Physica System Total Knee Replacement Registry Study

NCT03048201 | Recruiting FDA Device

• 1 other identifier: K-11
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 5

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• American Knee Society Score (KSS) 2011

  10 years

• Patient-Reported Outcome Measures (PROMs)

  10 years

• Radiographic Evaluation

  10 years

Study Arms (4)

Physica KR

OTHER

Subjects that receive the Physica Kinematic Retaining Knee System

Device: Physica Kinematic Retaining Knee System

Physica CR

OTHER

Subjects that receive the Physica Cruciate Retaining Knee System

Device: Physica Cruciate Retaining Knee System

Physica PS

OTHER

Subjects that receive the Physica Posterior Stabilized Knee System

Device: Physica Posterior Stabilized Knee System

Physica CR with LMC Liner

OTHER

Subjects that receive the Physica Cruciate Retaining Knee System with LMC Liner

Device: Physica Cruciate Retaining Knee System with LMC Liner

Interventions

Physica Kinematic Retaining Knee System DEVICE

Modular total knee prosthesis with a Kinematic Retaining mechanism and posterior cruciate ligament (PCL) preservation

Physica KR

Physica Cruciate Retaining Knee System DEVICE

Total knee prosthesis with posterior cruciate ligament (PCL) preservation

Physica CR

Physica Posterior Stabilized Knee System DEVICE

Total knee prosthesis that sacrifices the posterior cruciate ligament (PCL) and replaces the functionality of the PCL with a post-cam mechanism.

Physica PS

Physica Cruciate Retaining Knee System with LMC Liner DEVICE

Total knee prosthesis with posterior cruciate ligament (PCL) preservation

Physica CR with LMC Liner

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Age\> 22 (skeletally mature)
• 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
• Suitable candidates for TKR who have undamaged and functional collateral ligaments
• 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
• 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
• Patients who have signed the Ethics Committee/IRB approved study-specific Informed Consent Form prior to the surgery

You may not qualify if:

• Patients with severe instability of the knee joint secondary to the absence of collateral ligament integrity and/or function
• Patients with active or any suspected infection (on the affected knee or systemic)
• Previous partial knee replacement (unicompartimental, bicompartimental or patellofemoral joint replacement), patellectomy, high tibial osteotomy
• Patients with significant bone loss on femoral or tibial joint side
• Current treatment for malignant and/or life-threatening non-malignant disorders
• Patients with known incompatibility or allergy to the product materials, and/or metal hypersensitivity to implant materials
• Vascular insufficiency of lower limbs severe enough to interfere with the study evaluation
• Patients with bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation to the prosthesis
• Patients with systemic or metabolic disorders leading to progressive bone deterioration which may impair fixation and stability of the implant
• Any concomitant disease and dependence that might affect the performance of the implanted prosthesis
• 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)
• Patients who have significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery and evaluation
• Patients who have neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device
• Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint
• Any psychiatric illness that would prevent comprehension of the details and nature of the study

Sponsors & Collaborators

• Limacorporate S.p.a: lead

Study Sites (5)

Eisenhower Desert Orthopedics Center - Harry and Diane Rinker Bldg

Rancho Mirage, California, 92270, United States

RECRUITING

The Orthopedics Clinic

Daytona Beach, Florida, 32117, United States

RECRUITING

Rush Castle Orthopaedics

Aurora, Illinois, 60504, United States

RECRUITING

Syracuse Orthopedic Specialists

Syracuse, New York, 13214, United States

COMPLETED

Joint Reconstructive Specialist

Oklahoma City, Oklahoma, 73159, United States

COMPLETED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteonecrosis; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Fabiana Pavan

  Limacorporate S.p.a

  STUDY DIRECTOR

Central Study Contacts

Fabiana Pavan

CONTACT

+390432945357; Fabiana.Pavan@limacorporate.com

Federica Azzimonti

CONTACT

federica.azzimonti@limacorporate.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 9, 2017
• Study Start: March 24, 2017
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)