Interbody Systems: Post Market Clinical Follow-up Study (NCT04911257) | Clinical Trial Compass
TerminatedNot Applicable
Interbody Systems: Post Market Clinical Follow-up Study
Stopped: Sponsor terminated the study
United States28 participantsStarted 2021-12-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Must be planned to undergo spinal fusion surgery utilizing Stryker Interbody Systems for on label indications, which are listed below as inclusion criteria.
ā. Diagnosed with degenerative disc disease (DDD).
ā. Willingness and ability to comply with the requirements of the protocol including follow up requirements.
ā. Willing and able to sign a study specific informed consent form.
ā. Skeletally mature (age at least 18 years) and:
ā. Have had six months of lumbar non operative therapy.
ā. Have had six weeks of cervical non operative treatment.
ā. Will undergo interbody fusion at one or two contiguous levels (Chesapeake Cervical Ti is only indicated for use at one level) at:
Exclusion criteria
ā. Any condition where the implants interfere with anatomical structures or precludes the benefit of spinal surgery.