A Post Market Clinical Study Evaluating Clinical and Radiographic Outcomes of Total Knee Arthroplasty With Physica Porous KR or Physica Porous PS in Combination With Physica TT Tibial Plate in Cementless Configuration.

Limacorporate S.p.a3 sites in 1 country130 target enrollmentApril 15, 2025

ConditionsKnee Arthropathy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Knee Arthropathy
Sponsor: Limacorporate S.p.a
Enrollment: 130
Locations: 3
Primary Endpoint: Percentage of Knee Society Score (KSS) equal or greater than "Good" (score ≥ 70) 2 years after surgery
Status: Recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 15, 2025

End Date

April 1, 2029

Last Updated

3 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Limacorporate S.p.a

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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

Outcomes

Primary Outcomes

Percentage of Knee Society Score (KSS) equal or greater than "Good" (score ≥ 70) 2 years after surgery

Time Frame: 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

Secondary Outcomes

Survival rate (Kaplan-Meier) at 2 years after surgery(From preoperative to 2 years after surgery)
Incidence, type and severity of Adverse Device Effects (ADE) and Serious Adverse Device Effects (SADE) up to 2 years follow up(From preoperative to 2 years after surgery)
Changes in Range of Motion over time up to 2 years after surgery(From preoperative to 2 years after surgery)
Changes in Oxford Knee Score (OKS) over time up to 2 years after surgery.(From preoperative to 2 years after surgery)
Changes in Forgotten Joint Score (FJS) over time up to 2 years after surgery.(From preoperative to 2 years after surgery)
Changes in Visual Analogue Scale (VAS) Pain over time up to 2 years after surgery.(From preoperative to 2 years after surgery)
Radiographic implant evaluation and stability assessment from postoperative (baseline) over time up to 2 years after surgery(From preoperative to 2 years after surgery)