Vanguard™ Deep Dish Rotating Platform Knee Clinical Evaluation
Vanguard™ Deep Dish Rotating Platform Knee Clinical Evaluation
This study is being conducted on the Vanguard™ Deep Dish Rotating Platform (DD RP) to
 evaluate the clinical efficacy of the DDRP components.
This study is designed to evaluate the safety and efficacy of Vanguard™ Deep Dish Rotating
 Platform Knee (mobile bearing knee) as compared to Vanguard Cruciate Retaining Knee (fixed
 bearing knee). This trial will be conducted as the randomised, controlled study.

 Implant loosening and polyethylene wear in fixed-bearing knee prostheses were recognized as
 major causes of late failure. The mobile bearing knee have the theoretical advantages of
 potentially minimizing the polyethylene wear and reducing implant to bone interface stress in
 order to reduce the incidence of implant loosening. Therefore, the aims of this study are to
 prove the Vanguard deep dish rotating platform knee is at least as effective in clinical
 outcome as the widely used current design of knee replacement and better in long term
 survivorship.

 The efficacy of the device will be determined by the relief of pain, restoration of function
 and range of motion. The durability of device will be determined by the absence of
 revision/removal and radiological integrity. To assess the safety of the device, all post
 operative complications will be recorded either device related or otherwise. Patient
 satisfaction as determined by answers to patient outcome questionnaires (Oxford Knee Score,
 WOMAC and Lower Extremity Activity Scale).
Inclusion Criteria:

 -  Patients with a pre-operative knee score of < 70

 -  Patients scheduled to undergo primary total knee replacement with any of the following
 indication: Painful and disabled knee joint resulting from osteoarthritis, Traumatic
 Arthritis, Rheumatoid Arthritis; One or more compartments are involved

 -  Need to obtain pain relief and improve function

 -  Ability and willingness to follow instructions, including control of weight and
 activity level, and to return for follow-up evaluations

 -  A good nutritional state of the patient

 -  Full skeletal maturity of the patient, patients who are at least 18 years of age

 -  Patients of either sex

 -  Consent form read, understood, and signed by patient

 Exclusion Criteria:

 Absolute contraindications include the following diagnoses:

 -  Patients with a pre-operative knee score of >= 70

 -  Infection

 -  Osteomyelitis

 -  Previous partial or total prosthetic knee replacement on the operative side

 -  Patients who are less than 18 years of age

 -  Sepsis

 -  Patients who had body mass index >= 40

 Relative contraindications include the following factors:

 -  Uncooperative patient or patient with neurological disorders who are incapable of
 following directions or who are predictably unwilling to return for follow-up
 examinations

 -  Osteoporosis or marked bone loss, which may preclude proper fixation of the prosthesis

 -  Metabolic disorders, which may impair bone formation

 -  Osteomalacia

 -  Distant foci of infections, which may spread to the implant site

 -  Rapid joint destruction, marked bone loss, or bone resorption apparent on
 roentgenogram

 -  Vascular insufficiency, muscular atrophy, or neuromuscular disease in the affected
 limb.

 -  Incomplete or deficient soft tissue surrounding the knee