Custom knee implants put to the test against standard ones

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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