CClinicalTrials.gg
Sign In
CompletedNCT02016794ACISUpdated Aug 13, 2020

A Focused Registry on Anterior Cervical Interbody Spacer ACIS

An observational study in Degenerative Cervical Spine, sponsored by AO Clinical Investigation and Publishing Documentation. Completed at 2 sites in Belgium. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2020-08-13.

Sponsored by AO Clinical Investigation and Publishing Documentation · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
9
Ages
21 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Degenerative Cervical Spine

Keywords

  • cervical
  • interbody
  • spacer
  • degenerative
  • pain
  • neck
  • decompression
  • fusion
  • implant
03

In context

Lead sponsor

AO Clinical Investigation and Publishing Documentation is the lead sponsor of 49 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients undergoing surgery for degenerative cervical condition that requires anterior decompression and fusion in a single or multiple levels

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
9 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • Patients

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

06

What researchers measure

Primary outcomes

  1. Effect of neck pain on everyday life measured by the Neck Disability Index (NDI).

    Time frame: 6 months

Secondary outcomes

  1. Pain

    Numeric Rating Scale

    Time frame: Baseline; 1-2days; 6 weeks; 6 months

  2. Handling details

    easiness of using ACIS, overall satisfaction with ACIS, time of surgery

    Time frame: Intraoperative

  3. Length of Hospital Stay

    From the day of the surgery until the day of discharge

    Time frame: Expected average of 5 days

  4. Adverse Events

    Time frame: Intra and post operative

07

Study locations

2 sites
  • AZ Klina
    Brasschaat, 2020, Belgium
  • AZ Sint Maarten
    Duffel, 2570, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02016794
Lead sponsor
AO Clinical Investigation and Publishing Documentation
Responsible party
Sponsor
First posted
Dec 20, 2013
Start date
Feb 2014
Primary completion
Jan 2016
Completion
Jun 2017
Last update
Aug 13, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

AO Clinical Investigation and Publishing Documentation

Start the discussion