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Active, not recruiting Observational

Physica CR and Physica PS Clinical Trial

NCT02766231 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2016-02
Last updated
2026-08-12

Condition(s) studied

Knee Osteoarthritis

Investigational drug(s) / intervention(s)

Physica CRPhysica PS

Physica CR: Cruciate retaining total knee replacement

Physica PS: Posterior Stabilized total knee replacement

Study summary

Type \& Design:

Post-market, international, multicentre Prospective, parallel groups, open-label, baseline controlled

Objectives:

1. Assessment of clinical, radiographic and patient-reported outcomes of Physica CR and PS designs
2. Incidence of adverse events and identification of possible risk factors for unsatisfactory results
3. Mid-term survivorship of the implants

Eligibility

Sex
ALL
Min age
22 Years
Max age
78 Years
Healthy volunteers
No
Inclusion Criteria: 1. Male and females 2. Age 22-78 years 3. Any race 4. Ambulatory patients 5. Patients who have a medical condition with over 5 years of life expectancy 6. Patients with painful primary or secondary knee osteoarthritis 7. Patients who have undamaged and functional collateral and posterior cruciate ligaments for the group requiring Physica CR or Patients who have undamaged and functional collateral ligaments for the group requiring Physica PS 8. Patients with flexion ≥90° on the affected side 9. Patients with a fixed flexion contracture \<20° 10. Patients who understand the conditions of the study and are willing and able to comply with the prescribed rehabilitation and to perform all scheduled follow-up visits 11. Patients who have signed the Ethics Committee approved study-specific Informed Consent Form prior to the surgery Exclusion Criteria: 1. Previous partial knee replacement or patellofemoral joint replacement and previous patellectomy 2. Primary Total Knee Replacement (TKR) in the affected knee 3. Varus deformity \>20° or Valgus deformity \>15° 4. Patients with a fixed flexion contracture \>20° 5. Previous intra-articular fractures of the affected knee 6. Patients with previous methaphysal tibial or femoral osteotomy performed less than 5 years before the screening visit, in case of plate removal surgery it is done early than 1 year ago to screening. 7. Previous knee replacement on the contralateral side within the last year and whose outcome is achieving an KSS\< 60 points 8. Patients with symptomatic Osteoarthritis (OA) of the spine if the assessment of pain with Numeric Rating Scale is \>4 9. Patients with an history of infections (on the affected knee or systemic) 10. Muscular insufficiency or absence of muscoligamentous supporting structures required for adequate soft tissue balance 11. Patients who have damaged or absence of the posterior cruciate ligament for the group requiring Physica CR 12. Patients with known or suspicious metal hypersensitivity 13. Recurrent medical history of severe allergic or immune-mediated reactions 14. Vascular insufficiency of lower limbs severe enough to interfere with the study evaluation 15. Current treatment or treatment within the previous 2 years before the screening visit for malignant and life-threatening non-malignant disorders 16. Any clinically significant pathology based on clinical history that the Investigator feels may affect the study evaluation including: 1. any intercurrent chronic disease or condition that may interfere with the completion of the 5-year follow-up, such as liver disease, severe coronary disease, drug or alcohol abuse 2. significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery 3. neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device 4. known metabolic disorders leading to progressive bone deterioration 17. Patients who have known co-existent medical condition with less 5 years of life expectancy 18. Previous organ transplant surgery 19. Any psychiatric illness that would prevent comprehension of the details and nature of the study 20. Participation in any experimental drug/device study within the 6 months prior to the screening visit 21. Female patients who are pregnant, nursing, or planning a pregnancy

Primary outcome measure(s)

  • Clinical change in Knee Society Score (KSS) — From preoperative (baseline) to 5 years after surgery
    KSS is divided into two components: the first ("Knee Score", KKSS) assesses the knee clinically through the physical examination, and the second ("Function Score", FKSS) assesses the individual's functionality, while both attain a total of 100 points each. The Clinical KSS (KKSS) evaluates pain (50 points), stability (25 points) and range of motion (25 points). The Functional KSS (FKSS) evaluates the walking distance (50 points), and the act of climbing and descending stairs (50 points). The system for selecting patients is provided through three categories: A- unilateral or bilateral (opposite knee replaced successfully), B- unilateral, other knee symptomatic and C- polyarthritis or clinical disease. Scores rating from 80 to 100 is considered excellent, from 70 to 79 good, from 60 to 69 fair, and less than 60 poor.

Trial sites (4)

FacilityCityRegionStatus
Cliniques Universitaires Saint-Luc ASBL Brussels Brussels Capital
I.R.C.C.S. Galeazzi Milan Milano
Casa di cura Citta' di Parma Parma Parma
Clinique d'Eich - centre Hospitalier de Luxembourg Luxembourg Luxembourg

More Limacorporate S.p.a trials in Italy

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02766231 on ClinicalTrials.gov ↗ ← All trials in Italy