Degenerative Cervical SpineACISNCT02016794
A Focused Registry on Anterior Cervical Interbody Spacer ACIS
An observational study of Degenerative Cervical Spine, run by AO Clinical Investigation and Publishing Documentation at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Degenerative Cervical Spine
- How many people
- 9 participants
- Where
- 2 sitesBelgium
- Study dates
- Feb 2014to Jun 2017
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing surgery for degenerative cervical condition that requires anterior decompression and fusion in a single or multiple levels
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Focused Registry on Anterior Cervical Interbody Spacer Procedures in Patients With Cervical Spine Degeneration
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.
- Conditions
- Degenerative Cervical Spine
- Keywords
- cervical, interbody, spacer, degenerative, pain, neck, decompression, fusion, implant
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients suffering from degenerative cervical condition that requires anterior decompression and fusion in a single or multiple levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of neck pain on everyday life measured by the Neck Disability Index (NDI).
Measured: 6 months
Secondary outcomes (4)
Pain
Numeric Rating Scale
Measured: Baseline; 1-2days; 6 weeks; 6 months
Handling details
easiness of using ACIS, overall satisfaction with ACIS, time of surgery
Measured: Intraoperative
Length of Hospital Stay
From the day of the surgery until the day of discharge
Measured: Expected average of 5 days
Adverse Events
Measured: Intra and post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionJan 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Cervical SpineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016794
- Sponsor's protocol ID
- FR_ACIS
- Acronym
- ACIS
- Status last verified
- Aug 2020
- First submitted
- 10 Dec 2013
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Focused Registry on Anterior Cervical Interbody Spacer Procedures in Patients With Cervical Spine Degeneration
- ClinicalTrials.gov ID
- NCT02016794
- Acronym / sponsor ID
- ACIS / FR_ACIS
- Conditions
- Degenerative Cervical Spine
- Keywords
- cervical, interbody, spacer, degenerative, pain, neck, decompression, fusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 20 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients suffering from degenerative cervical condition that requires anterior decompression and fusion in a single or multiple levels |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgery for degenerative cervical condition that requires anterior decompression and fusion in a single or multiple levels
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effect of neck pain on everyday life measured by the Neck Disability Index (NDI).
Time frame: 6 months
4 secondary outcomes
Pain
Time frame: Baseline; 1-2days; 6 weeks; 6 months
Handling details
Time frame: Intraoperative
Length of Hospital Stay
Time frame: Expected average of 5 days
Adverse Events
Time frame: Intra and post operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
Related trials for Degenerative Cervical Spine
Not yet recruiting
Conservative Care Versus Decompression Trial for Degenerative Cervical Myelopathy Pilot
Degenerative Cervical Myelopathy
RecruitingObservational study
PMCF Study Fortilink-SC
Degenerative Disc Disease in Cervical Spine, Stenosis Cervical Spine
Enrolling by invitation
Physiotherapy and Osteopathic Treatment for Pain in the Cervical and Lumbar Spine and Temporomandibular Joints
Disc Degenerative Disease, Spine Degeneration
RecruitingObservational study
Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical
Spine Fracture, Degenerative Disc Disease
Not yet recruiting
Evaluation of the Safety and Effectiveness of the CORUS™ Posterior Cervical Stabilization System 3D (PCSS 3D) for the Treatment of 2-level Cervical Degenerative Disease
Degenerative Disc Disease(DDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Cervical Spine, run by AO Clinical Investigation and Publishing Documentation at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of neck pain on everyday life measured by the Neck Disability Index (NDI). (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.