Nashville,
Tennessee
37203
Purpose:
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.
Criteria:
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)