Study Purpose
- The coflex®COMMUNITY study is an observational study for real-conditions-of-use patients treated with the coflex device for lumbar spinal stenosis. This prospective, non-randomized study will be conducted by SPIRITT in conjunction with surgeons at centers across the United States who have an interest in research about their patients’ outcomes with coflex.
- Using validated questionnaires in a unique electronic format, SPIRITT will collect patient-reported outcomes preoperatively and at scheduled time points out to five years postoperatively. This study will also collect surgeon-reported data pre-operatively, intra-operatively, and at any post-operative office visits.
Patient Eligibility
Surgeons participating in the coflex®COMMUNITY study will determine the eligibility of their coflex patients based on the study protocol, and will offer eligible patients the opportunity to participate.
List of Participating Surgeons
Dr. Mohamed Abdulhamid
Arizona Brain & Spine Center
Dr. Thomas Guido Andreshak
Consulting Orthopaedic Associates
Dr. Hyun W. Bae
The Spine Institute, Center for Spinal Restoration
Dr. Steven M. Bailey
SIMED
Dr. Harvinder S. Bedi
AZ Integrated Neuro Spine & Pain
Dr. James B. Billys
The B.A.C.K. Center
Dr. Tuan L. Bui
OrthoAtlanta
Dr. Jeffrey B. Cantor
Cantor Spine Institute
Dr. R. Scott Cowan
New England Orthopedic Surgeons
Dr. Devin K. Datta
The B.A.C.K. Center
Dr. Stephen M. David
Blue Ridge Bone & Joint – EmergeOrtho
Dr. Reginald J. Davis
Laser Spine Institute
Dr. William A. Earman, Jr.
Palos Medical Group
Dr. Ira D. Fisch
OrthoBethesda
Dr. Matthew F. Gornet
The Orthopedic Center of St. Louis
Dr. James A. Guess
OrthoTexas
Dr. Mark J. Hornyak
Bassett Healthcare
Dr. Douglas B. Kasow
OrthoAtlanta
Dr. Mohammed F. Khan
North Jersey Brain & Spine Center
Dr. David K. Kim
OrthoNeuro
Dr. Reginald Q. Knight
Bassett Healthcare
Dr. Adam Lipson
IGEA Brain & Spine
Dr. Yi Lu
Brigham and Women’s Hospital
Dr. Michael MacMillan
SIMED
Dr. Brett G. Menmuir
Laser Spine Institute
Dr. Anil K. Nair
IGEA Brain & Spine
Dr. Omar N. Osmani
Spine & Orthopedic Center of New Mexico
Dr. Paul J. Pagano
All Florida Orthopaedics
Dr. John H. Peloza
Center for Spine Care
Dr. G. Jeffrey Poffenbarger
Bighorn Medical Center
Dr. David Poulad
IGEA Brain & Spine
Dr. Ciro G. Randazzo
IGEA Brain & Spine
Dr. David S. Raskas
Orthopedic & Spine Institute of St. Louis
Dr. Patrick A. Roth
North Jersey Brain & Spine Center
Dr. Thomas B. Scully
Northwest NeuroSpecialists
Dr. Larry Shannon
Bassett Healthcare
Dr. Carrie L. Shulman
Laser Spine Institute
Dr. Harshpal Singh
North Jersey Brain & Spine Center
Dr. D. Troy Trimble
The Orthopaedic Institute
Dr. Timothy A. VanFleet
Orthopedic Center of Illinois
Dr. Roy D. Vingan
North Jersey Brain & Spine Center
Dr. Michael C. Weiss
Laser Spine Institute
Dr. Richard N. W. Wohns
NeoSpine
Who We Are
PROOF
- The sponsor of the coflexCOMMUNITY study is Predicted, Reported, and Observed Outcomes Foundation (PROOF), a not-for-profit organization. The mission of PROOF is to advance the practice of medicine by supporting highly impactful clinical research studies and education that benefit clinicians, patients and other stakeholders who seek quality research evidence that improves the lives of patients.
SPIRITT
- SPIRITT Research is a patient-centric evidence development and specialty clinical research services organization. SPIRITT has been selected by PROOF to conduct the coflex®COMMUNITY study in partnership with participating surgeons throughout the United States.
- To learn more about SPIRITT, visit www.spirittresearch.com