Clinical trial NCT03048201: Physica System Total Knee Replacement Registry Study
Official title: Post-market Registry Study on the Physica System Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Traumatic Arthritis
Avascular Necrosis
Degenerative Joint Disease of Knee
Rheumatoid Arthritis
Deformity of Knee
Keywords: Physica KR
Physica CR
Physica PS
Kinematic Retaining
Cruciate Retaining
Posterior Stabilized
Physica System
Lead sponsor: Limacorporate S.p.a
Sponsor class: INDUSTRY
First posted: 2017-02-09
Enrollment: 800
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Subjects will receive a commercially available Physica system total knee replacement in one of 3 different configurations: KR (Kinematic Retaining), CR (Cruciate Retaining) and 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Implant Survivorship
timeFrame: 10 years
Secondary outcomes:
measure: American Knee Society Score (KSS) 2011
timeFrame: 10 years
measure: Patient-Reported Outcome Measures (PROMs)
timeFrame: 10 years
measure: Radiographic Evaluation
timeFrame: 10 years
Other outcomes:
Locations:
city: Rancho Mirage
country: United States
facility: Eisenhower Desert Orthopedics Center - Harry and Diane Rinker Bldg
state: California
city: Daytona Beach
country: United States
facility: The Orthopedics Clinic
state: Florida
city: Aurora
country: United States
facility: Rush Castle Orthopaedics
state: Illinois
city: Syracuse
country: United States
facility: Syracuse Orthopedic Specialists
state: New York
city: Oklahoma City
country: United States
facility: Joint Reconstructive Specialist
state: Oklahoma
Study officials:
affiliation: Limacorporate S.p.a
name: Fabiana Pavan
role: STUDY_DIRECTOR
References: