RecruitingNot ApplicableNCT03048201
Physica System Total Knee Replacement Registry Study
Post-market Registry Study on the Physica System Total Knee Replacement
Sponsor
Limacorporate S.p.a
Enrollment
800 participants
Start Date
Mar 24, 2017
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 22 Years
Inclusion Criteria8
- 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
- Age\> 22 (skeletally mature)
- 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
- Suitable candidates for TKR who have undamaged and functional collateral ligaments
- 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
- 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
- Patients who have signed the Ethics Committee/IRB approved study-specific Informed Consent Form prior to the surgery
Exclusion Criteria17
- Patients with severe instability of the knee joint secondary to the absence of collateral ligament integrity and/or function
- Patients with active or any suspected infection (on the affected knee or systemic)
- Previous partial knee replacement (unicompartimental, bicompartimental or patellofemoral joint replacement), patellectomy, high tibial osteotomy
- Patients with significant bone loss on femoral or tibial joint side
- Current treatment for malignant and/or life-threatening non-malignant disorders
- Patients with known incompatibility or allergy to the product materials, and/or metal hypersensitivity to implant materials
- Vascular insufficiency of lower limbs severe enough to interfere with the study evaluation
- Patients with bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation to the prosthesis
- Patients with systemic or metabolic disorders leading to progressive bone deterioration which may impair fixation and stability of the implant
- Any concomitant disease and dependence that might affect the performance of the implanted prosthesis
- 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)
- Patients who have significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery and evaluation
- Patients who have neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device
- Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint
- Any psychiatric illness that would prevent comprehension of the details and nature of the study
- Patients currently participating in any other surgical intervention studies or pain management studies
- Female patients who are pregnant, nursing, or planning a pregnancy
Interventions
DEVICEPhysica Kinematic Retaining Knee System
Modular total knee prosthesis with a Kinematic Retaining mechanism and posterior cruciate ligament (PCL) preservation
DEVICEPhysica Cruciate Retaining Knee System
Total knee prosthesis with posterior cruciate ligament (PCL) preservation
DEVICEPhysica 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.
DEVICEPhysica Cruciate Retaining Knee System with LMC Liner
Total knee prosthesis with posterior cruciate ligament (PCL) preservation
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03048201
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