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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
800
Modular total knee prosthesis with a Kinematic Retaining mechanism and posterior cruciate ligament (PCL) preservation
Total knee prosthesis with posterior cruciate ligament (PCL) preservation
Total knee prosthesis that sacrifices the posterior cruciate ligament (PCL) and replaces the functionality of the PCL with a post-cam mechanism.
Eisenhower Desert Orthopedics Center - Harry and Diane Rinker Bldg
Rancho Mirage, California, United States
RECRUITINGThe Orthopedics Clinic
Daytona Beach, Florida, United States
RECRUITINGRush Castle Orthopaedics
Aurora, Illinois, United States
Implant Survivorship
The primary endpoint is the definition of the implant survivorship of the study device to 10 years after the total knee replacement surgery.
Time frame: 10 years
American Knee Society Score (KSS) 2011
Clinical performance assessment measured by overall pain and functionality from baseline to 10-year follow-up
Time frame: 10 years
Patient-Reported Outcome Measures (PROMs)
Patient-Reported Outcome Measures (PROMs) including patient satisfaction achievement from baseline to 10-year follow-up
Time frame: 10 years
Radiographic Evaluation
• Radiographic implant evaluation and stability assessment from baseline to 10-year follow-up
Time frame: 10 years
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Total knee prosthesis with posterior cruciate ligament (PCL) preservation
Syracuse Orthopedic Specialists
Syracuse, New York, United States
COMPLETEDJoint Reconstructive Specialist
Oklahoma City, Oklahoma, United States
COMPLETED