Lumbar Spinal Stenosis Secondary to Other DiseaseNCT02005341
NanOss Bioactive With Autograft and Bone Marrow Aspirate in the Posterolateral Spine
A study testing nanOSS and Autograft in people with Lumbar Spinal Stenosis Secondary to Other Disease, run by Pioneer Surgical Technology, Inc..
Trial summary
The purpose of this study is to assess lumbar fusion using nanOss Bioactive bone void filler Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis Secondary to Other Disease
- What is being tested?
- nanOSS and Autograft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Sep 2014
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is at least 21 years of age and skeletally mature.
- Must have cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one level in the cervical spine between C3 to T1.
- Must have completed a minimum of six weeks of unsuccessful conservative, non-operative care or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment.
- Has pre-operative objective evidence of primary diagnosis confirmed by appropriate imaging studies (Anteroposterior/Lateral/Flexion/Extension X-rays \& a recent MRI).
- Is willing and able to comply with all clinical investigation visits and procedures including screening treatment procedures, post-operative management, the follow-up schedule and completion of forms or questionnaires.
- Is able to understand and sign the patient information sheet/informed consent form.
Who cannot join
- Requires fusion at more than one level.
- Has had prior fusion at the level to be treated.
- Has a metabolic or systemic bone disorder.
- Has a disease that significantly inhibits bone healing (i.e., severe osteoporosis, osteomalacia, Paget's disease).
- Has a systemic or local infection (active or latent).
- Has acute or chronic infections in the surgical area (i.e., soft tissue infections; inflammatory, bacterial bone disorders, osteomyelitis).
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- Chronic use of steroids, other than episodic use or inhaled corticosteroids.
- Has any significant general illness (i.e., HIV, active metastatic cancer of any type, uncontrolled diabetes Type I, dialysis dependent renal failure, symptomatic liver disease).
- Has a mental or physical condition that would limit the ability to comply with study requirements or would preclude accurate evaluation.
- Is immunocompromised or being treated with immunosuppressive agents (including chemotherapy or radiation treatment).
- Has documented allergies to hydroxyapatite or porcine collagen, PEEK, titanium, titanium alloy or tantalum.
- Is currently pregnant, or interested in becoming pregnant during the clinical investigation follow-up.
- Is a smoker.
- Is non-English speaking.
- Requires the use of a bone-growth stimulator.
- Is a prisoner.
- Is currently involved in another drug or device clinical investigation that may confound the clinical trial investigation
About this study
Official title: A Prospective, Nonrandomized Study to Assess Lumbar Fusion With Instrumented Posterolateral Gutter Fusions Using NanOss Bioactive
The purpose of this study is to assess lumbar fusion using nanOss Bioactive bone void filler
- Being tested
- nanOSS, Autograft
- Keywords
- Lumbar, fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nanOSSDevice
AutograftDevice
| Study group | Role | What they receive |
|---|---|---|
| Autograft bone | Active comparator | Not described Receives: Device: Autograft |
| nanOss with bone marrow aspirate | Experimental | Not described Receives: Device: nanOSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion at 12 months postoperatively.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startOct 2011
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Why it stopped: A change in research priorities after a merger
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal Stenosis Secondary to Other 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pioneer Surgical Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005341
- Sponsor's protocol ID
- 2010-02b
- Status last verified
- Jan 2017
- First submitted
- 3 Dec 2013
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Nonrandomized Study to Assess Lumbar Fusion With Instrumented Posterolateral Gutter Fusions Using NanOss Bioactive
- ClinicalTrials.gov ID
- NCT02005341
- Acronym / sponsor ID
- 2010-02b
- Keywords
- Lumbar, fusion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: A change in research priorities after a merger
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pioneer Surgical Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 9 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.
The purpose of this study is to assess lumbar fusion using nanOss Bioactive bone void filler
Study design
- Primary purpose
- Treatment
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autograft bone | Active comparator | Device: Autograft |
| nanOss with bone marrow aspirate | Experimental | Device: nanOSS |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Is at least 21 years of age and skeletally mature.
- Must have cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one level in the cervical spine between C3 to T1.
- Must have completed a minimum of six weeks of unsuccessful conservative, non-operative care or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment.
- Has pre-operative objective evidence of primary diagnosis confirmed by appropriate imaging studies (Anteroposterior/Lateral/Flexion/Extension X-rays \& a recent MRI).
- Is willing and able to comply with all clinical investigation visits and procedures including screening treatment procedures, post-operative management, the follow-up schedule and completion of forms or questionnaires.
Key exclusion criteria (17 listed)
- Requires fusion at more than one level.
- Has had prior fusion at the level to be treated.
- Has a metabolic or systemic bone disorder.
- Has a disease that significantly inhibits bone healing (i.e., severe osteoporosis, osteomalacia, Paget's disease).
- Has a systemic or local infection (active or latent).
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 |
|---|---|---|
| nanOSS | Device | nanOss with bone marrow aspirate |
| Autograft | Device | Autograft bone |
Primary outcome
Fusion at 12 months postoperatively.
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing nanOSS and Autograft in people with Lumbar Spinal Stenosis Secondary to Other Disease, run by Pioneer Surgical Technology, Inc..
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 6 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: withdrawn, as of the sponsor's last update on 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Fusion at 12 months postoperatively. (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 4 Jan 2017; AzTrials last refreshed its copy on 6 Nov 2026.