A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

Rheumatoid Arthritis Clinical Trial

Official title:

A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01542580
• Other study ID #: GBMET.CR.G1
• Status: Recruiting
• Start date: March 2012
• Est. completion date: December 2031

Study information

• Verified date: February 2024
• Source: Zimmer Biomet
• Contact: Islem Guenaoui, PhD
• Phone: +33681294392
• Email: islem.guenaoui[@]zimmerbiomet.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 255
• Est. completion date: December 2031
• Est. primary completion date: December 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Complications; Arthroplasty
• Congenital Abnormalities
• Deformity of Limb
• Osteoarthritis
• Post Traumatic Deformity
• Rheumatoid Arthritis
• Traumatic Arthritis

Intervention

Device:
• Vanguard SSK 360 with PS Bearing
non-constrained tibial bearing
• Vanguard SSK 360 with PSC bearing
constrained tibial bearing
• Vanguard DA 360
Dual-articulation device, only cleared in EU
• Vanguard 360 TiNbN Femur with PS bearing
non-constrained tibial bearing, titanium niobium nitride coated Vanguard 360 femur
• Vanguard 360 TiNbN Femur with PSC bearing
constrained tibial bearing, titanium niobium nitride coated Vanguard 360 femur

Locations

Country	Name	City	State
Belgium	University Hopital Pellenberg	Pellenberg
Denmark	Aarhus university hospital	Aarhus
France	Ch Lyon Sud	Lyon
Germany	Klinik fur Endoprothetik und gelenkchirurgie	Bad Wildbad
Italy	IRCCS Istituto Ortopedico Galeazzi	Milano
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Spain	University Hospital Mutua de Terrasa	Terrassa
United Kingdom	Royal Orthopaedic Hospital	Birmingham
United States	Orthopedic Institute of Henderson	Henderson	Nevada
United States	Illinois Bone and Joint	Morton Grove	Illinois
United States	OrthoVirginia West End Orthopedic Clinic	Richmond	Virginia
United States	University of Utah Orthopedic Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AMERICAN KNEE SOCIETY KNEE SCORE	Improvement of American Knee Society Knee Score between pre-operative and 2 years post-operative follow up	24 months postoperative
Secondary	Survivorship	Survivorship at 10 years post-operative follow up	10 years postoperative