A Study to Evaluate the Conformis iTotal Identity Knee Replacement System

NCT ID: NCT04667559

Last Updated: 2023-10-25

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-12
• Study Completion Date: 2022-12-14

Brief Summary

This is a prospective multicenter study located in the United States. Subjects will be implanted with an iTotal Identity Knee Replacement System and followed for 10 years post implantation.

Conditions

Osteoarthritis, Knee

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Conformis iTotal Identity Knee Replacement System

The iTotal® Identity KRS is a tri-compartmental semi-constrained knee prosthesis composed of three components: a Femoral Component, a Tibial Component, and a Patellar Component.Using patient imaging, a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The treatment allows for the placement of a cemented metallic device designed from the patient's natural bone geometry. This process allows definition of the shape and size of the femoral and tibial components of the implant, as well as the disposable instrumentation.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Clinical condition included in the approved Indications For Use for the iTotal Identity CR KRS
• Osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a TKR procedure. Disease status is assessed by Clinical and Radiographic assessment.
• Willingness to participate in the clinical study, to give informed consent, and to attend all follow-up visits
• > 18 years of age with complete development of musculoskeletal structures

Exclusion Criteria

• Simultaneous bilateral procedure required
• BMI > 40
• Active malignancy (defined as a history of any invasive malignancy - except nonmelanoma skin cancer), unless subject has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years
• Poorly controlled diabetes (defined as HbA1c >7 or Investigator discretion)
• Neuromuscular conditions which prevent subject from participating in study activities
• Active local or systemic infection which precludes TKR procedure
• Immunocompromised in the opinion of the Investigator
• Medically diagnosed fibromyalgia or similar conditions that might impact the subject's ability to differentiate source of pain
• Rheumatoid arthritis or other forms of inflammatory joint disease
• Loss of bone or musculature, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated on, to an extent that the procedure is unjustified
• Diagnosed with or receiving treatment for osteoporosis that is likely to confound results in the opinion of the Investigator
• Other physical disability affecting the hips, spine, or contralateral knee that is likely to confound results in the opinion of the Investigator
• Severe instability due to advanced loss of osteochondral structure
• Prior arthroplasty of the affected knee, including High Tibial Osteotomy (HTO)
• Compromised PCL or collateral ligament
• Severe fixed valgus or varus deformity of >15º
• Extensor lag > 15º
• Fixed flexion contracture ≥ 15º
• Unwilling or unable to comply with study requirements
• Participation in another clinical study which would confound results
• Allergy to any of the implant materials
• Pregnant or planning to become pregnant prior to study TKR procedure (in case of pregnancy after study TKR procedure, eligibility to continue with the protocol will be reviewed)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Restor3D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Personalized Orthopedic Research Institute

Boynton Beach, Florida, United States

Tennessee Orthopaedic Alliance

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

20-001

Identifier Type: -

Identifier Source: org_study_id