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NCT01542580 | RECRUITING | Osteoarthritis

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

Zimmer Biomet

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.

Condition or disease

Osteoarthritis

Rheumatoid Arthritis

Traumatic Arthritis

Post Traumatic Deformity

Complications; Arthroplasty

Deformity of Limb

Intervention/treatment

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

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 255 participants
Official Title : A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee
Actual Study Start Date : 2012-03
Estimated Primary Completion Date : 2031-12
Estimated Study Completion Date : 2031-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

Location Details

NCT01542580

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, Illinois

Illinois Bone and Joint

Morton Grove, Illinois, United States, 60053

ENROLLING BY INVITATION

United States, Nevada

Orthopedic Institute of Henderson

Henderson, Nevada, United States, 89052

ENROLLING BY INVITATION

United States, Utah

University of Utah Orthopedic Center

Salt Lake City, Utah, United States, 84108

ENROLLING BY INVITATION

United States, Virginia

OrthoVirginia West End Orthopedic Clinic

Richmond, Virginia, United States, 23235

ENROLLING BY INVITATION

Belgium,

University Hopital Pellenberg

Pellenberg, Belgium,

SUSPENDED

Denmark,

Aarhus university hospital

Aarhus, Denmark,

TERMINATED

France,

Ch Lyon Sud

Lyon, France, 69000

TERMINATED

Germany,

Clinic for endoprosthetics and joint surgery

Bad Wildbad, Germany,

RECRUITING

Italy,

IRCCS Galeazzi Orthopedic Institute

Milano, Italy,

RECRUITING

Italy,

Pisan University Hospital

Pisa, Italy,

ENROLLING BY INVITATION

Spain,

University Hospital Mutua de Terrassa

terrace, Spain,

COMPLETED

United Kingdom,

Royal Orthopaedic Hospital

Birmingham, United Kingdom, B31 2AP