Physica TT Tibial Plate Follow up Study

NCT06337123 | Recruiting

• 1 other identifier: K-38
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 3

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.

Conditions

Knee Arthropathy

Outcome Measures

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

  2 years after surgery

Secondary Outcomes (7)

• 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

Study Arms (2)

Physica Porous KR femoral component

Devices: Physica TT Tibial Plate and Physica Porous KR femoral component Total knee arthroplasty with Physica TT Tibial Plate and Physica Porous KR femoral component

Device: Device: Physica TT TIbial Plate and Physica Porous KR

Physica Porous PS femoral component

Devices: Physica TT Tibial Plate and Physica Porous PS femoral component Total knee arthroplasty with Physica TT Tibial Plate and physica Porous PS femoral component

Device: Device: Physica TT TIbial Plate and Physica Porous PS

Interventions

Device: Physica TT TIbial Plate and Physica Porous KR DEVICE

Devices: 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

Physica Porous KR femoral component

Device: Physica TT TIbial Plate and Physica Porous PS DEVICE

Devices: 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

Physica Porous PS femoral component

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.
• Patient signed the study-specific informed consent form approved by the ethics committee before study activities

You may not qualify if:

• 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
• Arterial vascular insufficiency or nerve diseases of the lower limbs severe enough to interfere with the study evaluation.
• Compromised bone stock due to disease, infection or prior implantation that cannot provide adequate support and/or fixation to the prosthesis.
• Systemic or metabolic disorders leading to progressive bone deterioration, which may impair fixation and stability of the implant.
• Any concomitant disease and dependency that might affect the performance of the implanted prosthesis.
• Any clinically major pathology based on clinical medical history or any medical intervention or reason that the Investigator feels may affect the study evaluation.

Sponsors & Collaborators

• Limacorporate S.p.a: lead

Study Sites (3)

Casa di Cura San Camillo Hopital

Forte dei Marmi, Lucca, 55042, Italy

RECRUITING

Casa di Cura Carmona

Messina, 98100, Italy

RECRUITING

Istituto Clinico Porta Sole

Perugia, 06100, Italy

RECRUITING

Study Officials

• Alessandro Tripodo

  Casa di Cura San Camillo Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Domizia Baldassi

CONTACT

+39 3357492586; domizia.baldassi@enovis.com

Francesca Citossi

CONTACT

+39 335 1640260; francesca.citossi@enovis.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 29, 2024
• Study Start: April 15, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

IT (3)