Physica System Total Knee Replacement Registry Study

Not Applicable

Recruiting

• Conditions: Deformity of Knee; Avascular Necrosis; Degenerative Joint Disease of Knee; Rheumatoid Arthritis; Traumatic Arthritis; Osteoarthritis, Knee
• Interventions: Device: Physica Cruciate Retaining Knee System; Device: Physica Posterior Stabilized Knee System; Device: Physica Kinematic Retaining Knee System; Device: Physica Cruciate Retaining Knee System with LMC Liner

• Registration Number: NCT03048201
• Lead Sponsor: Limacorporate S.p.a

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.

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 Timeline

• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-09
• Study Start: 2017-03-24
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-17
• Last Update Posted: 2023-03-21
• Primary Completion: 2030-03
• Study Completion: 2030-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Physica CR	Physica Cruciate Retaining Knee System	Subjects that receive the Physica Cruciate Retaining Knee System
Physica PS	Physica Posterior Stabilized Knee System	Subjects that receive the Physica Posterior Stabilized Knee System
Physica KR	Physica Kinematic Retaining Knee System	Subjects that receive the Physica Kinematic Retaining Knee System
Physica CR with LMC Liner	Physica Cruciate Retaining Knee System with LMC Liner	Subjects that receive the Physica Cruciate Retaining Knee System with LMC Liner

Primary Outcome Measures

Name	Time	Method
Implant Survivorship	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.

Secondary Outcome Measures

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

Trial Locations

Locations (5)

The Orthopedics Clinic; 🇺🇸 Daytona Beach, Florida, United States

Rush Castle Orthopaedics; 🇺🇸 Aurora, Illinois, 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, United States