Physica System Total Knee Replacement Registry Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 22 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. 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. 2. Age> 22 (skeletally mature) 3. 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. 4. Suitable candidates for TKR who have undamaged and functional collateral ligaments. 5. 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. 6. 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. 7. Patients who have signed the Ethics Committee/IRB approved study-specific Informed Consent Form prior to the surgery.

Exclusion Criteria:

1. Patients with severe instability of the knee joint secondary to the absence of collateral ligament integrity and/or function. 2. Patients with active or any suspected infection (on the affected knee or systemic) 3. Previous partial knee replacement (unicompartimental, bicompartimental or patellofemoral joint replacement), patellectomy, high tibial osteotomy. 4. Patients with significant bone loss on femoral or tibial joint side. 5. Current treatment for malignant and/or life-threatening non-malignant disorders. 6. Patients with known incompatibility or allergy to the product materials, and/or metal hypersensitivity to implant materials. 7. Vascular insufficiency of lower limbs severe enough to interfere with the study evaluation. 8. Patients with bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation to the prosthesis. 9. Patients with systemic or metabolic disorders leading to progressive bone deterioration which may impair fixation and stability of the implant. 10. Any concomitant disease and dependence that might affect the performance of the implanted prosthesis. 11. Any clinically significant pathology based on clinical history that the Investigator feels may affect the study evaluation (e.g. primary osteoporosis with significant bone loss, haemophilic disease, septicaemia, persistent acute or chronic osteomyelitis) 12. Patients who have significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery and evaluation. 13. Patients who have neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device. 14. Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint. 15. Any psychiatric illness that would prevent comprehension of the details and nature of the study. 16. Patients currently participating in any other surgical intervention studies or pain management studies. 17. Female patients who are pregnant, nursing, or planning a pregnancy

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03048201
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Limacorporate S.p.a
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Fabiana Pavan
Principal Investigator Affiliation Limacorporate S.p.a
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

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.

Arms & Interventions

Arms

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

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rancho Mirage, California

Status

Recruiting

Address

Eisenhower Desert Orthopedics Center - Harry and Diane Rinker Bldg

Rancho Mirage, California, 92270

Site Contact

Izzy Nunez

[email protected]

760-766-2540

The Orthopedics Clinic, Daytona Beach, Florida

Status

Recruiting

Address

The Orthopedics Clinic

Daytona Beach, Florida, 32117

Site Contact

Mark Gillespy, MD

[email protected]

386-255-4596

Rush Castle Orthopaedics, Aurora, Illinois

Status

Recruiting

Address

Rush Castle Orthopaedics

Aurora, Illinois, 60504

Site Contact

Mark Schinsky, MD

[email protected]

630-978-3800

Syracuse Orthopedic Specialists, Syracuse, New York

Status

Completed

Address

Syracuse Orthopedic Specialists

Syracuse, New York, 13214

Joint Reconstructive Specialist, Oklahoma City, Oklahoma

Status

Completed

Address

Joint Reconstructive Specialist

Oklahoma City, Oklahoma, 73159