A Study to Evaluate the Conformis iTotal Identity Knee Replacement System

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Status: Terminated

Conditions: Osteoarthritis, Knee

Treatments: Device: Conformis iTotal Identity Knee Replacement System

Study type: Observational

Funder types: Industry

Identifiers

NCT04667559

20-001

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)