Physica TT Tibial Plate Prospective Study

NCT06830603 | Not Yet Recruiting

• 1 other identifier: K-41
• Study Type: observational
• Target: 142
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Knee Arthroplasty, Total; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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

  From preoperative to 2 years after surgery

Secondary Outcomes (5)

• Change in Oxford Knee Score

  From preoperative to 2 years after surgery

• Change in Range of Motion

  From preoperative to 2 years after surgery

• Radiographic implant evaluation and stability assessment

  From preoperative to 2 years after surgery

• Incidence, type and severity of Adverse Device Effects (ADE) and Serious Adverse Device Effects (SADE)

  From preoperative to 2 years after surgery

• Implant survival rate

  From preoperative to 2 years after surgery

Study Arms (1)

Physica TT Tibial Plate

Total knee arthroplasty with Physica TT Tibial Plate

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:

• Patient requiring a total knee arthroplasty (TKA) and suitable for receiving 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 such as knee osteoarthritis, post traumatic knee arthritis;
• Inflammatory degenerative joint disease such as rheumatoid arthritis;
• Patient has well-preserved and well-functioning collateral ligaments
• 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;
• Patient has signed the study-specific Informed Consent Form prior to study activities

You may not qualify if:

• 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.
• 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.
• Important osteoporosis, haemophilic disease.
• Internistic problems with high risk for surgery.

Sponsors & Collaborators

• Limacorporate S.p.a: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Domizia Baldassi

CONTACT

+39 3357492586; domizia.baldassi@enovis.com

Francesca Citossi

CONTACT

francesca.citossi@enovis.com

Study Design

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

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 17, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 17, 2025

Record last verified: 2025-02