A Focused Registry on Anterior Cervical Interbody Spacer ACIS
ACIS
1 other identifier
observational
9
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2014
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2013
CompletedFirst Posted
Study publicly available on registry
December 20, 2013
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedAugust 13, 2020
August 1, 2020
1.9 years
December 10, 2013
August 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of neck pain on everyday life measured by the Neck Disability Index (NDI).
6 months
Secondary Outcomes (4)
Pain
Baseline; 1-2days; 6 weeks; 6 months
Handling details
Intraoperative
Length of Hospital Stay
Expected average of 5 days
Adverse Events
Intra and post operative
Study Arms (1)
Patients
Patients suffering from degenerative cervical condition that requires anterior decompression and fusion in a single or multiple levels
Eligibility Criteria
Patients undergoing surgery for degenerative cervical condition that requires anterior decompression and fusion in a single or multiple levels
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
AZ Klina
Brasschaat, 2020, Belgium
AZ Sint Maarten
Duffel, 2570, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2013
First Posted
December 20, 2013
Study Start
February 1, 2014
Primary Completion
January 1, 2016
Study Completion
June 1, 2017
Last Updated
August 13, 2020
Record last verified: 2020-08