A Focused Registry on Anterior Cervical Interbody Spacer ACIS
This trial is active, not recruiting.
|Condition||degenerative cervical spine|
|Sponsor||AO Clinical Investigation and Documentation|
|Start date||February 2014|
|End date||June 2017|
|Trial size||25 participants|
|Trial identifier||NCT02016794, FR_ACIS|
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.
Patients suffering from degenerative cervical condition that requires anterior decompression and fusion in a single or multiple levels
Effect of neck pain on everyday life measured by the Neck Disability Index (NDI).
time frame: 6 months
time frame: Baseline; 1-2days; 6 weeks; 6 months
time frame: Intraoperative
Length of Hospital Stay
time frame: Expected average of 5 days
time frame: Intra and post operative
Male or female participants at least 21 years old.
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
|Official title||A Focused Registry on Anterior Cervical Interbody Spacer Procedures in Patients With Cervical Spine Degeneration|
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