NCT03048201

Physica System Total Knee Replacement Registry Study

Post-market Registry Study on the Physica System Total Knee Replacement

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Limacorporate S.p.a · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Osteoarthritis, Knee
• Traumatic Arthritis
• Avascular Necrosis
• Degenerative Joint Disease of Knee
• Rheumatoid Arthritis
• Deformity of Knee

Interventions

Type	Name	Description
DEVICE	Physica Kinematic Retaining Knee System	Modular total knee prosthesis with a Kinematic Retaining mechanism and posterior cruciate ligament (PCL) preservation
DEVICE	Physica Cruciate Retaining Knee System	Total knee prosthesis with posterior cruciate ligament (PCL) preservation
DEVICE	Physica 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.
DEVICE	Physica Cruciate Retaining Knee System with LMC Liner	Total knee prosthesis with posterior cruciate ligament (PCL) preservation

Timeline

• Start date: 2017-03-24
• Primary completion: 2030-03-01
• Completion: 2030-03-01
• First posted: 2017-02-09
• Last updated: 2023-03-21

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study