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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.
Full description
This is a post-market registry study; the study device is FDA cleared and used according to the intended use.
This is a multi-centre, prospective, non-randomized study.
Subjects will be implanted with one of the following configurations of the Physica system: Physica KR (Kinematic Retaining), Physica CR (Cruciate Retaining) or Physica PS (Posterior Stabilized). The assignment of any patient involved in the study is determined by the aetiology preoperatively evaluated by the Investigator and falls within current practice. The decision to use a specific prosthesis design is decided by the Investigators independently and clearly separated from the decision to include the patient in the study.
For the ancillary subgroup, investigators currently contributing to the primary patient group can also enroll additional patients to the ancillary subgroup. 3 existing sites and 2 additional sites are planned to be added to contribute to the additional 300 patients to be enrolled. These patients will follow the same study schedules as the main study, but follow-up is only up to 5 years.
Baseline measurements (pre-operative clinical analysis and radiographic analysis at 6-week FU) will serve as internal control term during the assessment of post-surgery data out to 10 years.
Enrollment
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Volunteers
Inclusion criteria
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 criteria
Primary purpose
Allocation
Interventional model
Masking
800 participants in 4 patient groups
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Central trial contact
Fabiana Pavan; Federica Azzimonti
Data sourced from clinicaltrials.gov
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