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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Patients suffering from degenerative cervical condition that requires anterior decompression and fusion in a single or multiple levels

Primary Outcomes

Effect of neck pain on everyday life measured by the Neck Disability Index (NDI).
time frame: 6 months

Secondary Outcomes

time frame: Baseline; 1-2days; 6 weeks; 6 months
Handling details
time frame: Intraoperative
Length of Hospital Stay
time frame: Expected average of 5 days
Adverse Events
time frame: Intra and post operative

Eligibility Criteria

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

Additional Information

Official title A Focused Registry on Anterior Cervical Interbody Spacer Procedures in Patients With Cervical Spine Degeneration
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by AO Clinical Investigation and Documentation.