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Physica TT Tibial Plate Prospective Study | Clinical Trials | Clareo Health

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Physica TT Tibial Plate Prospective Study

A Post Market, Prospective Clinical Study Evaluating Clinical and Radiographic Outcomes of Patients Undergoing Total Knee Arthroplasty with Physica TT Tibial Plate

NCT06830603•Limacorporate S.p.a

View on ClinicalTrials.gov

Summary

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient requiring a total knee arthroplasty (TKA) and suitable for receiving Physica TT Tibial Plate;
•2. Age ≥ 18 years old;
•3. Candidate for primary total knee replacement when clinical indications based on physical examination and medical history include one or more of the following conditions:
•1. Non-inflammatory degenerative joint disease such as knee osteoarthritis, post traumatic knee arthritis;
•2. Inflammatory degenerative joint disease such as rheumatoid arthritis;
•4. Patient has well-preserved and well-functioning collateral ligaments
•5. Patient is able to understand the conditions of the study, is willing and able to follow all prescribed rehabilitation as well as willing to perform all scheduled follow-up visits;
•6. Patient has signed the study-specific Informed Consent Form prior to study activities

Exclusion Criteria

•1. Patient is affected by one or more of the conditions that are stated as Physica contraindications for use, which are:
•* 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.
•* 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.
+13 more criteria

Key Dates

Start Date

May 1, 2025

Primary Completion Date

December 1, 2028

Completion Date

December 1, 2028

Last Updated

February 17, 2025

Enrollment

142

ESTIMATED participants

Conditions

Knee Arthroplasty, TotalKnee Osteoarthritis

Contacts

Domizia Baldassi

CONTACT

+39 3357492586 domizia.baldassi@enovis.com

Francesca Citossi

CONTACT

francesca.citossi@enovis.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Physica TT Tibial Plate Prospective Study

Inclusion Criteria

Exclusion Criteria

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