Physica CR and Physica PS Clinical Trial

Limacorporate

Status: Enrolling

Conditions: Knee Osteoarthritis

Treatments: Device: Physica PS; Device: Physica CR

Study type: Observational

Funder types: Industry

Identifiers

NCT02766231

K-09

Details and patient eligibility

About

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

Enrollment: 164 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

164 participants in 2 patient groups

Physica CR

Description:

Patients who have undamaged and functional collateral and posterior cruciate ligaments for the group requiring Physica CR

Treatment:

Device: Physica CR

Physica PS

Description:

Patients who have undamaged and functional collateral ligaments for the group requiring Physica PS

Treatment:

Device: Physica PS