Disc Degeneration;CervicalNCT03871400
The NanoStrand Clinical Study
A study testing Anterior cervical discectomy and fusion in people with Disc Degeneration;Cervical, run by SeaSpine, Inc. at 11 sites in United States.
Trial summary
A prospective, multi-center, randomized, self-controlled, single-blinded, clinical study evaluating the NanoMetalene implant as compared to the PEEK and allograft implants in ACDF for the treatment of cervical degenerative disc disease (DDD). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Disc Degeneration;Cervical
- What is being tested?
- Anterior cervical discectomy and fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 11 sitesUnited States
- Study dates
- 18 Nov 2018to 30 Jan 2021
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cervical degenerative disc disease
- Requires primary spinal fusion from C3-C7
- Minimum of 6 weeks of non-operative treatment
- Signed informed consent form
Who cannot join
- Uncontrolled type I or II diabetes mellitus
- Morbid obesity
- Documented history of alcohol or drug abuse
- Fever or leukocytosis
- Current systemic infection
- Active malignancy and/or current chemotherapy
Show all 12Show fewer
- Known history of osteoporosis
- Prior fusion or total disc replacement at the operative level or an adjacent level
- Infection of the operative site
- Use of implants from other systems
- Pregnancy
- Participation in another research study
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Emory
Atlanta, Georgia, 30324
University of Colorado Hospital
Aurora, Colorado, 80045
Northwestern University
Chicago, Illinois, 60611
Hughston Clinic
Columbus, Georgia, 31909
Spine Colorado
Durango, Colorado, 81301
OrthIndy
Indianapolis, Indiana, 46278
Henry Ford
Jackson, Michigan, 49201
University of California, San Diego
La Jolla, California, 92093
University of Southern California
Los Angeles, California, 90033
Barrow Brain and Spine
Phoenix, Arizona, 85013
UCLA Health
Santa Monica, California, 90401
About this study
Official title: Comparison of Early Fusion Using a NanoMetalene® Implant Versus Both PEEK and Allograft Implants in Anterior Cervical Discectomy and Fusion (ACDF) With OsteoStrand™ Demineralized Bone Fibers
A prospective, multi-center, randomized, self-controlled, single-blinded, clinical study evaluating the NanoMetalene implant as compared to the PEEK and allograft implants in ACDF for the treatment of cervical degenerative disc disease (DDD).
Read the detailed description
PEEK: Polyetheretherketone ACDF: Anterior cervical discectomy and fusion
- Conditions
- Disc Degeneration;Cervical
- Being tested
- Anterior cervical discectomy and fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior cervical discectomy and fusionProcedure or surgery
primary, 2-level, contiguous
| Study group | Role | What they receive |
|---|---|---|
| NanoMetalene/PEEK | Other | Not described Receives: Procedure: Anterior cervical discectomy and fusion |
| NanoMetalene/Allograft | Other | Not described Receives: Procedure: Anterior cervical discectomy and fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of cervical spinal levels for NanoMetalene vs PEEK interbody implants that have achieved fusion as determined by Computed Tomography (CT) analysis
Proportion of cervical spinal levels for NanoMetalene vs PEEK interbody implants that have achieved fusion as determined by Computed Tomography (CT) analysis
Measured: 12 months
Secondary outcomes (6)
Secondary CT Analysis: PEEK
Proportion of cervical spinal levels for NanoMetalene vs PEEK interbody implants that have achieved fusion as determined by Computed Tomography (CT) analysis
Measured: 12 months
Secondary CT Analysis: Allograft
Proportion of cervical spinal levels for NanoMetalene vs Allograft implants that have achieved fusion as determined by Computed Tomography (CT) analysis
Measured: 12 months
Secondary X-Ray Analysis
Proportion of cervical spinal levels for NanoMetalene vs PEEK and Allograft implants that have achieved fusion as determined by x-ray analysis
Measured: 24 months
Clinical Outcomes: NDI
Improvement of clinical outcomes (NDI) for all enrolled patients. Improvement is a reduction of scores for all clinical outcomes. Results will be shown as change from baseline to 24 month follow-up.
The NDI is an index derived from the Neck Disability Index Pain Questionnaire used by surgeons, clinicians and researchers to quantify disability for neck pain. Scores are from 0-100 and a lower score represents a better score.
Measured: 24 months
Clinical Outcomes: VAS Arm
Improvement of clinical outcomes (VAS Arm) for all enrolled patients. Improvement is a reduction of scores for all clinical outcomes. Results will be shown as change from baseline to 24 month follow-up.
The visual analogue scale (VAS) is a commonly used outcome measure for research studies. It is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "0"/no pain at all" and "100/worst pain imaginable." The study in this scale is used for the worst arm pain. A lower score represents a better score.
Measured: 24 months
Clinical Outcomes: VAS Neck
Improvement of clinical outcomes (VAS Neck) for all enrolled patients. Improvement is a reduction of scores for all clinical outcomes. Results will be shown as change from baseline to 24 month follow-up.
The visual analogue scale (VAS) is a commonly used outcome measure for research studies. It is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "0"/no pain at all" and "100/worst pain imaginable." The study in this scale is used for neck pain. A lower score represents a better score.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start18 Nov 2018
- Primary completion15 Jun 2020
- Study completion30 Jan 2021 (estimated)
Why it stopped: Study halted prematurely and will not resume; participants are no longer receiving intervention due to coronavirus pandemic and unexpected enrollment delays.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disc Degeneration;CervicalStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- SeaSpine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Khalid Abbed, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871400
- Sponsor's protocol ID
- SS-NM-1801
- Status last verified
- Oct 2020
- First submitted
- 8 Mar 2019
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early Fusion Using a NanoMetalene® Implant Versus Both PEEK and Allograft Implants in Anterior Cervical Discectomy and Fusion (ACDF) With OsteoStrand™ Demineralized Bone Fibers
- ClinicalTrials.gov ID
- NCT03871400
- Acronym / sponsor ID
- SS-NM-1801
- Conditions
- Disc Degeneration;Cervical
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study halted prematurely and will not resume; participants are no longer receiving intervention due to coronavirus pandemic and unexpected enrollment delays.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- SeaSpine, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Nov 2018 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 30 Jan 2021 (estimated)
- First posted
- 12 Mar 2019 (actual)
- 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.
A prospective, multi-center, randomized, self-controlled, single-blinded, clinical study evaluating the NanoMetalene implant as compared to the PEEK and allograft implants in ACDF for the treatment of cervical degenerative disc disease (DDD).
Detailed description
PEEK: Polyetheretherketone ACDF: Anterior cervical discectomy and fusion
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NanoMetalene/PEEK | Other | Procedure: Anterior cervical discectomy and fusion |
| NanoMetalene/Allograft | Other | Procedure: Anterior cervical discectomy and fusion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cervical degenerative disc disease
- Requires primary spinal fusion from C3-C7
- Minimum of 6 weeks of non-operative treatment
- Signed informed consent form
Key exclusion criteria (12 listed)
- Uncontrolled type I or II diabetes mellitus
- Morbid obesity
- Documented history of alcohol or drug abuse
- Fever or leukocytosis
- Current systemic infection
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 |
|---|---|---|
| Anterior cervical discectomy and fusionprimary, 2-level, contiguous | Procedure or surgery | NanoMetalene/Allograft, NanoMetalene/PEEK |
Primary outcome
Proportion of cervical spinal levels for NanoMetalene vs PEEK interbody implants that have achieved fusion as determined by Computed Tomography (CT) analysis
Time frame: 12 months
Proportion of cervical spinal levels for NanoMetalene vs PEEK interbody implants that have achieved fusion as determined by Computed Tomography (CT) analysis
6 secondary outcomes
Secondary CT Analysis: PEEK
Time frame: 12 months
Secondary CT Analysis: Allograft
Time frame: 12 months
Secondary X-Ray Analysis
Time frame: 24 months
Clinical Outcomes: NDI
Time frame: 24 months
Clinical Outcomes: VAS Arm
Time frame: 24 months
Clinical Outcomes: VAS Neck
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Khalid Abbed, MD principal investigator
Yale University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior cervical discectomy and fusion in people with Disc Degeneration;Cervical, run by SeaSpine, Inc. at 11 sites 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 4 inclusion and 12 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: paused, as of the sponsor's last update on 19 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 11 sites 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?
Results are not available in the source record.
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?
Proportion of cervical spinal levels for NanoMetalene vs PEEK interbody implants that have achieved fusion as determined by Computed Tomography (CT) analysis (time frame: 12 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 19 Oct 2020.