Interbody Systems: Post Market Clinical Follow-up Study

Degenerative Disc Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04911257
• Other study ID #: CAS-017
• Status: Recruiting
• Start date: December 7, 2021
• Est. completion date: February 1, 2027

Study information

• Verified date: March 2022
• Source: K2M, Inc.
• Contact: Ajay Rastogi, BS
• Phone: 201-749-2347
• Email: ajay.rastogi[@]stryker.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: February 1, 2027
• Est. primary completion date: December 7, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

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.

Locations

Country	Name	City	State
United States	The Spine Clinic of Oklahoma City	Oklahoma City	Oklahoma
United States	Spine Institute of Louisiana Foundation, Inc.	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
K2M, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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