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

K2M, Inc.4 sites in 1 country28 target enrollmentDecember 7, 2021

ConditionsDegenerative Disc Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Degenerative Disc Disease
Sponsor: K2M, Inc.
Enrollment: 28
Locations: 4
Primary Endpoint: Mean Neck Disability Index Change
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 7, 2021

End Date

March 21, 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

K2M, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Must be planned to undergo spinal fusion surgery utilizing Stryker Interbody Systems for on label indications, which are listed below as inclusion criteria.
•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.

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

Mean Neck Disability Index Change

Time Frame: 12 Months

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

Mean Oswestry Disability Index Change

Time Frame: 12 Months

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

Secondary Outcomes

Mean Neck Disability Index Change(24 months)
Angular Motion(3, 6, 12 and 24 months)
Translational Motion(3, 6, 12 and 24 months)
Adjacent Segment Degeneration(2 and 6 weeks, 3, 6, 12 and 24 months)
Mean Oswestry Disability Index Change(24 Months)
Device Migration(6 weeks, 3, 6, 12 and 24 months)
Prolo Scale(PreOp, 2 and 6 weeks, 3, 6, 12 and 24 months)
Safety Events(24 months)
Fusion Status(3, 6, 12 and 24 months)
Bridging Bone(3, 6, 12 and 24 months)
Subsidence(6 weeks, 3, 6, 12 and 24 months)
Disc Height(PreOp, 2 and 6 weeks, 3, 6, 12 and 24 months)
Device and Supplemental Fixation Breakage(2 and 6 weeks, 3, 6, 12 and 24 months)
Visual Analogue Scale Pain Severity(PreOp, 2 and 6 weeks, 3, 6, 12 and 24 months)
EQ-5D(PreOp, 2 and 6 weeks, 3, 6, 12 and 24 months)