Physica System Total Knee Replacement Registry Study

Rheumatoid Arthritis Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT03048201
• Study type: Interventional
• Source: Limacorporate S.p.a
• Contact: Fabiana Pavan
• Phone: +390432945357
• Email: Fabiana.Pavan@limacorporate.com
• Status: Recruiting
• Phase: N/A
• Start date: March 24, 2017
• Completion date: March 2030