Clinical Trial Finder

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)