A Focused Registry on Anterior Cervical Interbody Spacer ACIS (ACIS)

August 11, 2020 updated by: AO Clinical Investigation and Publishing Documentation

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brasschaat, Belgium, 2020
        • AZ Klina
      • Duffel, Belgium, 2570
        • AZ Sint Maarten

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AO Clinical Investigation and Publishing Documentation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

December 10, 2013

First Submitted That Met QC Criteria

December 19, 2013

First Posted (Estimate)

December 20, 2013

Study Record Updates

Last Update Posted (Actual)

August 13, 2020

Last Update Submitted That Met QC Criteria

August 11, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FR_ACIS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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