Post-market Registry Study on the Physica System Total Knee Replacement
Limacorporate S.p.a
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.
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 Inve…
Eligibility
- Age range
- 22+ years
- Sex
- All
- 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 K…
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)
- Eisenhower Desert Orthopedics Center - Harry and Diane Rinker BldgRancho Mirage, California
- The Orthopedics ClinicDaytona Beach, Florida
- Rush Castle OrthopaedicsAurora, Illinois
- Syracuse Orthopedic SpecialistsSyracuse, New York
- Joint Reconstructive SpecialistOklahoma City, Oklahoma