Signature Versus Computer Assisted Surgery Study

Status Completed

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

Clinical Trial Details

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

View Details

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Withdrawn	`NCT02668211` - Radiostereometric Analysis (RSA) of the PROFEMUR® Preserve Classic Femoral Components	N/A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