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OpenTrials
Completed

NCT Number: NCT02016794

A Focused Registry on Anterior Cervical Interbody Spacer ACIS

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.

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Key information

Conditions

Degenerative Cervical Spine Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ Klina, Brasschaat, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

    Numeric Rating Scale

  2. Handling details

    Time frame: Intraoperative

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

  3. Length of Hospital Stay

    Time frame: Expected average of 5 days

    From the day of the surgery until the day of discharge

  4. Adverse Events

    Time frame: Intra and post operative

Sponsors and collaborators

Lead sponsor

AO Clinical Investigation and Publishing Documentation

Other

Registry information

Official study title

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

Acronym: ACIS

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Dec 20, 2013
Registry last updated
Aug 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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