Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee
A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

NCT01542580

Active Not RecruitingN/A

Sponsor: Zimmer Biomet

Conditions: Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Post Traumatic Deformity, Complications; Arthroplasty

Interventions: Vanguard SSK 360 with PS Bearing, Vanguard SSK 360 with PSC bearing, Vanguard DA 360, Vanguard 360 TiNbN Femur with PS bearing, Vanguard 360 TiNbN Femur with PSC bearing

Countries: United States, Belgium, Denmark, France, Germany, Italy, Spain, United Kingdom

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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.
Locations (12)
  • Morton Grove, Illinois, United States
  • Henderson, Nevada, United States
  • Salt Lake City, Utah, United States
  • Richmond, Virginia, United States
  • Pellenberg, Belgium
  • Aarhus, Denmark
  • Lyon, France
  • Bad Wildbad, Germany
  • Milan, Italy
  • Pisa, Italy
  • Terrassa, Spain
  • Birmingham, United Kingdom