A Focused Registry on Anterior Cervical Interbody Spacer ACIS (NCT02016794) | Clinical Trial Compass
CompletedNot Applicable
A Focused Registry on Anterior Cervical Interbody Spacer ACIS
Belgium9 participantsStarted 2014-02
Plain-language summary
Degenerative cervical spine conditions lead to chronic neck and arm pain. Surgical treatment may require anterior decompression and fusion, which usually is established with a cage implant. The Anterior Cervical Interbody Spacer (ACIS) is such a cage.
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 21 years or older
* Degenerative cervical condition that requires anterior decompression and fusion in a single or multiple levels
* Degenerative cervical disc disease C3 through Th1 or
* Ruptured and herniated discs C3 through Th1
* Ability to understand the content of the patient information / informed consent form
* Willingness and ability to participate in the registry according to the registry plan (RP)
* Signed and dated IRB / EC-approved written informed consent
Exclusion Criteria:
* Spinal tumor
* Osteoporosis
* Cervical trauma and instability
* Any not medically managed severe systemic disease (ie. infection)
* Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
* Pregnancy or women planning to conceive within the registry period
* Prisoner
* Participation in any other medical device or medicinal product clinical investigation or registry within the previous month that could influence the results of the present registry
Intraoperative exclusion criteria:
* Intraoperative decision to use implants other than the device under investigation
What they're measuring
1
Effect of neck pain on everyday life measured by the Neck Disability Index (NDI).
Timeframe: 6 months
Trial details
NCT IDNCT02016794
SponsorAO Clinical Investigation and Publishing Documentation