Physica System Total Knee Replacement Registry Study

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03048201
• Other study ID #: K-11
• Status: Recruiting
• Phase: N/A
• Start date: March 24, 2017
• Est. completion date: March 2030

Study information

• Verified date: March 2023
• Source: Limacorporate S.p.a
• Contact: Fabiana Pavan
• Phone: +390432945357
• Email: Fabiana.Pavan[@]limacorporate.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: March 2030
• Est. primary completion date: March 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Avascular Necrosis
• Deformity of Knee
• Degenerative Joint Disease of Knee
• Joint Diseases
• Necrosis
• Osteoarthritis
• Osteoarthritis, Knee
• Rheumatoid Arthritis
• Traumatic Arthritis

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Rush Castle Orthopaedics	Aurora	Illinois
United States	The Orthopedics Clinic	Daytona Beach	Florida
United States	Joint Reconstructive Specialist	Oklahoma City	Oklahoma
United States	Eisenhower Desert Orthopedics Center - Harry and Diane Rinker Bldg	Rancho Mirage	California
United States	Syracuse Orthopedic Specialists	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
Limacorporate S.p.a

Country where clinical trial is conducted

United States, 

Outcome

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