Physica CR and Physica PS Clinical Trial

Knee Osteoarthritis 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02766231
• Other study ID #: K-09
• Status: Recruiting
• Start date: February 2016
• Est. completion date: December 2026

Study information

• Verified date: September 2023
• Source: Limacorporate S.p.a
• Contact: Federica Azzimonti
• Email: federica.azzimonti[@]limacorporate.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Physica CR
Cruciate tretaining total knee replacement
• Physica PS
Posterior Stabilized total knee replacement

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc ASBL	Bruxelles
Italy	I.R.C.C.S. Galeazzi	Milano
Italy	Casa di cura Citta' di Parma	Parma
Luxembourg	Clinique d'Eich - centre Hospitalier de Luxembourg	Luxembourg

Sponsors (1)

Lead Sponsor	Collaborator
Limacorporate S.p.a

Countries where clinical trial is conducted

Belgium,  Italy,  Luxembourg, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical change in Knee Society Score (KSS)		from preoperative (baseline) to 5 years after surgery
Secondary	Clinical change in Knee Society Score (KSS)		preoperatively (baseline), 3 months, 6 months, 1 year, 2 years, 3 years after surgery
Secondary	Functional change in Timed up and Go (TUG) test		preoperatively (baseline), 3 months, 6 months, 1 year, 2 years, 3 years and 5 years after surgery
Secondary	Change in Knee injury and Osteoarthritis Outcome Score (KOOS)		preoperatively (baseline), 3 months, 6 months, 1 year, 2 years, 3 years and 5 years after surgery
Secondary	Change in Satisfaction Visual Analogue Scale (Satisfaction VAS)		3 months (baseline), 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery
Secondary	Change in Forgotten Joint Score (FJS-12)		3 months (baseline), 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery
Secondary	Thickness and location of symptomatic radiolucent lines		0 months (baseline), 3 months, 6 months, 1 year, 2 years, 3 years and 5 years after surgery
Secondary	Survival rate (Kaplan-Meier)		3 years and 5 years after surgery
Secondary	Incidence of device-related AE/SAE		0 months, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery