation of the affected knee.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Device: Physica TT TIbial Plate and Physica Porous KR
DeviceDevices: Physica TT Tibial Plate and Physica Porous KR femoral component Data collection of population that underwent total knee arthroplasty with Physica TT Tibial Plate and Physica Porous KR femoral component
Device: Physica TT TIbial Plate and Physica Porous PS
DeviceDevices: Physica TT Tibial Plate and Physica Porous KR femoral component Data collection of population that underwent total knee arthroplasty with Physica TT Tibial Plate and Physica Porous PS femoral component
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: Physica Porous KR femoral component1 intervention
Group B: Physica Porous PS femoral component1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Knee Society Score (KSS) equal or greater than "Good" (score ≥ 70) 2 years after surgery
0-100 scale. Scores rating from 80 to 100 are considered excellent, between 70 and 79 good, between 60 and 69 fair, and less than 60 poor
Time frame
2 years after surgerySecondary outcomes
1
Changes in Range of Motion over time up to 2 years after surgery
Time frame
From preoperative to 2 years after surgery2
Changes in Oxford Knee Score (OKS) over time up to 2 years after surgery.
Overall score from 0 to 48, with 48 being the best outcome
Time frame
From preoperative to 2 years after surgery3
Changes in Forgotten Joint Score (FJS) over time up to 2 years after surgery.
Overall score from 0 to 100, with 100 being the best outcome
Time frame
From preoperative to 2 years after surgery4
Changes in Visual Analogue Scale (VAS) Pain over time up to 2 years after surgery.
100 mm line, with 0 mm being best outcome (no pain) and 100 mm worst outcome (very severe pain)
Time frame
From preoperative to 2 years after surgerySponsors and contacts
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Source ClinicalTrials.gov