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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:

• Males and females of any race requiring a total knee replacement and suitable for the use of one of the configurations of the Physica system

• Age\> 22 (skeletally mature)

• Patients who are suffering from non-inflammatory degenerative joint disease (NIDJD):

• including knee osteoarthritis, post-traumatic knee arthritis; or patients who are suffering from inflammatory arthritis; or patients that need correction of a functional deformity

• Suitable candidates for TKR who have undamaged and functional collateral ligaments

• Suitable candidates for TKR with Physica KR, CR, who have an undamaged and functional posterior cruciate ligament; or Physica LMC with or without a functioning posterior cruciate ligament or Physica PS with an absent or not-functioning posterior cruciate ligament and/or severe antero-posterior instability of the knee joint

• Patients who understand the conditions of the study and are willing and able to comply with the prescribed rehabilitation and to perform all scheduled follow-up visits

• Patients who have signed the Ethics Committee/IRB approved study-specific Informed Consent Form prior to the surgery

Locations
United States
California
Eisenhower Desert Orthopedics Center - Harry and Diane Rinker Bldg
RECRUITING
Rancho Mirage
Florida
The Orthopedics Clinic
RECRUITING
Daytona Beach
Illinois
Rush Castle Orthopaedics
RECRUITING
Aurora
New York
Syracuse Orthopedic Specialists
COMPLETED
Syracuse
Oklahoma
Joint Reconstructive Specialist
COMPLETED
Oklahoma City
Contact Information
Primary
Fabiana Pavan
Fabiana.Pavan@limacorporate.com
+390432945357
Backup
Federica Azzimonti
federica.azzimonti@limacorporate.com
Time Frame
Start Date: 2017-03-24
Estimated Completion Date: 2030-03
Participants
Target number of participants: 800
Treatments
Other: Physica KR
Subjects that receive the Physica Kinematic Retaining Knee System
Other: Physica CR
Subjects that receive the Physica Cruciate Retaining Knee System
Other: Physica PS
Subjects that receive the Physica Posterior Stabilized Knee System
Other: Physica CR with LMC Liner
Subjects that receive the Physica Cruciate Retaining Knee System with LMC Liner
Sponsors
Leads: Limacorporate S.p.a

This content was sourced from clinicaltrials.gov