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.

coflex®  Device

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


Dr. Harvinder S. Bedi

AZ Integrated Neuro Spine & Pain

Dr. James B. Billys

The B.A.C.K. Center

Dr. Tuan L. Bui


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


Dr. Matthew F. Gornet

The Orthopedic Center of St. Louis

Dr. James A. Guess


Dr. Mark J. Hornyak

Bassett Healthcare

Dr. Douglas B. Kasow


Dr. Mohammed F. Khan

North Jersey Brain & Spine Center

Dr. David K. Kim


Dr. Reginald Q. Knight

Bassett Healthcare

Dr. Adam Lipson

IGEA Brain & Spine

Dr. Yi Lu

Brigham and Women’s Hospital

Dr. Michael MacMillan


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


Interested in participating in the study?

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