OsteoarthritisRheumatoid ArthritisTraumatic ArthritisPost Traumatic DeformityComplications; ArthroplastyDeformity of Limb
Investigational drug(s) / intervention(s)
Vanguard SSK 360 with PS BearingVanguard SSK 360 with PSC bearingVanguard DA 360Vanguard 360 TiNbN Femur with PS bearingVanguard 360 TiNbN Femur with PSC bearing
Vanguard SSK 360 with PS Bearing: non-constrained tibial bearing
Vanguard SSK 360 with PSC bearing: constrained tibial bearing
Vanguard DA 360: Dual-articulation device, only cleared in EU
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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 exclusion criteria: patients who have a history of or current infection in the affected knee.
Primary outcome measure(s)
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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