Trial record 4 of 27 for:    Open Studies | "Cervical Vertebrae"

A Focused Registry on Anterior Cervical Interbody Spacer ACIS

This study is not yet open for participant recruitment.
Verified December 2013 by AO Clinical Investigation and Documentation
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT02016794
First received: December 10, 2013
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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.


Condition
Degenerative Cervical Spine

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: A Focused Registry on Anterior Cervical Interbody Spacer Procedures in Patients With Cervical Spine Degeneration

Resource links provided by NLM:


Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • Effect of neck pain on everyday life measured by the Neck Disability Index (NDI). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain [ Time Frame: Baseline; 1-2days; 6 weeks; 6 months ] [ Designated as safety issue: No ]
    Numeric Rating Scale

  • Handling details [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    easiness of using ACIS, overall satisfaction with ACIS, time of surgery

  • Length of Hospital Stay [ Time Frame: Expected average of 5 days ] [ Designated as safety issue: No ]
    From the day of the surgery until the day of discharge

  • Adverse Events [ Time Frame: Intra and post operative ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: February 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients
Patients suffering from degenerative cervical condition that requires anterior decompression and fusion in a single or multiple levels

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02016794

Contacts
Contact: Andreas Faeh andreas.faeh@aofoundation.org

Locations
Belgium
ZNA Middelheim Not yet recruiting
Antwerpen, Belgium, 2020
Contact: Robert Hes, Dr.         
Sponsors and Collaborators
AO Clinical Investigation and Documentation
  More Information

No publications provided

Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT02016794     History of Changes
Other Study ID Numbers: FR_ACIS
Study First Received: December 10, 2013
Last Updated: December 19, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by AO Clinical Investigation and Documentation:
cervical
interbody
spacer
degenerative
pain
neck
decompression
fusion
implant

ClinicalTrials.gov processed this record on April 20, 2014