Complications; Arthroplasty, Deformity of Limb, Osteoarthritis, Post Traumatic Deformity, Rheumatoid Arthritis, Traumatic Arthritis
Conditions
Keywords
Revision surgery
Brief summary
The purpose of this study is to evaluate performance of the Vanguard 360 revision knee system utilizing offset on either the tibial component, femoral component, or both in terms of the restoration of mechanical alignment, clinical outcomes and survivorship.
Detailed description
This investigation is being conducted on a new complete revision knee system, Vanguard 360, which incorporates: * Fixed Bearing Knee - Vanguard SSK360 with PS Bearing and PSC Bearing * Fixed Bearing Knee - Vanguard SSK360 TiNbN Femur with PS Bearing and PSC Bearing * Mobile Bearing Knee - Vanguard DA360 (only being collected in Europe) The purpose of this study is to evaluate performance of the Vanguard 360 revision knee system utilizing offset on either the tibial component, femoral component, or both in terms of the restoration of mechanical alignment, clinical outcomes and survivorship. The efficacy and performance of the devices will be assessed by improvement of pain, function, range of motion and patient satisfaction measured pre-operatively and post-operatively. Secondary performance and safety will be determined by radiographic investigation, incidence of complications and revision rates. Surgical techniques and patient care are to be standard for the surgeon participating in the protocol. There will be no experimental or investigational devices used. There will be no experimental or investigational surgical techniques used. The devices and products will be used in accordance with their instructions for use and/or approved labeling.
Interventions
DEVICEVanguard SSK 360 with PS Bearing
non-constrained tibial bearing
DEVICEVanguard SSK 360 with PSC bearing
constrained tibial bearing
DEVICEVanguard DA 360
Dual-articulation device, only cleared in EU
DEVICEVanguard 360 TiNbN Femur with PS bearing
non-constrained tibial bearing, titanium niobium nitride coated Vanguard 360 femur
DEVICEVanguard 360 TiNbN Femur with PSC bearing
constrained tibial bearing, titanium niobium nitride coated Vanguard 360 femur
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. * Correction of varus, valgus or post-traumatic deformity * Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure * Ability and willingness of the patient to attend follow-up visit. * Willing to give written informed consent * Patients are at least 18 years of age, no upper age limit, must have reached full skeletal maturity.
Exclusion criteria
* infection * sepsis * osteomyelitis Relative Contraindications: * An uncooperative patient or a patient with neurologic disorders who is incapable of following directions * Osteoporosis * Metabolic disorders which may impair brain function * 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, neuromuscular disease * Incomplete or deficient soft tissue surrounding the knee Additional research-related
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AMERICAN KNEE SOCIETY KNEE SCORE | 24 months postoperative | Improvement of American Knee Society Knee Score between pre-operative and 2 years post-operative follow up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survivorship | 10 years postoperative | Survivorship at 10 years post-operative follow up |
Countries
Belgium, Denmark, France, Germany, Italy, Spain, United Kingdom, United States
Outcome results
None listed