Degenerative Disc DiseaseNCT02108249
Annex™ Adjacent Level System for Treatment of Adjacent Level Disease
An observational study of Degenerative Disc Disease and Adjacent Level Disease, run by Spine Wave at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the clinical, radiological, and surgical outcomes of the Annex™ Adjacent Level System for the treatment of adjacent level disease of the lumbar spine. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Degenerative Disc Disease, Adjacent Level Disease
- What is being tested?
- Annex™ Adjacent Level System
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Dec 2019
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subject population for both the treatment and control groups will include adult (skeletally mature) men and women who were previously implanted with rigid posterior fixation (pedicle screw/rod constructs) in the thoracolumbar spine and who later developed adjacent level disease (ALD) at a lumbar level.
Who may be able to join
- Men or women 18-85 years of age
- Single level adjacent level segment disease (ALD) in the lumbar spine (L1-S1).
Who cannot join
- trauma, tumor, pseudoarthrosis, revision, or same-level recurrent stenosis
- cervical fusion candidates
- extraspinal cause of back pain
- local or systemic infection
- pregnant / able to become pregnant and not following a reliable contraceptive method
- Severe osteoporosis or osteopenia
Show all 17Show fewer
- Morbid obesity defined as BMI > 40
- Anatomy or other factors that prohibit safe surgical access to the surgical site
- Allergy or sensitivity to any component of the treatment procedure
- Inadequate tissue coverage over the operative site
- Inadequate bone stock or bone quality
- Fever or leukocytosis
- Uncorrectable coagulopathy or hemorrhagic diathesis
- Cardiopulmonary conditions that present prohibitive anesthesia risk
- Neuromuscular disease or disorder
- Mental illness
- Has an active workman's compensation claim
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Neurosurgery and Spine
Charlotte, North Carolina, 28204
About this study
The purpose of this study is to evaluate the clinical, radiological, and surgical outcomes of the Annex™ Adjacent Level System for the treatment of adjacent level disease of the lumbar spine. The Annex™ Adjacent Level System is a spinal fixation system intended to be used with commercially available pedicle screw fixation systems in order to extend existing pedicle screw constructs. Subjects will be evaluated over a 2 year period and compared to historical control.
- Conditions
- Degenerative Disc Disease, Adjacent Level Disease
- Being tested
- Annex™ Adjacent Level System
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Annex™ Adjacent Level SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Annex Group | Patients prospectively treated with Annex™ Adjacent Level System Receives: Device: Annex™ Adjacent Level System | |
| Retrospective Control | Patients previously treated for adjacent level disease using other systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Improvement in Operative/Discharge parameters including surgical time and hospital stay
Measured: within 30 days after treatment
Surgical Complication rate compared to retrospective chart review
Measured: Within 30 days of treatment
Secondary outcomes (4)
% Pain reduction on VAS
Measured: Up to 2 years post-treatment
% Improvement in Disability using ODI
Measured: Up to 2 years post-treatment
% Improvement in Quality of Life using SF-36
Measured: Up to 2 years post-treatment
% Patient Satisfaction with procedure
Measured: Up to 2 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spine Wave
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108249
- Sponsor's protocol ID
- SW-ANX1401
- Status last verified
- Oct 2020
- First submitted
- 2 Apr 2014
- Last updated
- 22 Oct 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Annex™ Adjacent Level System for Treatment of Adjacent Level Disease
- ClinicalTrials.gov ID
- NCT02108249
- Acronym / sponsor ID
- SW-ANX1401
- Conditions
- Degenerative Disc Disease, Adjacent Level Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Spine WaveIndustry (pharma, biotech, devices)
- Study start
- Apr 2014 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 9 Apr 2014 (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.
The purpose of this study is to evaluate the clinical, radiological, and surgical outcomes of the Annex™ Adjacent Level System for the treatment of adjacent level disease of the lumbar spine. The Annex™ Adjacent Level System is a spinal fixation system intended to be used with commercially available pedicle screw fixation systems in order to extend existing pedicle screw constructs. Subjects will be evaluated over a 2 year period and compared to historical control.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Annex Group | – | Device: Annex™ Adjacent Level SystemPatients prospectively treated with Annex™ Adjacent Level System |
| Retrospective Control | – | –Patients previously treated for adjacent level disease using other systems |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subject population for both the treatment and control groups will include adult (skeletally mature) men and women who were previously implanted with rigid posterior fixation (pedicle screw/rod constructs) in the thoracolumbar spine and who later developed adjacent level disease (ALD) at a lumbar level.
Key inclusion criteria (2 listed)
- Men or women 18-85 years of age
- Single level adjacent level segment disease (ALD) in the lumbar spine (L1-S1).
Key exclusion criteria (17 listed)
- trauma, tumor, pseudoarthrosis, revision, or same-level recurrent stenosis
- cervical fusion candidates
- extraspinal cause of back pain
- local or systemic infection
- pregnant / able to become pregnant and not following a reliable contraceptive method
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Annex™ Adjacent Level System | Device | Annex Group |
Primary outcome
% Improvement in Operative/Discharge parameters including surgical time and hospital stay
Time frame: within 30 days after treatment
Surgical Complication rate compared to retrospective chart review
Time frame: Within 30 days of treatment
4 secondary outcomes
% Pain reduction on VAS
Time frame: Up to 2 years post-treatment
% Improvement in Disability using ODI
Time frame: Up to 2 years post-treatment
% Improvement in Quality of Life using SF-36
Time frame: Up to 2 years post-treatment
% Patient Satisfaction with procedure
Time frame: Up to 2 years post-treatment
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 22 Oct 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease and Adjacent Level Disease, run by Spine Wave at 1 site in United States.
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 2 inclusion and 17 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 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
% Improvement in Operative/Discharge parameters including surgical time and hospital stay (time frame: within 30 days after treatment). The study lists 2 primary outcomes in all. 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 22 Oct 2020.