RECRUITING

Coflex PS3 Actual Conditions for Use Study

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Conditions

Spinal Stenosis Lumbarmoderate lumbar stenosisneurogenic claudicationspinal stenosislow back paindecompression

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A 2 and 5 year evaluation of clinical outcomes in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with additional stabilization using the coflex® Interlaminar Technology for FDA Actual Conditions of Use Study.

Official Title

A 2 and 5 Year Evaluation of Clinical Outcomes in the Treatment of Degenerative Spinal Stenosis With Concomitant Low Back Pain by Decompression With Additional Stabilization Using the Coflex® Interlaminar Technology for FDA Actual Conditions for Use Study.

Quick Facts

Study Start:2019-09-09
Study Completion:2027-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02555280

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Radiographic confirmation of at least moderate lumbar stenosis at one or two contiguous levels from L1-L5 that require surgical decompression.
  2. 2. Visual Analog Scale back pain score of at least 50 mm on a 100 mm scale.
  3. 3. Neurogenic claudication as defined by leg/buttocks or groin pain that can be relieved by flexion such as sitting in a chair.
  4. 4. Subject has undergone at least one lumbar injection at any prior time point, AND/OR at least 6 months of prior conservative care without adequate and sustained symptom relief.
  5. 5. Skeletally mature
  6. 6. Oswestry Low Back Pain Disability Questionnaire score of at least 20/50 (40%).
  7. 7. Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures.
  8. 8. Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the trial.
  1. 1. Prior fusion or decompressive laminectomy at index lumbar level.
  2. 2. Radiographically compromised vertebral bodies at any lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture).
  3. 3. Severe facet hypertrophy that requires extensive bone removal which would cause instability.
  4. 4. Isthmic spondylolisthesis or spondylolysis (pars fracture).
  5. 5. Degenerative lumbar scoliosis (Cobb angle of greater than 25°).
  6. 6. Osteoporsis or is at increased risk of osteoporosis.
  7. 7. Back or leg pain of unknown etiology.
  8. 8. Axial back pain only, with no leg, buttock, or groin pain.
  9. 9. Morbid obesity defined as a body mass index \> 40.
  10. 10. Known allergy to titanium, titanium alloys, or MR contrast agents.
  11. 11. Active or chronic infection - systemic or local.
  12. 12. Cauda equina syndrome, defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction.

Contacts and Locations

Study Contact

Laura Henderson
CONTACT
406-813-4107
lhenderson@xtantmedical.com
Isabella Rosales
CONTACT
406-924-5884
iroslaes@xtantmedical.com

Study Locations (Sites)

Desert Institute for Spine Care (DISC)
Phoenix, Arizona, 85020
United States
Hoag Orthopedics
Irvine, California, 92618
United States
Sutter Health
Sacramento, California, 95816
United States
Central Cost Neurological Surgery
San Luis Obispo, California, 93401
United States
Cervical Disc Center of Los Angeles
Santa Monica, California, 90404
United States
UC Health Spine Center
Aurora, Colorado, 80045
United States
Mercy Regional Medical Center
Durango, Colorado, 81301
United States
Tallahassee Neurological Clinic
Tallahassee, Florida, 32308
United States
01L_Northshore University Health System
Evanston, Illinois, 60201
United States
24_Unity Surgical Center, LLC
Lafayette, Indiana, 47905
United States
Orthopaedic Specialist of Northwest Indiana
Munster, Indiana, 46321
United States
Spine Institute of Louisiana
Shreveport, Louisiana, 71101
United States
St. Joseph's Medical Center
Wayne, New Jersey, 07470
United States
Northwell Health Physician Partners Orthopaedic Institute at Great Neck
Great Neck, New York, 11021
United States
Consulting Orthopaedic Associates
Toledo, Ohio, 43617
United States
Southern Oregon Orthpaedics
Medford, Oregon, 97504
United States
Summit Spine
Portland, Oregon, 97225
United States
03L_Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
Austin Neurosurgeons
Austin, Texas, 78746
United States

Collaborators and Investigators

Sponsor: Xtant Medical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-09
Study Completion Date2027-11

Study Record Updates

Study Start Date2019-09-09
Study Completion Date2027-11

Terms related to this study

Keywords Provided by Researchers

  • moderate lumbar stenosis
  • neurogenic claudication
  • spinal stenosis
  • low back pain
  • decompression

Additional Relevant MeSH Terms

  • Spinal Stenosis Lumbar