RecruitingNot ApplicableNCT03048201

Physica System Total Knee Replacement Registry Study

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


Sponsor

Limacorporate S.p.a

Enrollment

800 participants

Start Date

Mar 24, 2017

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This registry study tracks the long-term safety and performance of the Physica total knee replacement implant in patients who have received it for knee joint disease, collecting data on outcomes, complications, and patient recovery over time. **You may be eligible if...** - You are 22 or older (skeletally mature) and need a total knee replacement - You have knee arthritis (osteoarthritis, post-injury arthritis, or inflammatory arthritis) or need correction of a knee deformity - You are scheduled to receive the Physica knee replacement system - You are willing and able to attend follow-up visits and complete your rehabilitation program **You may NOT be eligible if...** - You have an active or suspected infection (in the knee or elsewhere in the body) - You have had a partial knee replacement, kneecap removal, or certain prior knee surgeries - You have significant bone loss or bone disease in the knee - You have a severe neurological condition affecting your ability to walk or recover - You are pregnant, nursing, or planning a pregnancy - You are currently enrolled in another surgical or pain management study - You have a known allergy to the implant materials (such as certain metals) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Bldg

Rancho Mirage, California, United States

The Orthopedics Clinic

Daytona Beach, Florida, United States

Rush Castle Orthopaedics

Aurora, Illinois, United States

Syracuse Orthopedic Specialists

Syracuse, New York, United States

Joint Reconstructive Specialist

Oklahoma City, Oklahoma, United States

View Full Details on ClinicalTrials.gov

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NCT03048201


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