A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System

restor3d

Status: Terminated

Conditions: Osteoarthritis of the Knee

Treatments: Device: iTotal G2 CR Knee Replacement System

Study type: Observational

Funder types: Industry

Identifiers

NCT01820650

12-001

Details and patient eligibility

About

This study is designed to observe the long term clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis.

Full description

If the patient has previously received a standard total knee replacement in their contralateral knee, the primary endpoint questionnaire and some secondary endpoint questionnaires will be completed regarding BOTH their iTotal® CR knee and their standard total knee for all time points where questionnaires are required by the protocol.

Enrollment: 359 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® CR
• 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

Exclusion criteria

• Simultaneous bilateral procedure required
• BMI > 40
• Active malignancy (defined as a history of any invasive malignancy - except non-melanoma skin cancer), unless patient 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
• Neuromuscular conditions which prevent patient from participating in study activities
• Active local or systemic infection
• Immunocompromised
• Fibromyalgia or other general body pain related condition
• 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 to an extent that the procedure is unjustified
• Diagnosed with or receiving treatment for Osteoporosis
• Other physical disability affecting the hips, spine, or contralateral knee.
• 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 > 15 º
• Fixed flexion contracture ≥ 15 º
• Unwilling or unable to comply with study requirements
• Participation in another clinical study which would confound results
• Allergy to any of the implant materials