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Lead
Restor3D
To compare functional and patient reported outcome data for a consecutively enrolled group of subjects who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system.The person conducting the functional testing will be blinded to the device implanted. Sites will perform the off-the-shelf total knees conventional instrumentation.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Inclusion:
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:
Subject will require a simultaneous bilateral procedure
Other lower extremity surgery within 1 year
Severe (\> 15º) fixed valgus or varus deformity
Severe (\> 15º) extension deficit
Severe instability due to advanced loss of osteochondral structure
Loss of bone or musculature, osteoporosis, neuromuscular or vascular compromise in the area of the joint to be operated on to an extent that the procedure is unjustified
Insufficient bone stock on the femoral or tibial surfaces
Contralateral knee replacement surgery within the past 6 months
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 (defined as HbA1c \>7 or surgeon discretion)
Immunocompromised
Other physical disability affecting the hips, spine, or contralateral knee that limits function
Disabling chronic pain with narcotic dependence
Compromised PCL or collateral ligament
Prior history of failed implant surgery of the joint to be treated, including Unicompartmental Knee Arthroplasty (UKA), or Bicompartmental Knee Arthroplasty (BKA)
Prior history of failed high tibial osteotomy (HTO)
Participation in another clinical study which would confound results
Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons
Clareo Health | A Multicenter Study to Evaluate Functional Outcome After Knee Replacement
