Clinical trial NCT04911257: Interbody Systems: Post Market Clinical Follow-up Study
Official title: Multi Center, Prospective Evaluation for Clinical and Radiographic Outcomes Utilizing Stryker Spine Cervical and Lumbar Interbody Systems: Observational Post Market Clinical Follow up Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Degenerative Disc Disease
Keywords: Spondylolisthesis
Degenerative Scoliosis
Retrolisthesis.
Lead sponsor: K2M, Inc.
Sponsor class: INDUSTRY
First posted: 2021-06-03
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study sample will include patients that present with on-label conditions that will be surgically treated by participating investigators.

Brief 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 Criteria:

1. Must be planned to undergo spinal fusion surgery utilizing Stryker Interbody Systems for 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 Degenerative Scoliosis. (Chesapeake is not indicated for degenerative scoliosis)
   * Cascadia/Mojave/ Sahara/ Monterey AL can also be diagnosed with up to Grade 1 Retrolisthesis.

   Outside of USA, Tritanium is indicated for use in patients with diagnosis of Degenerative Spine Disorders, Spine Revision, Discal and Vertebral Instability; and there is no restriction to Spondylolisthesis Grade.
3. Willingness and ability to comply with the requirements of the protocol including follow up requirements.
4. Willing and able to sign a study specific informed consent form.
5. Skeletally mature (age at least 18 years) and:

   1. Have had six months of lumbar non operative therapy.
   2. Have had six weeks of cervical non operative treatment.
6. Will undergo interbody fusion at one or two contiguous levels (Chesapeake Cervical Ti is only indicated for use at one level) at:

   1. L2 L5 for Cascadia lateral hyperlordotic (\>22°l).
   2. L2 S1 for all other lumbar interbody systems.
   3. C2 T1 for cervical interbody systems.
7. Self reports Oswestry Disability Index (ODI) score 30% (raw score of 15/50) for lumbar patients and Neck Disability Index (NDI) score 30% (raw score of 15/50) for cervical patients at pre operative visit.

Exclusion Criteria:

1. Any condition where the implants interfere with anatomical structures or precludes the benefit of spinal surgery.
2. For the Tritanium and Monterey AL systems: Any neuromuscular deficit which places an unsafe load on the device during the healing period.
3. For the Cascadia, Chesapeake, Mojave and Sahara systems: Metabolic disorders of calcified 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 neurological conditions, mental illness, senility, and drug/alcohol abuse) which would create an unacceptable risk of fixation failure or complications in postoperative care or willingness to restrict activities or follow medical advice.
11. Obesity.
12. Other medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors, congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood 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 normal process of bone remodeling including, but not limited to severe osteoporosis involving the spine, bone absorption, osteopenia, primary or metastatic tumors involving the spine or certain metabolic disorders affecting osteogenesis.

    Please note for Tritanium cervical this also includes rapid joint disease, bone absorption, osteopenia, osteomalacia, and/or osteoporosis.
14. For the Tritanium, Monterey AL, Chesapeake and Sahara systems: Prior fusion at the level to be treated (as indicated in the IFU).
15. Pregnancy, or if the patient intends to become pregnant during the course of the study.
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.

Primary outcomes:
measure: Mean Oswestry Disability Index Change
timeFrame: 12 Months
measure: Mean Neck Disability Index Change
timeFrame: 12 Months
Secondary outcomes:
measure: Mean Oswestry Disability Index Change
timeFrame: 24 Months
measure: Mean Neck Disability Index Change
timeFrame: 24 months
measure: Safety Events
timeFrame: 24 months
measure: Fusion Status
timeFrame: 3, 6, 12 and 24 months
measure: Angular Motion
timeFrame: 3, 6, 12 and 24 months
measure: Translational Motion
timeFrame: 3, 6, 12 and 24 months
measure: Bridging Bone
timeFrame: 3, 6, 12 and 24 months
measure: Disc Height
timeFrame: PreOp, 2 and 6 weeks, 3, 6, 12 and 24 months
measure: Device Migration
timeFrame: 6 weeks, 3, 6, 12 and 24 months
measure: Subsidence
timeFrame: 6 weeks, 3, 6, 12 and 24 months
measure: Adjacent Segment Degeneration
timeFrame: 2 and 6 weeks, 3, 6, 12 and 24 months
measure: Device and Supplemental Fixation Breakage
timeFrame: 2 and 6 weeks, 3, 6, 12 and 24 months
measure: Visual Analogue Scale Pain Severity
timeFrame: PreOp, 2 and 6 weeks, 3, 6, 12 and 24 months
measure: EQ-5D
timeFrame: PreOp, 2 and 6 weeks, 3, 6, 12 and 24 months
measure: Prolo Scale
timeFrame: PreOp, 2 and 6 weeks, 3, 6, 12 and 24 months
Other outcomes:
Locations:
city: Shreveport
country: United States
facility: Spine Institute of Louisiana Foundation, Inc.
state: Louisiana
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: The Spine Clinic of Oklahoma City
state: Oklahoma
city: Falls Church
country: United States
facility: Inova Neurosciences Research
state: Virginia
Study officials:
References: