Physica System Total Knee Replacement Registry Study

March 17, 2023 updated by: Limacorporate S.p.a

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Rancho Mirage, California, United States, 92270
        • Recruiting
        • Eisenhower Desert Orthopedics Center - Harry and Diane Rinker Bldg
        • Principal Investigator:
          • Erik Schnaser, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ghassan Boghosian, DO
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Recruiting
        • The Orthopedics Clinic
        • Contact:
          • Mark Gillespy, MD
          • Phone Number: 386-255-4596
        • Contact:
          • Sherri Zicker
          • Phone Number: +1-386-255-4596
        • Principal Investigator:
          • Mark Gillespy, MD
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Recruiting
        • Rush Castle Orthopaedics
        • Principal Investigator:
          • Mark Schinsky, MD
        • Contact:
          • Mark Schinsky, MD
          • Phone Number: 630-978-3800
        • Contact:
          • Renee Bergstrom
          • Phone Number: +1-630-978-3800
    • New York
      • Syracuse, New York, United States, 13214
        • Completed
        • Syracuse Orthopedic Specialists
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73159
        • Completed
        • Joint Reconstructive Specialist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Physica KR
Subjects that receive the Physica Kinematic Retaining Knee System
Device: Physica Kinematic Retaining Knee System
Modular total knee prosthesis with a Kinematic Retaining mechanism and posterior cruciate ligament (PCL) preservation
Other: Physica CR
Subjects that receive the Physica Cruciate Retaining Knee System
Device: Physica Cruciate Retaining Knee System
Total knee prosthesis with posterior cruciate ligament (PCL) preservation
Other: Physica PS
Subjects that receive the Physica Posterior Stabilized Knee System
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.
Other: Physica CR with LMC Liner
Subjects that receive the Physica Cruciate Retaining Knee System with LMC Liner
Device: Physica Cruciate Retaining Knee System with LMC Liner
Total knee prosthesis with posterior cruciate ligament (PCL) preservation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Survivorship
Time Frame: 10 years
The primary endpoint is the definition of the implant survivorship of the study device to 10 years after the total knee replacement surgery.
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American Knee Society Score (KSS) 2011
Time Frame: 10 years
Clinical performance assessment measured by overall pain and functionality from baseline to 10-year follow-up
10 years
Patient-Reported Outcome Measures (PROMs)
Time Frame: 10 years
Patient-Reported Outcome Measures (PROMs) including patient satisfaction achievement from baseline to 10-year follow-up
10 years
Radiographic Evaluation
Time Frame: 10 years
• Radiographic implant evaluation and stability assessment from baseline to 10-year follow-up
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Limacorporate S.p.a

Investigators

  • Study Director: Fabiana Pavan, Limacorporate S.p.a

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2017

Primary Completion (Anticipated)

March 1, 2030

Study Completion (Anticipated)

March 1, 2030

Study Registration Dates

First Submitted

February 7, 2017

First Submitted That Met QC Criteria

February 7, 2017

First Posted (Estimate)

February 9, 2017

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 17, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on Physica Kinematic Retaining Knee System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe