Coflex PS3 Actual Conditions for Use Study

Last updated: January 4, 2024
Sponsor: Xtant Medical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spondylolisthesis

Spinal Stenosis

Treatment

Decompression

coflex® Interlaminar Technology

Clinical Study ID

NCT02555280
PS3/P110008
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Radiographic confirmation of at least moderate lumbar stenosis at one or twocontiguous levels from L1-L5 that require surgical decompression.
  2. Visual Analog Scale back pain score of at least 50 mm on a 100 mm scale.
  3. Neurogenic claudication as defined by leg/buttocks or groin pain that can be relievedby flexion such as sitting in a chair.
  4. Subject has undergone at least one lumbar injection at any prior time point, AND/OR atleast 6 months of prior conservative care without adequate and sustained symptomrelief.
  5. Skeletally mature
  6. Oswestry Low Back Pain Disability Questionnaire score of at least 20/50 (40%).
  7. Psychosocially, mentally, and physically able to fully comply with this protocol,including adhering to scheduled visits, treatment plan, completing forms, and otherstudy procedures.
  8. Personally signed and dated informed consent document prior to any study-relatedprocedures indicating that the patient has been informed of all pertinent aspects ofthe trial.

Exclusion

Exclusion Criteria:

  1. Prior fusion or decompressive laminectomy at index lumbar level.
  2. Radiographically compromised vertebral bodies at any lumbar level(s) caused by currentor past trauma or tumor (e.g., compression fracture).
  3. Severe facet hypertrophy that requires extensive bone removal which would causeinstability.
  4. Isthmic spondylolisthesis or spondylolysis (pars fracture).
  5. Degenerative lumbar scoliosis (Cobb angle of greater than 25°).
  6. Osteoporsis or is at increased risk of osteoporosis.
  7. Back or leg pain of unknown etiology.
  8. Axial back pain only, with no leg, buttock, or groin pain.
  9. Morbid obesity defined as a body mass index > 40.
  10. Known allergy to titanium, titanium alloys, or MR contrast agents.
  11. Active or chronic infection - systemic or local.
  12. Cauda equina syndrome, defined as neural compression causing neurogenic bowel (rectalincontinence) or bladder (bladder retention or incontinence) dysfunction.

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Decompression
Phase:
Study Start date:
September 09, 2019
Estimated Completion Date:
November 30, 2027

Study Description

A prospective, multi center, concurrently enrolled, propensity score controlled through Month 60. The purpose is to fully characterize safety and efficacy then the coflex device is used in the intended subject population under actual conditions of use.

Connect with a study center

  • Desert Institute for Spinal Care (DISC)

    Phoenix, Arizona 85020
    United States

    Active - Recruiting

  • Desert Institute for Spine Care (DISC)

    Phoenix, Arizona 85020
    United States

    Active - Recruiting

  • Center for Neurosciences

    Tucson, Arizona 85718
    United States

    Site Not Available

  • Todd H. Lanman, M.D., Inc.

    Beverly Hills, California 90210
    United States

    Site Not Available

  • Hoag Orthopedics

    Irvine, California 92618
    United States

    Site Not Available

  • Beverly Hills Spine Surgery, Inc.

    Los Angeles, California 90048
    United States

    Site Not Available

  • Sutter Health

    Sacramento, California 95816
    United States

    Active - Recruiting

  • Central Cost Neurological Surgery

    San Luis Obispo, California 93401
    United States

    Active - Recruiting

  • Cervical Disc Center of Los Angeles

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • UC Health Spine Center

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • 20_Spine Colorado, PC

    Durango, Colorado 81301
    United States

    Active - Recruiting

  • Mercy Regional Medical Center

    Durango, Colorado 81301
    United States

    Site Not Available

  • 21_Center for Spine & Orthopedics

    Thornton, Colorado 80229
    United States

    Site Not Available

  • Tallahassee Neurological Clinic

    Tallahassee, Florida 32308
    United States

    Terminated

  • 01L_Northshore University Health System

    Evanston, Illinois 60201
    United States

    Completed

  • 24_Unity Surgical Center, LLC

    Lafayette, Indiana 47905
    United States

    Terminated

  • 25_Orthopedic Specialist of Northwest Indiana

    Munster, Indiana 46321
    United States

    Active - Recruiting

  • Orthopaedic Specialist of Northwest Indiana

    Munster, Indiana 46321
    United States

    Site Not Available

  • 01_Spine Institute of Louisiana

    Shreveport, Louisiana 71101
    United States

    Terminated

  • Spine Institute of Louisiana

    Shreveport, Louisiana 71101
    United States

    Terminated

  • 26_St. Joseph's University Medical Center

    Paterson, New Jersey 07503
    United States

    Site Not Available

  • St. Joseph's Medical Center

    Wayne, New Jersey 07470
    United States

    Site Not Available

  • 23_University Orthopaedic Associates at Great Neck

    Great Neck, New York 11021
    United States

    Active - Recruiting

  • Northwell Health Physician Partners Orthopaedic Institute at Great Neck

    Great Neck, New York 11021
    United States

    Active - Recruiting

  • Consulting Orthopaedic Associates

    Toledo, Ohio 43617
    United States

    Site Not Available

  • Southern Oregon Orthpaedics

    Medford, Oregon 97504
    United States

    Active - Recruiting

  • Summit Spine

    Portland, Oregon 97225
    United States

    Active - Recruiting

  • 03L_Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Terminated

  • 22_Austin Brain & Spine

    Austin, Texas 78746
    United States

    Active - Recruiting

  • Austin Neurosurgeons

    Austin, Texas 78746
    United States

    Active - Recruiting

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