Interbody Systems: Post Market Clinical Follow-up Study

Last updated: March 9, 2022
Sponsor: K2M, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04911257
CAS-017
  • Ages > 18
  • All Genders

Study Summary

This is a prospective, multi-center study of subjects who will undergo spinal fusion surgery utilizing Stryker Interbody Systems that require post market clinical follow up (PMCF).

The primary study hypothesis for each system is that the mean change in NDI (cervical) or ODI (lumbar) from baseline to Month 12 < -10, that is, the mean improvement exceeds 10 points. In supporting analysis, the same hypotheses will be tested for mean change from baseline to 24 months to demonstrate durability of effectiveness.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Must be planned to undergo spinal fusion surgery utilizing Stryker Interbody Systemsfor on label indications, which are listed below as inclusion criteria.
  2. Diagnosed with degenerative disc disease (DDD). Please note for Lumbar devices:
  • Can also be diagnosed with up to Grade 1 Spondylolisthesis and/or DegenerativeScoliosis. (Chesapeake is not indicated for degenerative scoliosis)
  • Cascadia/Mojave/ Sahara/ Monterey AL can also be diagnosed with up to Grade 1Retrolisthesis. Outside of USA, Tritanium is indicated for use in patients with diagnosis ofDegenerative Spine Disorders, Spine Revision, Discal and Vertebral Instability; andthere is no restriction to Spondylolisthesis Grade.
  1. Willingness and ability to comply with the requirements of the protocol includingfollow up requirements.
  2. Willing and able to sign a study specific informed consent form.
  3. Skeletally mature (age at least 18 years) and:
  4. Have had six months of lumbar non operative therapy.
  5. Have had six weeks of cervical non operative treatment.
  6. Will undergo interbody fusion at one or two contiguous levels (Chesapeake Cervical Tiis only indicated for use at one level) at:
  7. L2 L5 for Cascadia lateral hyperlordotic (>22°l).
  8. L2 S1 for all other lumbar interbody systems.
  9. C2 T1 for cervical interbody systems.
  10. Self reports Oswestry Disability Index (ODI) score 30% (raw score of 15/50) for lumbarpatients and Neck Disability Index (NDI) score 30% (raw score of 15/50) for cervicalpatients at pre operative visit.

Exclusion

Exclusion Criteria:

  1. Any condition where the implants interfere with anatomical structures or precludes thebenefit of spinal surgery.
  2. For the Tritanium and Monterey AL systems: Any neuromuscular deficit which places anunsafe load on the device during the healing period.
  3. For the Cascadia, Chesapeake, Mojave and Sahara systems: Metabolic disorders ofcalcified tissues.
  4. Biological factors such as smoking or using nonsteroidal anti inflammatory agents/anticoagulants.
  5. Immunosuppressive disorders.
  6. Grossly distorted anatomy. N/A for Tritanium TL, Tritanium Cervical and Monterey AL
  7. Inadequate tissue coverage or open wounds.
  8. Infection at index level(s) at the time of surgery.
  9. Patients with known sensitivity to materials in the device.
  10. Has a neuromuscular disorder or mental condition (including general neurologicalconditions, mental illness, senility, and drug/alcohol abuse) which would create anunacceptable risk of fixation failure or complications in postoperative care orwillingness to restrict activities or follow medical advice.
  11. Obesity.
  12. Other medical or surgical condition which would preclude the potential benefit ofspinal implant surgery, such as the presence of tumors, congenital abnormalities,elevation of sedimentation rate unexplained by other diseases, elevation of whiteblood cell count (WBC) or marked left shift in the WBC differential count.
  13. For the Tritanium and Monterey AL systems: Any abnormality which affects the normalprocess of bone remodeling including, but not limited to severe osteoporosis involvingthe spine, bone absorption, osteopenia, primary or metastatic tumors involving thespine or certain metabolic disorders affecting osteogenesis. Please note for Tritanium cervical this also includes rapid joint disease, boneabsorption, osteopenia, osteomalacia, and/or osteoporosis.
  14. For the Tritanium, Monterey AL, Chesapeake and Sahara systems: Prior fusion at thelevel to be treated (as indicated in the IFU).
  15. Pregnancy, or if the patient intends to become pregnant during the course of thestudy.
  16. Incarcerated at the time of study enrollment.
  17. Current participation in an investigational study that may impact study outcomes.
  18. Involved in current or pending litigation regarding a spine surgery.
  19. Receiving worker's compensation.

Study Design

Total Participants: 460
Study Start date:
December 07, 2021
Estimated Completion Date:
February 01, 2027

Connect with a study center

  • Spine Institute of Louisiana Foundation, Inc.

    Shreveport, Louisiana 71101
    United States

    Active - Recruiting

  • The Spine Clinic of Oklahoma City

    Oklahoma City, Oklahoma 73114
    United States

    Active - Recruiting

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