Physica System Total Knee Replacement Registry Study

Description

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, Deformity of Knee

Study Overview

Study Details

Study overview

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.

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

Physica System Total Knee Replacement Registry Study

Condition
Osteoarthritis, Knee
Intervention / Treatment

-

Contacts and Locations

Rancho Mirage

Eisenhower Desert Orthopedics Center - Harry and Diane Rinker Bldg, Rancho Mirage, California, United States, 92270

Daytona Beach

The Orthopedics Clinic, Daytona Beach, Florida, United States, 32117

Aurora

Rush Castle Orthopaedics, Aurora, Illinois, United States, 60504

Syracuse

Syracuse Orthopedic Specialists, Syracuse, New York, United States, 13214

Oklahoma City

Joint Reconstructive Specialist, Oklahoma City, Oklahoma, United States, 73159

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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):
  • 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
  • 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

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Limacorporate S.p.a,

Fabiana Pavan, STUDY_DIRECTOR, Limacorporate S.p.a

Study Record Dates

2030-03