A Focused Registry on Anterior Cervical Interbody Spacer ACIS

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 11, 2014
Last verified: July 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Locations
Belgium
AZ Klina Not yet recruiting
Brasschaat, Belgium, 2020
Contact: Robert Hes, Dr.         
Principal Investigator: Robert Hes, Dr.         
AZ Sint Maarten Recruiting
Duffel, Belgium, 2570
Contact: Anton Veyt, Dr.         
Principal Investigator: Anton Veyt, 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: July 11, 2014
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 October 19, 2014