A Focused Registry on Anterior Cervical Interbody Spacer ACIS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Degenerative Cervical Spine

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

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

No interventions assigned to this group

Eligibility Criteria

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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 decision to use implants other than the device under investigation

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No