A Focused Registry on Anterior Cervical Interbody Spacer ACIS

A Focused Registry on Anterior Cervical Interbody Spacer Procedures in Patients With Cervical Spine Degeneration

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02016794

Acronym

ACIS

Enrollment

Registered

2013-12-20

Start date

2014-02-28

Completion date

2017-06-30

Last updated

2020-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Cervical Spine

Keywords

cervical, interbody, spacer, degenerative, pain, neck, decompression, fusion, implant

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Pain	Baseline; 1-2days; 6 weeks; 6 months	Numeric Rating Scale
Handling details	Intraoperative	easiness of using ACIS, overall satisfaction with ACIS, time of surgery
Length of Hospital Stay	Expected average of 5 days	From the day of the surgery until the day of discharge
Adverse Events	Intra and post operative	—

Countries

Belgium

Outcome results