Post-market Registry Study on the Physica System Total Knee Replacement

This is a post-market registry study; the study device is FDA cleared and used according to
the intended use.

This is a multi-centre, prospective, non-randomized study.

Subjects will be implanted with one of the following configurations of the Physica system:
Physica KR (Kinematic Retaining), Physica CR (Cruciate Retaining) or Physica PS (Posterior
Stabilized). The assignment of any patient involved in the study is determined by the
aetiology preoperatively evaluated by the Investigator and falls within current practice. The
decision to use a specific prosthesis design is decided by the Investigators independently
and clearly separated from the decision to include the patient in the study.

Baseline measurements (pre-operative clinical analysis and radiographic analysis at 6-week
FU) will serve as internal control term during the assessment of post-surgery data out to 10
years.

The primary objectives of this study are to obtain implant survivorship and to evaluate
clinical, PROMs and radiographic outcomes for the commercially available Physica system.

Inclusion Criteria:

1. Males and females of any race requiring a total knee replacement and suitable for the
use of one of the configurations of the Physica system

2. Age> 22 (skeletally mature)

3. Patients who are suffering from non-inflammatory degenerative joint disease (NIDJD):
including knee osteoarthritis, post-traumatic knee arthritis; or patients who are
suffering from inflammatory arthritis; or patients that need correction of a
functional deformity

4. Suitable candidates for TKR who have undamaged and functional collateral ligaments

5. Suitable candidates for TKR with Physica KR and CR who have an undamaged and
functional posterior cruciate ligament; or suitable candidates for TKR using Physica
PS with an absent or not-functioning posterior cruciate ligament and/or severe
antero-posterior instability of the knee joint and received the study device at the
time of surgery

6. 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

7. Patients who have signed the Ethics Committee/IRB approved study-specific Informed
Consent Form prior to the surgery

Exclusion Criteria:

1. Patients with severe instability of the knee joint secondary to the absence of
collateral ligament integrity and/or function

2. Patients with active or any suspected infection (on the affected knee or systemic)

3. Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral
joint replacement), patellectomy, high tibial osteotomy

4. Patients with significant bone loss on femoral or tibial joint side

5. Current treatment for malignant and/or life-threatening non-malignant disorders

6. Patients with known incompatibility or allergy to the product materials, and/or metal
hypersensitivity to implant materials

7. Vascular insufficiency of lower limbs severe enough to interfere with the study
evaluation

8. Patients with bone stock compromised by disease, infection or prior implantation that
cannot provide adequate support and/or fixation to the prosthesis

9. Patients with systemic or metabolic disorders leading to progressive bone
deterioration which may impair fixation and stability of the implant

10. Any concomitant disease and dependence that might affect the performance of the
implanted prosthesis

11. Any clinically significant pathology based on clinical history that the Investigator
feels may affect the study evaluation (e.g. primary osteoporosis with significant bone
loss, haemophilic disease, septicaemia, persistent acute or chronic osteomyelitis)

12. Patients who have significant neurological or musculoskeletal disorders or disease
that may adversely affect gait and compromise functional recovery and evaluation

13. Patients who have neuromuscular or neurosensory deficit which would limit the ability
to assess the performance of the device

14. Previous history of infection in the affected joint and/or other local/systemic
infection that may affect the prosthetic joint

15. Any psychiatric illness that would prevent comprehension of the details and nature of
the study

16. Patients currently participating in any other surgical intervention studies or pain
management studies

17. Female patients who are pregnant, nursing, or planning a pregnancy