This study evaluates the efficacy and safety of Hybrid Vanguard™ CR Deep Dish Rotating
Platform Knee by comparing it with Hybrid PFC Sigma CR Rotating Platform Knee.
Inclusion Criteria:
- Patients with a pre-operative Knee Score of <70
- Patients with one of the following primary diagnoses: Osteoarthritis, Traumatic
arthritis, Rheumatoid arthritis
- Patients who are at least 21 years of age
- Patients with intact and stable collateral ligaments
- Patients who have failed to respond to previous treatment modalities, such as, a trial
of analgesics, non-steroidal anti-inflammatories, physical therapy, arthroscopy, and
activity modification to be included in the study
- Patients with a likelihood of obtaining relief of pain and improved function
- Patients who are able to follow post operative care instructions
- Patients who are willing and able to return for scheduled follow-up evaluations
- Patients of all races and genders are eligible for enrollment
- Patients in which anatomic alignment can be achieved
- Patients who have signed the Ethic Committee approved Informed Consent Form
Exclusion Criteria:
- Patients with a pre-operative Knee Society Score of >= 70
- Patients who had previous prosthetic knee replacement device in the operative knee,
including unicondylar knee arthroplasty
- Patients who are less than 21 years of age
- Patients who are morbidly obese as defined by body mass index >= 40
- Patients with fixed flexion deformity >90
- Patients who have rapid joint destruction, marked bone loss, or bone resorption
apparent on roentgenogram
- Patients with a fused knee on operative side
- Patients who have active or suspected infection, local or systemic
- Patients with pre-existing condition(s) that may interfere with the survival of the
implants or their outcomes, including: Sickle Cell Anemia, Lower extremity muscular
atrophy, Neuromuscular disease, Vascular insufficiency, Metabolic Disorders which
impair bone formation (Paget's Disease, Osteomalacia, Severe Osteoporosis)
- Patients with clinical conditions that may limit follow-up, including:
Immuno-compromised conditions (i. e. HIV), Hepatitis, Active tuberculosis, Neoplastic
disease such as cancer of the prostate, lung, stomach, cervix, etc., Chronic renal
failure, Organ transplant (i. e. heart, liver, lung, etc.) recipients, Known terminal
disease process (i. e. multiple sclerosis, leukemia, lymphoma, etc.)
- Patients diagnosed with Parkinson's or Alzheimer's Disease
- Instability or deformity of the ligaments and/or surrounding soft tissue, which would
preclude stability of the prostheses
- Patients with a known metal allergy
- Prisoners, known drug or alcohol abusers, or mentally incompetent individuals
- Systemic steroids within the past 6 months or steroid injection into the affected knee
within the previous 3 months prior to enrollment
- Patients who are pregnant
- Severe valgus or varus knees (valgus or varus angulation of more than 20 degrees)
where collateral ligament, iliotibial band, or popliteal release is required
- Revision surgery on operative knee
- Patients who have not signed the IRB approved Informed Consent Form
