Joint Disease
Conditions
Keywords
Arthritis, Osteoarthritis, Arthroplasty
Brief summary
The purpose of the data collection is to document the performance and clinical outcomes of the Vanguard Knee using Signature Custom Cutting Guides and Computer Assisted Surgery.
Detailed description
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Vanguard® Knee System using Signature™ Custom Guides and Computer Assisted Surgery. FDA has cleared the Vanguard Knee via premarket notification 510(k) K023546, K033489, and K050222. FDA has cleared the software for the Signature™ Custom Guides via premarket notification 510(k) K073449. The data gathered will be collated and used to provide feedback to design engineers, support marketing efforts, answer potential questions from reimbursement agencies, and will serve as a part of Biomet's Post Market Surveillance System. Function will be assessed through the Knee Society Score. Survivorship will be documented by asking the surgeon to document revisions and complications.
Interventions
DEVICETotal Knee Replacement with Vanguard Total Knee
Patients indicated for a total knee replacement utilizing the Vanguard Total Knee System.
Sponsors
Zimmer Biomet
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inclusion criteria are identical to the indications for use stated in the FDA cleared labeling for the device (510(k) K023546, K033489, and K050222). These indications are stated below: * Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. * Correction of varus, valgus, or posttraumatic deformity. * Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. * 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. Patient selection factors to be considered include: * Need to obtain pain relief and improve function * Ability and willingness of the patient to follow instructions, including control of weight and activity level * A good nutritional state of the patient, and * The patient must have reached full skeletal maturity * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical Alignment | Data Collected at 0-10 Weeks; but Analyzed at Completion of Study | Angle between femoral head, center of knee, and talus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Objective Score | Completion of Study | Objective Scoring of Knee Society score is the clinical assessment which includes the sum of range of motion, stability, flexion contracture, extension lag, and alignment scores. |
Countries
United Kingdom
Outcome results
None listed