Clinical Trials Logo

Clinical Trial Summary

The purpose of the data collection is to document the performance and clinical outcomes of the Vanguard Knee using Signature Custom Cutting Guides and Computer Assisted Surgery.


Clinical Trial Description

The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Vanguard® Knee System using Signature™ Custom Guides and Computer Assisted Surgery.

FDA has cleared the Vanguard Knee via premarket notification 510(k) K023546, K033489, and K050222. FDA has cleared the software for the Signature™ Custom Guides via premarket notification 510(k) K073449. The data gathered will be collated and used to provide feedback to design engineers, support marketing efforts, answer potential questions from reimbursement agencies, and will serve as a part of Biomet's Post Market Surveillance System.

Function will be assessed through the Knee Society Score. Survivorship will be documented by asking the surgeon to document revisions and complications. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01256216
Study type Interventional
Source Zimmer Biomet
Contact
Status Completed
Phase N/A
Start date September 2010
Completion date May 2016

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02314702 - Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems
Completed NCT03272139 - Interscalene Block Versus Superior Trunk Block Phase 4
Completed NCT03271151 - Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty Phase 4
Completed NCT01407874 - A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency Phase 2
Completed NCT03337243 - Effect of Implanting Allogenic Cytokines Derived From Human Amniotic Membrane (HAM) and Mesenchymal Stem Cells Derived From Human Umbilical Cord Wharton's Jelly (HUMCWJ) on Pain and Functioning of Knee Osteoarthritis N/A
Active, not recruiting NCT03294408 - Multimodal Imaging of Subchondral Bone in Knee Osteoarthritis : Predictive Model N/A
Withdrawn NCT02668211 - Radiostereometric Analysis (RSA) of the PROFEMUR® Preserve Classic Femoral Components N/A
Active, not recruiting NCT02239783 - Post Market Clinical Follow-Up Study Protocol for PROFEMUR® TL Modular Femoral Stems
Terminated NCT00698347 - A Clinical Investigation of the M2a-Magnum™ Hip System N/A
Completed NCT00223353 - Quantitative Gait Analysis for Clinical Decision Making N/A
Recruiting NCT04037735 - RSA-RCT: Attune S+ TKA Versus Sigma TKA N/A
Terminated NCT03575975 - 3D X-ray Motion Analysis of Ankle-foot Motion After Total Ankle Arthroplasty
Completed NCT03894514 - Multi-variable Prediction Model of Total Knee Replacement Outcome
Completed NCT02865447 - Evaluation of Bone Mineral Density Changes After Total Hip Replacement: A Two-Year Clinical and DXA Analysis
Enrolling by invitation NCT03576573 - Post Market Clinical Follow-Up Study Protocol for PROCOTYL® C Acetabular Components
Completed NCT02967874 - Autologous Adipose-Derived Stromal Vascular Fraction Cells for Osteoarthritis Treatment Phase 1/Phase 2
Completed NCT02390336 - Mobilization With Movement in Patients With Osteoarthritis of the Hip N/A
Terminated NCT03293719 - Post-market Follow up Study of the 'BPK-S Integration' UC as Primary Implant in the Variants CoCr or Ceramic
Active, not recruiting NCT02823834 - PMCF Study Protocol for PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components
Active, not recruiting NCT02351414 - Post Market Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts