Actively Recruiting

Phase Not Applicable
Age: 22Years +
All Genders
NCT03048201

Physica System Total Knee Replacement Registry Study

Led by Limacorporate S.p.a · Updated on 2023-03-21

800

Participants Needed

5

Research Sites

675 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Physica System Total Knee Replacement Registry Study

Who Can Participate

Age: 22Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  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

Not Eligible

You will not qualify if you...

  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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 5 locations

1

Eisenhower Desert Orthopedics Center - Harry and Diane Rinker Bldg

Rancho Mirage, California, United States, 92270

Actively Recruiting

2

The Orthopedics Clinic

Daytona Beach, Florida, United States, 32117

Actively Recruiting

3

Rush Castle Orthopaedics

Aurora, Illinois, United States, 60504

Actively Recruiting

4

Syracuse Orthopedic Specialists

Syracuse, New York, United States, 13214

Completed

5

Joint Reconstructive Specialist

Oklahoma City, Oklahoma, United States, 73159

Completed

Loading map...

Research Team

F

Fabiana Pavan

CONTACT

F

Federica Azzimonti

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

4

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here