Limacorporate S.p.a
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.
Osteoarthritis, Knee
Traumatic Arthritis
Avascular Necrosis
Degenerative Joint Disease of Knee
Rheumatoid Arthritis
Deformity of Knee
Physica Kinematic Retaining Knee System
Physica Cruciate Retaining Knee System
Physica Posterior Stabilized Knee System
Physica Cruciate Retaining Knee System with LMC Liner
NA
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.
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 800 participants |
Masking : | NONE |
Primary Purpose : | TREATMENT |
Official Title : | Post-market Registry Study on the Physica System Total Knee Replacement |
Actual Study Start Date : | 2017-03-24 |
Estimated Primary Completion Date : | 2030-03 |
Estimated Study Completion Date : | 2030-03 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 22 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Eisenhower Desert Orthopedics Center - Harry and Diane Rinker Bldg
Rancho Mirage, California, United States, 92270
RECRUITING
The Orthopedics Clinic
Daytona Beach, Florida, United States, 32117
RECRUITING
Rush Castle Orthopaedics
Aurora, Illinois, United States, 60504
COMPLETED
Syracuse Orthopedic Specialists
Syracuse, New York, United States, 13214
COMPLETED
Joint Reconstructive Specialist
Oklahoma City, Oklahoma, United States, 73159