Recruiting
Not applicable
Physica System Total Knee Replacement Registry Study
Condition(s) studied
Osteoarthritis, KneeTraumatic ArthritisAvascular NecrosisDegenerative Joint Disease of KneeRheumatoid ArthritisDeformity of Knee
Investigational drug(s) / intervention(s)
Physica Kinematic Retaining Knee SystemPhysica Cruciate Retaining Knee SystemPhysica Posterior Stabilized Knee SystemPhysica Cruciate Retaining Knee System with LMC Liner
Physica Kinematic Retaining Knee System: Modular total knee prosthesis with a Kinematic Retaining mechanism and posterior cruciate ligament (PCL) preservation
Physica Cruciate Retaining Knee System: Total knee prosthesis with posterior cruciate ligament (PCL) preservation
Physica Posterior Stabilized Knee System: Total knee prosthesis that sacrifices the posterior cruciate ligament (PCL) and replaces the functionality of the PCL with a post-cam mechanism.
Physica Cruciate Retaining Knee System with LMC Liner: Total knee prosthesis with posterior cruciate ligament (PCL) preservation
Study summary
The primary objective of this study is to obtain long-term implant survivorship (out to 10 years) and to assess clinical, patient-reported outcome measures, and radiographic data for the commercially available Physica system. For ancillary arm, from baseline to 5-year follow-up.
Eligibility
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
Primary outcome measure(s)
- Implant Survivorship — 10 years
The primary endpoint is the definition of the implant survivorship of the study device to 10 years after the total knee replacement surgery.
Trial sites (5)
| Facility | City | Region | Status |
| Eisenhower Desert Orthopedics Center - Harry and Diane Rinker Bldg |
Rancho Mirage |
California |
Recruiting |
| The Orthopedics Clinic |
Daytona Beach |
Florida |
Recruiting |
| Rush Castle Orthopaedics |
Aurora |
Illinois |
Recruiting |
| Syracuse Orthopedic Specialists |
Syracuse |
New York |
Completed |
| Joint Reconstructive Specialist |
Oklahoma City |
Oklahoma |
Completed |