Physica System Total Knee Replacement Registry Study
- NCT ID
- NCT03048201
- Registry status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Limacorporate S.p.a
- Conditions
- Avascular Necrosis, Deformity of Knee, Degenerative Joint Disease of Knee, Osteoarthritis, Knee, Rheumatoid Arthritis, Traumatic Arthritis
Overview
ClinicalTrials.gov lists this study as Recruiting.
Official title: Post-market Registry Study on the Physica System Total Knee Replacement
Enrollment: 800 participants (Estimated).
What is being studied
- Device: Physica Cruciate Retaining Knee System
- Device: Physica Cruciate Retaining Knee System with LMC Liner
- Device: Physica Kinematic Retaining Knee System
- Device: Physica Posterior Stabilized Knee System
Who may be eligible
- Ages
- 22 Years to no maximum
- Sex
- All
- Healthy volunteers accepted
- No
ClinicalTrials.gov lists the following 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
Study locations
5 study locations are listed.
Recruiting site status is explicitly provided for 5 locations; 3 are listed as Recruiting.
Countries: United States
- California, United States: 1
- Florida, United States: 1
- Illinois, United States: 1
- New York, United States: 1
- Oklahoma, United States: 1
Sample of listed locations
- Eisenhower Desert Orthopedics Center - Harry and Diane Rinker Bldg — Rancho Mirage, California, 92270, United States — Recruiting
- The Orthopedics Clinic — Daytona Beach, Florida, 32117, United States — Recruiting
- Rush Castle Orthopaedics — Aurora, Illinois, 60504, United States — Recruiting
- Syracuse Orthopedic Specialists — Syracuse, New York, 13214, United States — Completed
- Joint Reconstructive Specialist — Oklahoma City, Oklahoma, 73159, United States — Completed
Study details
- Start date
- March 24, 2017
- Primary completion date
- March 1, 2030
- Completion date
- March 1, 2030
- First posted
- February 9, 2017
Source and update information
- Source
- ClinicalTrials.gov
- NCT ID
- NCT03048201
- Registry last updated
- March 21, 2023
- QualifiedStudies registry data refreshed
- October 2, 2026
- QualifiedStudies record fetched
- October 2, 2026
View NCT03048201 on ClinicalTrials.gov
Trial information can change. Confirm current study details with the study team or the registry.
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