Physica System Total Knee Replacement Registry Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Avascular Necrosis
- Deformity of Knee
- Degenerative Joint Disease of Knee
- Osteoarthritis (Knee)
- Rheumatoid Arthritis
- Traumatic Arthritis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Single Group AssignmentIntervention Model Description: Subjects will receive a commercially available Physica system total knee replacement in one of 3 different configurations: KR (Kinematic Retaining), CR (Cruciate Retaining) and 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.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 22 years and 125 years
- Gender
- Both males and females
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), Physic...
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. 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. The primary objectives of this study are to obtain implant survivorship and to evaluate clinical, PROMs and radiographic outcomes for the commercially available Physica system.
Tracking Information
- NCT #
- NCT03048201
- Collaborators
- Not Provided
- Investigators
- Study Director: Laura Sanchez Limacorporate S.p.a
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