Interbody Systems: Post Market Clinical Follow-up Study

NCT04911257 | Terminated FDA Device

• 1 other identifier: CAS-017
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 4

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.

Conditions

Degenerative Disc Disease

Keywords

Spondylolisthesis; Degenerative Scoliosis; Retrolisthesis.

Outcome Measures

Primary Outcomes (2)

• Mean Oswestry Disability Index Change

  Oswestry Disability Index (ODI) (lumbar) improvement from baseline to 12 months. Scale of Oswestry Disability Index from 0-50, 0 meaning no disability.

  12 Months

• Mean Neck Disability Index Change

  Neck Disability Index (NDI) (cervical) improvement from baseline to 12 months. Scale of Neck Disability Index from 0-50, 0 meaning no disability.

  12 Months

Secondary Outcomes (15)

• Mean Oswestry Disability Index Change

  24 Months

• Mean Neck Disability Index Change

  24 months

• Safety Events

  24 months

• Fusion Status

  3, 6, 12 and 24 months

• Angular Motion

  3, 6, 12 and 24 months

Study Arms (1)

Degenerate Disc Disease

Subjects who will undergo spinal fusion surgery utilizing Stryker Interbody Systems.

Device: Cervical or Lumbar Spinal fusion

Interventions

Cervical or Lumbar Spinal fusion DEVICE

This is a prospective, multi-center study of subjects who will undergo spinal fusion surgery utilizing certain Stryker Interbody Systems.

Degenerate Disc Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Willingness and ability to comply with the requirements of the protocol including follow up requirements.
• Willing and able to sign a study specific informed consent form.
• Skeletally mature (age at least 18 years) and:
• Have had six months of lumbar non operative therapy.
• Have had six weeks of cervical non operative treatment.
• Will undergo interbody fusion at one or two contiguous levels (Chesapeake Cervical Ti is only indicated for use at one level) at:
• L2 L5 for Cascadia lateral hyperlordotic (\>22°l).
• L2 S1 for all other lumbar interbody systems.
• C2 T1 for cervical interbody systems.
• 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.

You may not qualify if:

• Any condition where the implants interfere with anatomical structures or precludes the benefit of spinal surgery.
• For the Tritanium and Monterey AL systems: Any neuromuscular deficit which places an unsafe load on the device during the healing period.
• For the Cascadia, Chesapeake, Mojave and Sahara systems: Metabolic disorders of calcified tissues.
• Biological factors such as smoking or using nonsteroidal anti inflammatory agents/ anticoagulants.
• Immunosuppressive disorders.
• Grossly distorted anatomy. N/A for Tritanium TL, Tritanium Cervical and Monterey AL
• Inadequate tissue coverage or open wounds.
• Infection at index level(s) at the time of surgery.
• Patients with known sensitivity to materials in the device.
• 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.
• Obesity.
• 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.
• 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.
• For the Tritanium, Monterey AL, Chesapeake and Sahara systems: Prior fusion at the level to be treated (as indicated in the IFU).

Sponsors & Collaborators

• K2M, Inc.: lead

Study Sites (4)

Spine Institute of Louisiana Foundation, Inc.

Shreveport, Louisiana, 71101, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Spine Clinic of Oklahoma City

Oklahoma City, Oklahoma, 73114, United States

Location

Inova Neurosciences Research

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spondylolisthesis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: June 3, 2021
• Study Start: December 7, 2021
• Primary Completion: February 12, 2025
• Study Completion: March 21, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)