Registry for Physica Total Knee Replacement

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

This study is testing how well the Physica knee implant works for people getting total knee replacements over the next 10 years.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 800 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Limacorporate S.p.a (Industry-sponsored)
• Locations: 5 sites (Rancho Mirage, California and 4 other locations)
• Trial ID: NCT03048201 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the long-term survivorship of the Physica knee implant system over a period of up to 10 years. It is a multi-center, prospective, non-randomized registry that collects clinical, patient-reported outcomes, and radiographic data from patients undergoing total knee replacement with various configurations of the Physica system. Patients will be assessed pre-operatively and followed up at intervals to monitor their recovery and implant performance. An ancillary subgroup will also be included for additional data collection up to 5 years.

Who should consider this trial

Good fit: Ideal candidates include males and females over 22 years old who require a total knee replacement and have specific knee conditions such as osteoarthritis or traumatic arthritis.

Not a fit: Patients with significant inflammatory arthritis or those who do not meet the eligibility criteria for the Physica system may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of the Physica knee implant system for patients requiring knee replacement.

How similar studies have performed: Other studies on knee replacement implants have shown promising results, indicating that registry-based approaches can yield valuable long-term data.

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

Where this trial is running

Rancho Mirage, California and 4 other locations

• Eisenhower Desert Orthopedics Center - Harry and Diane Rinker Bldg — Rancho Mirage, California, United States (Recruiting)
• The Orthopedics Clinic — Daytona Beach, Florida, United States (Recruiting)
• Rush Castle Orthopaedics — Aurora, Illinois, United States (Recruiting)
• Syracuse Orthopedic Specialists — Syracuse, New York, United States (Completed)
• Joint Reconstructive Specialist — Oklahoma City, Oklahoma, United States (Completed)

Study contacts

• Study coordinator: Fabiana Pavan

Conditions Osteoarthritis, Knee; Traumatic Arthritis; Avascular Necrosis; Degenerative Joint Disease of Knee; Rheumatoid Arthritis; Deformity of Knee; Physica KR; Physica CR