A Focused Registry on Anterior Cervical Interbody Spacer ACIS

Completed

• Conditions: Degenerative Cervical Spine

• Registration Number: NCT02016794
• Lead Sponsor: AO Clinical Investigation and Publishing Documentation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-20
• Study Start: 2014-02
• Primary Completion: 2016-01
• Study Completion: 2017-06
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-11
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

AZ Klina; 🇧🇪 Brasschaat, Belgium

AZ Sint Maarten; 🇧🇪 Duffel, Belgium