Data Collection Made Easy
- Until now, many physicians have been unable to participate in research related to their patient outcomes because of a lack of resources. The coflexCOMMUNITY study offers a unique opportunity to collect outcomes in an intuitive electronic database without the typical burden on your office and staff.
- SPIRITT Research will partner with you to take advantage of state-of-the-art data collection tools and technology, and will provide real-time assistance to your staff and your patients to ensure successful participation.
- Your participation in the coflexCOMMUNITY study will provide you with valuable insights into the outcomes of your coflex patients as well as access to aggregated data reports for patients across the country.
Patient Eligibility
Study Population
Cohort will be selected from clinic patients scheduled for surgery with coflex device after decompression.
Inclusion Criteria
Patient is skeletally mature and has at least moderate impairment in function, experiences relief in flexion from his/her symptoms of leg/buttocks/groin pain, with or without back pain, and has undergone at least 6 months of non-operative treatment.
Patient is treated surgically at 1 or 2 contiguous lumbar motion segments with the coflex Interlaminar Device from L1-L5 after decompression of stenosis at the affected level(s), where such use is not contraindicated as noted below.
Exclusion Criteria
- Prior fusion or decompressive laminectomy at any index lumbar level;
- Radiographically compromised vertebral bodies at any lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture);
- Severe facet hypertrophy that requires extensive bone removal which would cause instability;
- Grade II or greater spondylolisthesis;
- Isthmic spondylolisthesis or spondylolysis (pars fracture);
- Degenerative lumbar scoliosis (Cobb angle of greater than 25°);
- Osteoporosis;
- Back or leg pain of unknown etiology;
- Axial back pain only, with no leg, buttock, or groin pain;
- Morbid obesity defined as a body mass index > 40;
- Active or chronic infection – systemic or local;
- Known allergy to titanium alloys or magnetic resonance imaging (MRI) contrast agents;
- Cauda equina syndrome defined as neural compression causing neurogenic bowel or bladder dysfunction;
- Vulnerable population including pregnant women, prisoners, students and employees of treating physicians, and others who can be subject to coercion;
- Patient is unwilling to complete his/her surveys.
Primary Outcome Measures
- Improvement in the Oswestry Disability Index (ODI), compared to pre-surgery
- Patient has not undergone any reoperations, removals, revisions, or supplemental fixations;
- Patient has not had any major device related complications
- Patient has not undergone any Epidural injections
Secondary Outcome Measures
- Zurich Claudication Questionnaire (ZCQ)
- Quality of Life as measured by the Health Outcomes Survey and EQ-5D-5L
- VAS Back and Leg Pain
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
Interested in participating in the study?
Email us at: coflexCOMMUNITY@spirittresearch.com