A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01542580
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Zimmer Biomet
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Russell Schenk, PhD
Principal Investigator Affiliation Zimmer Biomet
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Enrolling by invitation
Countries Belgium, Denmark, France, Germany, Italy, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Post Traumatic Deformity, Complications; Arthroplasty, Deformity of Limb
Additional Details

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.

Arms & Interventions

Arms

: Vanguard SSK 360 with PS Bearing

Patients enrolled using a Vanguard SSK 360 Posterior-Stabilized (non-constrained) tibial bearing.

: Vanguard SSK 360 with PSC Bearing

Patients enrolled using a Vanguard SSK 360 Posterior-Stabilized Constrained tibial bearing.

: Vanguard DA 360

Patients enrolled using a Vanguard DA 360 component.

: Vanguard 360 TiNbN Femur with PS Bearing

The Vanguard 360 TiNbN is the same system and functions in the same manner as the non-coated device.

: Vanguard 360 TiNbN Femur with PSC Bearing

The Vanguard 360 TiNbN is the same system and functions in the same manner as the non-coated device.

Interventions

Device: - Vanguard SSK 360 with PS Bearing

non-constrained tibial bearing

Device: - Vanguard SSK 360 with PSC bearing

constrained tibial bearing

Device: - Vanguard DA 360

Dual-articulation device, only cleared in EU

Device: - Vanguard 360 TiNbN Femur with PS bearing

non-constrained tibial bearing, titanium niobium nitride coated Vanguard 360 femur

Device: - Vanguard 360 TiNbN Femur with PSC bearing

constrained tibial bearing, titanium niobium nitride coated Vanguard 360 femur

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Illinois Bone and Joint, Morton Grove, Illinois

Status

Address

Illinois Bone and Joint

Morton Grove, Illinois, 60053

Orthopedic Institute of Henderson, Henderson, Nevada

Status

Address

Orthopedic Institute of Henderson

Henderson, Nevada, 89052

University of Utah Orthopedic Center, Salt Lake City, Utah

Status

Address

University of Utah Orthopedic Center

Salt Lake City, Utah, 84108

OrthoVirginia West End Orthopedic Clinic, Richmond, Virginia

Status

Address

OrthoVirginia West End Orthopedic Clinic

Richmond, Virginia, 23235

International Sites

University Hopital Pellenberg, Pellenberg, Belgium

Status

Address

University Hopital Pellenberg

Pellenberg, ,

Aarhus university hospital, Aarhus, Denmark

Status

Address

Aarhus university hospital

Aarhus, ,

Ch Lyon Sud, Lyon, France

Status

Address

Ch Lyon Sud

Lyon, , 69000

Bad Wildbad, Germany

Status

Address

Klinik fur Endoprothetik und gelenkchirurgie

Bad Wildbad, ,

IRCCS Istituto Ortopedico Galeazzi, Milano, Italy

Status

Address

IRCCS Istituto Ortopedico Galeazzi

Milano, ,

Azienda Ospedaliero Universitaria Pisana, Pisa, Italy

Status

Address

Azienda Ospedaliero Universitaria Pisana

Pisa, ,

University Hospital Mutua de Terrasa, Terrassa, Spain

Status

Address

University Hospital Mutua de Terrasa

Terrassa, ,

Royal Orthopaedic Hospital, Birmingham, United Kingdom

Status

Address

Royal Orthopaedic Hospital

Birmingham, , B31 2AP