A Focused Registry on Anterior Cervical Interbody Spacer ACIS

AO Clinical Investigation and Publishing Documentation

Status: Completed

Conditions: Degenerative Cervical Spine

Study type: Observational

Funder types: Other

Identifiers

NCT02016794

FR_ACIS

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

9 participants in 1 patient group

Patients

Description:

Patients suffering from degenerative cervical condition that requires anterior decompression and fusion in a single or multiple levels