Physica System Total Knee Replacement Registry Study

Launched by LIMACORPORATE S.P.A · Feb 7, 2017

Keywords

ClinConnect Summary

The Physica System Total Knee Replacement Registry Study is a clinical trial aimed at understanding how well the Physica knee replacement system works over a long period, specifically up to 10 years. Researchers want to gather information on how patients feel after surgery, as well as gather medical images and other data to help assess the implant's performance. This study is currently recruiting participants who are at least 22 years old and in need of a total knee replacement due to various conditions affecting the knee, such as osteoarthritis or traumatic injuries.

To be eligible, participants should have healthy ligaments in their knees and be able to follow the study's guidelines, including rehabilitation and follow-up visits. Those who have certain health issues, previous knee surgeries, or infections are not eligible. If you join this study, you can expect regular check-ups and support throughout the process as researchers gather valuable information that could help improve knee replacement surgeries in the future.

Gender

ALL

Eligibility criteria

• 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, CR, who have an undamaged and functional posterior cruciate ligament; or Physica LMC with or without a functioning posterior cruciate ligament or Physica PS with an absent or not-functioning posterior cruciate ligament and/or severe antero-posterior instability of the knee joint
• • 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 (unicompartimental, bicompartimental 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