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Clinical Trials in the UK / NCT01542580
Active, not recruiting Observational

A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

NCT01542580 · tracked via the Priya Life Science UK tracker
Sponsor
Zimmer Biomet
Phase
Observational
Started
2012-03
Last updated
2025-11-25

Condition(s) studied

OsteoarthritisRheumatoid ArthritisTraumatic ArthritisPost Traumatic DeformityComplications; ArthroplastyDeformity of Limb

Investigational drug(s) / intervention(s)

Vanguard SSK 360 with PS BearingVanguard SSK 360 with PSC bearingVanguard DA 360Vanguard 360 TiNbN Femur with PS bearingVanguard 360 TiNbN Femur with PSC bearing

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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

Trial sites (12)

FacilityCityRegionStatus
Illinois Bone and Joint Morton Grove Illinois
Orthopedic Institute of Henderson Henderson Nevada
University of Utah Orthopedic Center Salt Lake City Utah
OrthoVirginia West End Orthopedic Clinic Richmond Virginia
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 Milan Italy
Azienda Ospedaliero Universitaria Pisana Pisa Italy
University Hospital Mutua de Terrasa Terrassa Spain
Royal Orthopaedic Hospital Birmingham United Kingdom

More Zimmer Biomet trials in the UK

Zimmer® Natural Nail® (ZNN) Bactiguard Tibia Post-Market Clinical Follow-up Study Recruiting
ZNN Bactiguard Retrograde Femoral Nails PMCF Study Recruiting
Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System Active, not recruiting
ZNN Bactiguard Antegrade Femoral Nails PMCF Study Recruiting
Clinical Outcomes Study of the Nexel Total Elbow Recruiting

Other trials for the same condition

Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis Active, not recruiting
Efficacy and Safety of Eloralintide (LY3841136) in Participants With Osteoarthritis Knee Pain and Obesity or Overweight Recruiting
A Study of Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis (RENOIR) Active, not recruiting
AMIStem Primary Hip System Prospective Post-marketing Multi-centre Surveillance Study Active, not recruiting
Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01542580 on ClinicalTrials.gov ↗ ← All trials in the UK