A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

Recruiting

• Conditions: Rheumatoid Arthritis; Traumatic Arthritis; Deformity of Limb; Post Traumatic Deformity; Complications; Arthroplasty; Osteoarthritis
• Interventions: Device: Vanguard SSK 360 with PS Bearing; Device: Vanguard 360 TiNbN Femur with PSC bearing; Device: Vanguard 360 TiNbN Femur with PS bearing; Device: Vanguard SSK 360 with PSC bearing; Device: Vanguard DA 360

• Registration Number: NCT01542580
• Lead 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.

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 Timeline

• Study First Submitted: 2012-02-27
• Study First Submitted QC: 2012-02-27
• Study Start: 2012-03
• Study First Posted: 2012-03-02
• Status Verified: 2024-09
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-03-25
• Primary Completion: 2031-12
• Study Completion: 2031-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 255

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vanguard SSK 360 with PS Bearing	Vanguard SSK 360 with PS Bearing	Patients enrolled using a Vanguard SSK 360 Posterior-Stabilized (non-constrained) tibial bearing.
Vanguard 360 TiNbN Femur with PSC Bearing	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.
Vanguard 360 TiNbN Femur with PS Bearing	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 SSK 360 with PSC Bearing	Vanguard SSK 360 with PSC bearing	Patients enrolled using a Vanguard SSK 360 Posterior-Stabilized Constrained tibial bearing.
Vanguard DA 360	Vanguard DA 360	Patients enrolled using a Vanguard DA 360 component.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Survivorship	10 years postoperative	Survivorship at 10 years post-operative follow up

Trial Locations

Locations (12)

Illinois Bone and Joint; 🇺🇸 Morton Grove, Illinois, United States

Orthopedic Institute of Henderson; 🇺🇸 Henderson, Nevada, United States

University of Utah Orthopedic Center; 🇺🇸 Salt Lake City, Utah, United States

OrthoVirginia West End Orthopedic Clinic; 🇺🇸 Richmond, Virginia, United States

University Hopital Pellenberg; 🇧🇪 Pellenberg, Belgium

Aarhus university hospital; 🇩🇰 Aarhus, Denmark

Ch Lyon Sud; 🇫🇷 Lyon, France

Klinik fur Endoprothetik und gelenkchirurgie; 🇩🇪 Bad Wildbad, Germany

IRCCS Istituto Ortopedico Galeazzi; 🇮🇹 Milano, Italy

Azienda Ospedaliero Universitaria Pisana; 🇮🇹 Pisa, Italy

University Hospital Mutua de Terrasa; 🇪🇸 Terrassa, Spain

Royal Orthopaedic Hospital; 🇬🇧 Birmingham, United Kingdom