Degenerative Cervical Spine Clinical Trial
— ACISOfficial title:
A Focused Registry on Anterior Cervical Interbody Spacer Procedures in Patients With Cervical Spine Degeneration
| NCT number | NCT02016794 |
| Other study ID # | FR_ACIS |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | February 2014 |
| Est. completion date | June 2017 |
| Verified date | August 2020 |
| Source | AO Innovation Translation Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 9 |
| Est. completion date | June 2017 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | AZ Klina | Brasschaat | |
| Belgium | AZ Sint Maarten | Duffel |
| Lead Sponsor | Collaborator |
|---|---|
| AO Clinical Investigation and Publishing Documentation |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Effect of neck pain on everyday life measured by the Neck Disability Index (NDI). | 6 months | ||
| Secondary | Pain | Numeric Rating Scale | Baseline; 1-2days; 6 weeks; 6 months | |
| Secondary | Handling details | easiness of using ACIS, overall satisfaction with ACIS, time of surgery | Intraoperative | |
| Secondary | Length of Hospital Stay | From the day of the surgery until the day of discharge | Expected average of 5 days | |
| Secondary | Adverse Events | Intra and post operative |