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Clinical Trials in the USA / NCT03048201
Recruiting Not applicable

Physica System Total Knee Replacement Registry Study

NCT03048201 · tracked via the Priya Life Science USA tracker
Sponsor
Limacorporate S.p.a
Phase
Not applicable
Started
2017-03-24
Last updated
2023-03-21

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

Sex
ALL
Min age
22 Years
Max age
Healthy volunteers
No
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)

Trial sites (5)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03048201 on ClinicalTrials.gov ↗ ← All trials in the USA