Vanguard XP Early Clinical Evaluation Protocol
|Principal Investigator: JeremyGililland|
|Keywords: Total Hip Replacement (THA) , Joint Replacement , Hip Revision||Department: Orthopedic Surgery|
|IRB Number: 00066089||Co Investigator: ChristopherPeters|
|Specialty: Joint Replacement, Joint Replacement|
|Sub Specialties: Knee Replacement|
Will assess all patients who present with a need for joint replacement arthroplasty to determine whether disease state is indicated for partial, Bicruciate retaining, or total knee replacement. These patients will be treated according to surgeon preference at each center. Only minimal information on this data set will be collected.
Patients who receive the cemented Vanguard XP BiCruciate Knee System based on meeting indications for use, and inclusion / exclusion criteria described in the protocol.
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis or 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 a previous joint replacement procedure.
The FDA has cleared the following components as indicated, but for purposes of this study we will only include cemented component fixation to limit variables:
- 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 for uncemented biologic fixation application.
Group B Exclusions:
Contraindicated for use in individuals with:
Relative contraindications include:
1. Uncooperative patients or patient with neurologic disorders who is incapable of following directions
3. Metabolic Disorders which may impair bone formation
5. Rapid joint destruction, marked bone loss or bone resportion apparent on roentgenram
Vascular insufficiency, muscular atrophy, neuromuscular disease
6. Incomplete or deficient soft tissue surrounding the knee