Status:Not yet recruiting
Keywords:Revision , Outcomes , Biomet Vangaurd , Total Knee Arthroplasty , TKA
The purpose of this study is to evaluate the performance of the Vanguard® SSK 360 revision knee utilizing offset on either the tibial component, femoral component, or both in terms of the restoration of mechanical alignment, clinical outcomes and survivorship.
Principle Investigator: Chris Pelt
Principle Department: Orthopedic Surgery
Inclusion Criteria are identical to the indications for use stated in the FDA cleared labeling for the device in 510(k) K093293. These indications are stated below:
A. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, where one or more compartments are involved;
B. Correction of varus, valgus or posttraumatic deformity;
C. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of a previous total joint replacement procedure.
Patient selection factors to be considered include:
A. Need to obtain pain relief and improve function,
B. Ability and willingness of the patient to follow instructions, including control of weight and activity level,
C. A good nutritional state of the patient, and
D. The patient must have reached full skeletal maturity.
The Regenerex femoral augments are indicated for use with the Vanguard Total Knee System. The Regenerex tibial augments are indicated for use with standard and offset Biomet Tibial Trays. Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok) devices and all-polyethylene patellar components are indicated for cemented application only. Regenerex components are intended only for uncemented biologic fixation application.
Exclusion Criteria are identical to the contraindications for use stated in the FDA cleared labeling for the device in 510(k) K093293. These contraindications are stated below:
Absolute contraindications include: infection, sepsis, and osteomyelitis.
Relative contraindications include:
A. An uncooperative patient or a patient with neurologic disorders who is incapable of following directions
C. Metabolic disorders which may impair bone formation
E. Distant foci of infections which may spread to the implant site
F. Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
G. Vascular insufficiency, muscular atrophy, neuromuscular disease
H. Incomplete or deficient soft tissue surrounding the knee.
Biomet Microplasty Tibial Trays are contraindicated for use with constrained bearings. Additional research-related exclusion criteria: patients who have a history of or current infection in the affected knee.