Interbody Systems: Post Market Clinical Follow-up Study

Multi Center, Prospective Evaluation for Clinical and Radiographic Outcomes Utilizing Stryker Spine Cervical and Lumbar Interbody Systems: Observational Post Market Clinical Follow up Study

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.

Study Overview

• Status: Recruiting
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Device: Cervical or Lumbar Spinal fusion

• Study Type: Observational
• Enrollment (Anticipated): 460

Contacts and Locations

• Study Contact: Name: Ajay Rastogi, BS; Phone Number: 201-749-2347; Email: ajay.rastogi@stryker.com
• Study Contact Backup: Name: Joerg Kintscher, PhD; Phone Number: +49 (0) 171 915 3032; Email: joerg.kintscher@stryker.com

Study Locations

• United States
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Recruiting
      • Spine Institute of Louisiana Foundation, Inc.
      • Contact: Cody McConnell; Phone Number: 318-629-6341; Email: CMcConnell@louisianaspine.org
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73114
      • Recruiting
      • The Spine Clinic of Oklahoma City
      • Contact: Ashley Mason; Phone Number: 405-419-5614; Email: amason@okss.com
      • Principal Investigator: Brett Braly, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Degenerate Disc Disease; Subjects who will undergo spinal fusion surgery utilizing Stryker Interbody Systems.	Device: Cervical or Lumbar Spinal fusion; This is a prospective, multi-center study of subjects who will undergo spinal fusion surgery utilizing certain Stryker Interbody Systems.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Oswestry Disability Index Change	Oswestry Disability Index (ODI) (lumbar) change from baseline to 24 months. Scale of Oswestry Disability Index from 0-50, 0 meaning no disability.	24 Months
Mean Neck Disability Index Change	Neck Disability Index (NDI) (cervical) change from baseline to 24 months. Scale of Neck Disability Index from 0-50, 0 meaning no disability.	24 months
Safety Events	The following safety events will be collected through 24 months, including the following: (MedDRA will be used to define these events); Serious adverse events; Device-related adverse events; Procedure-related adverse events; Operative site adverse events; Secondary spine surgeries (secondary interventions); Adverse event that negatively impacts the primary endpoint	24 months
Fusion Status	Fusion will be derived from a logical analysis of three component factors: angular motion, translational motion, and bridging bone. Each treated level must be considered fused in order for the subject to be considered a radiographic success.	3, 6, 12 and 24 months
Angular Motion	Angular Motion will be measured from lateral flexion-extension radiographs. Angular motion, also known as rotation, is defined as the change in angle between the adjacent endplates of the motion segment. Angular Motion will be reported in units of degrees	3, 6, 12 and 24 months
Translational Motion	Translational Motion will be measured from lateral flexion-extension radiographs Translational motion is defined as the displacement of the posterior-inferior corner of the superior vertebra in a direction defined parallel to the superior endplate of the inferior vertebra. Translational Motion - Cervical will be reported in units of millimeters and percentage (%) of the anteroposterior (AP) length of the superior endplate of the inferior vertebra.	3, 6, 12 and 24 months
Bridging Bone	Interbody Bridging Bone will be graded in accordance with the following definitions: Absent: No evidence of continuous bridging bone from endplate to endplate.; Present: Presence of continuous bridging bone from endplate to endplate.	3, 6, 12 and 24 months
Disc Height	Disc Height will be calculated from neutral lateral radiographs. Disc Height will be reported in units of millimeters and percentage (%) of the AP length of the superior endplate of the inferior vertebra. Average Disc Height	PreOp, 2 and 6 weeks, 3, 6, 12 and 24 months
Device Migration	Migration will be assessed relative to the Week 2 time point or earliest available post-operative visit. Migration will be measured in millimeters.	6 weeks, 3, 6, 12 and 24 months
Subsidence	Subsidence will be assessed relative to the Week 2 time point or earliest available post-operative visit, Subsidence will be measured in millimeters.	6 weeks, 3, 6, 12 and 24 months
Adjacent Segment Degeneration	Adjacent Segment Degeneration will be assessed at the adjacent levels using the Kellgren-Lawrence Osteoarthritis Grade.	2 and 6 weeks, 3, 6, 12 and 24 months
Device and Supplemental Fixation Breakage	Device and Supplemental Fixation Breakage will be assessed via all available x-ray images	2 and 6 weeks, 3, 6, 12 and 24 months
Visual Analogue Scale Pain Severity	A Visual Analogue Scale patient questionnaire will be used to define the pain in the specific regions (cervical or lumbar) in the course of the study. 0 will be defined as "no pain" and 10 the Worst Possible Pain.	PreOp, 2 and 6 weeks, 3, 6, 12 and 24 months
EQ-5D	The EQ-5D questionnaire is a standard generic patient questionnaire used to determine the health-related quality of life changes in the course of the study.	PreOp, 2 and 6 weeks, 3, 6, 12 and 24 months
Prolo Scale	The Prolo Scale is a 10-point scale consisting of only two questions evaluating the functional and economic status of the patient in the course of this study.	PreOp, 2 and 6 weeks, 3, 6, 12 and 24 months

Collaborators and Investigators

• Sponsor: K2M, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2021
• Primary Completion (Anticipated): December 7, 2026
• Study Completion (Anticipated): February 1, 2027

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: June 1, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Spondylolisthesis; Degenerative Scoliosis; Retrolisthesis.
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: CAS-017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes