A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Illinois
Illinois Bone and Joint
ACTIVE_NOT_RECRUITING
Morton Grove
Nevada
Orthopedic Institute of Henderson
TERMINATED
Henderson
Utah
University of Utah Orthopedic Center
COMPLETED
Salt Lake City
Virginia
OrthoVirginia West End Orthopedic Clinic
ACTIVE_NOT_RECRUITING
Richmond
Other Locations
Belgium
University Hopital Pellenberg
ENROLLING_BY_INVITATION
Pellenberg
Denmark
Aarhus university hospital
SUSPENDED
Aarhus
France
Ch Lyon Sud
TERMINATED
Lyon
Germany
Klinik fur Endoprothetik und gelenkchirurgie
TERMINATED
Bad Wildbad
Italy
IRCCS Istituto Ortopedico Galeazzi
RECRUITING
Milan
Azienda Ospedaliero Universitaria Pisana
RECRUITING
Pisa
Spain
University Hospital Mutua de Terrasa
ACTIVE_NOT_RECRUITING
Terrassa
United Kingdom
Royal Orthopaedic Hospital
COMPLETED
Birmingham
Contact Information
Primary
Andrea Singer
andrea.singer@zimmerbiomet.com
Time Frame
Start Date: 2012-03
Estimated Completion Date: 2031-12
Participants
Target number of participants: 255
Treatments
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.
Sponsors
Leads: Zimmer Biomet

This content was sourced from clinicaltrials.gov