Clinical trial NCT02766231: Physica CR and Physica PS Clinical Trial
Official title: A Multicentre, Prospective Study Evaluating Clinical, Radiographic and Patient-reported Outcomes of Total Knee Arthroplasty With Physica CR or Physica PS Prosthesis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Knee Osteoarthritis
Keywords: knee replacement
Lead sponsor: Limacorporate S.p.a
Sponsor class: INDUSTRY
First posted: 2016-05-09
Enrollment: 157
Sex: ALL
Minimum age (years): 22
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: 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.

Brief 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 criteria: 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 outcomes:
measure: Clinical change in Knee Society Score (KSS)
timeFrame: From preoperative (baseline) to 5 years after surgery
Secondary outcomes:
measure: Functional change in Timed up and Go (TUG) test
timeFrame: From preoperative (baseline) to 5 years after surgery
measure: Change in Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: From preoperative (baseline) to 5 years after surgery
measure: Change in Satisfaction Visual Analogue Scale (Satisfaction VAS)
timeFrame: From 3 months to 5 years after surgery
measure: Change in Forgotten Joint Score (FJS-12)
timeFrame: From 3 months to 5 years after surgery
measure: Components stability - radiolucent lines evaluation
timeFrame: From discharge to 5 years after surgery
measure: Survival rate of Physica CR and PS
timeFrame: At 3 years and 5 years after surgery
measure: Incidence of device-related AE/SAE/DD/ADE/SADE
timeFrame: From intraoperative to 5 years after surgery
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc ASBL
city: Milano
country: Italy
facility: I.R.C.C.S. Galeazzi
city: Parma
country: Italy
facility: Casa di cura Citta' di Parma
city: Luxembourg
country: Luxembourg
facility: Clinique d'Eich - centre Hospitalier de Luxembourg
Study officials:
affiliation: I.R.C.C.S. Galeazzi (Milan, Italy)
name: Giuseppe Peretti, MD
role: PRINCIPAL_INVESTIGATOR
References: