Physica TT Tibial Plate Prospective Study

ConditionsKnee Arthroplasty, Total Knee Osteoarthritis

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

This trial does not accept healthy volunteers

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 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

Prospective

Treatments tested in this trial

Not listed

Trial groups

142 Participants

are grouped into 1 trial group

Group A: Physica TT Tibial Plate

Trial outcomes

Primary outcomes

Change in Knee Society Score from preoperative to 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