Recruiting

Knee Replacement

Sponsor:

Limacorporate S.p.a

Code:

NCT03048201

Conditions

Osteoarthritis, Knee

Traumatic Arthritis

Avascular Necrosis

Degenerative Joint Disease of Knee

Rheumatoid Arthritis

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Physica Kinematic Retaining Knee System

Physica Cruciate Retaining Knee System

Physica Posterior Stabilized Knee System

Physica Cruciate Retaining Knee System with LMC Liner

Study Details

Brief 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.

Conditions

Osteoarthritis, Knee

Traumatic Arthritis

Avascular Necrosis

Degenerative Joint Disease of Knee

Rheumatoid Arthritis

Study ID

NCT03048201

Start date

Mar 24, 2017

Status verified date

Mar, 2023

Completion date

Mar, 2030

Anticipated

Primary completion date

Mar, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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 Design

Enrollment

800 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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

Physica Kinematic Retaining Knee System

Modular total knee prosthesis with a Kinematic Retaining mechanism and posterior cruciate ligament (PCL) preservation

Physica Cruciate Retaining Knee System

Total knee prosthesis with posterior cruciate ligament (PCL) preservation

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.

Physica Cruciate Retaining Knee System with LMC Liner

Total knee prosthesis with posterior cruciate ligament (PCL) preservation

Primary outcome measure

  • Implant Survivorship [ Time Frame: 10 years ]

Central Contacts and Locations

Locations

Eisenhower Desert Orthopedics Center - Harry and Diane Rinker Bldg

Recruiting

Rancho Mirage, California, United States, 92270

Contacts

Principal Investigator:

Erik Schnaser, MD

The Orthopedics Clinic

Recruiting

Daytona Beach, Florida, United States, 32117

Contacts

Mark Gillespy, MD

386-255-4596

Sherri Zicker

+1-386-255-4596

Principal Investigator:

Mark Gillespy, MD

Rush Castle Orthopaedics

Recruiting

Aurora, Illinois, United States, 60504

Contacts

Mark Schinsky, MD

630-978-3800

Renee Bergstrom

+1-630-978-3800

Principal Investigator:

Mark Schinsky, MD

More Information

Sponsor

Limacorporate S.p.a

Last update posted

Mar 21, 2023

Last verified

Mar, 2023

Keywords

  • Physica KR
  • Physica CR
  • Physica PS
  • Kinematic Retaining
  • Cruciate Retaining
  • Posterior Stabilized
  • Physica System

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Limacorporate S.p.a on 2023-03-21.