Degenerative Disc DiseaseNCT01968993
Comparison of nanOss Bioactive With Autograft and Bone Marrow Aspirate to Autograft in the Posterolateral Spine
A study testing nanOss Bioactive - posterolateral gutter in people with Degenerative Disc Disease and Spinal Stenosis, run by Pioneer Surgical Technology, Inc. at 3 sites in United States.
Trial summary
nanOss Bioactive is approved for use in the U.S. The purpose of this study is to compare fusion results in the posterolateral spine using nanOss Bioactive mixed with autograft bone and bone marrow aspirate (BMA) on one side and autograft alone on the opposite side of the treated level(s). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis
- What is being tested?
- nanOss Bioactive - posterolateral gutter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2010to Oct 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- is at least 18 years of age and skeletally mature.
- must have symptomatic spinal stenosis and/or spondylolisthesis or degenerative disc disease (DDD) at one or two adjacent levels from L2-S1 requiring a fusion.
- must have completed a minimum of three months of unsuccessful conservative, non-operative care.
- must have discogenic back pain with or without leg pain.
- DDD must be confirmed by MRI or CT scans followed by discography (if necessary).
- must score at least 40% on the Oswestry Disability Index.
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- must score at least a 4 on a 10 cm Visual Analog Scale for back pain.
- must be able to comply with the protocol's follow-up schedule.
- must understand and sign the informed consent document.
Who cannot join
- symptomatic at more than 2 levels.
- previous fusion surgery at any lumbar level with or without instrumentation (prior discectomy, laminotomy, laminectomy or nucleolysis at the operative (involved) level > 6 months is permitted).
- more than 50% spondylolisthesis.
- lumbar scoliosis greater than 11 degrees.
- osteoporosis, osteopenia, osteomalacia, Paget's disease or metabolic bone disease.
- spinal tumors.
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- active arachnoiditis.
- fractures of the epiphyseal plate or fractures for which stabilization of the fracture is not possible.
- impaired calcium metabolism.
- active infection or surgical site infection.
- rheumatoid arthritis or other autoimmune disease
- chronic steroid use (used steroids for one month within the last 6 months) or any medical condition that requires treatment with drugs known to interfere with bone healing.
- systemic disease such as AIDS, HIV, hepatitis (active), tuberculosis.
- morbid obesity defined as body mass index (BMI)>40 or a weight more than 100lbs over ideal body weight.
- smokers unless the patient agrees to quit at least 2 weeks prior to and for the duration of the study, confirmed by a carboxyhemoglobin test prior to surgery.
- psychosocial disorders that would preclude accurate evaluation or has a history of substance abuse.
- active malignancy except non-melanoma skin cancer; history of any invasive malignancy unless treated and in remission for at least five years.
- documented allergies to porcine collagen or titanium
- pregnancy, or interested in becoming pregnant in the next four years.
- participation in another investigational study within 30 days.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Columbia Orthopedic Group
Columbia, Missouri, 65201
Scripps Green Hospital
La Jolla, California, 92037
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: A Prospective, Nonrandomized Study to Assess Lumbar Fusion Using Interbody Cages With Autograft in Conjunction With Instrumented Posterolateral Gutter Fusions Using nanOss Bioactive and Autograft Bone.
nanOss Bioactive is approved for use in the U.S. The purpose of this study is to compare fusion results in the posterolateral spine using nanOss Bioactive mixed with autograft bone and bone marrow aspirate (BMA) on one side and autograft alone on the opposite side of the treated level(s). It is hypothesized that the use of nanOss Bioactive will result in fusion at 12 months, with CT evidence of bridging trabecular bone, less than 3mm of translational motion, and less than 5 degrees of angular motion.
Read the detailed description
The post market clinical investigation is designed to assess instrumented posterolateral fusion (PLF) using nanOss Bioactive bone void filler with autograft bone and bone marrow aspirate in patients with symptomatic spinal stenosis secondary to degenerative disc disease with up to Grade 1 spondylolisthesis at one or two adjacent levels from L2-S1.
Preoperatively, the participant will provide his/her medical history and complete self assessment forms. The investigator will perform a clinical evaluation and x-rays will be performed if recent x-rays are not available. Participants will undergo instrumented PLF with an interbody fusion device (with autograft or allograft) using nanOss Bioactive in combination with autograft bone and bone marrow aspirate in one posterolateral gutter and autograft alone in the opposite posterolateral gutter.
Following surgery, operative and discharge information will be collected and a clinical evaluation will be performed prior to discharge. Participants will be evaluated 6 and 12 months postoperatively. One investigational site will participate in long-term followup of 24 months. Each participant will complete x-rays and self assessment documents. A CT scan performed at the 12 month postoperative visit will be evaluated by an independent radiologist to assess fusion results. Complication data will be recorded throughout the study.
- Being tested
- nanOss Bioactive - posterolateral gutter
- Keywords
- Degenerative Disc Disease
- Medical subject headings
- Intervertebral Disc Degeneration, Spinal Stenosis, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nanOss Bioactive - posterolateral gutterDevice
Participants will undergo instrumented PLF at one or two adjacent levels from L2-S1 with PEEK interbody cages (containing allograft or autograft) using nanOss Bioactive in combination with autograft and bone marrow aspirate in the posterolateral gutter on one side. Autograft alone will be used in the opposite posterolateral gutter.
| Study group | Role | What they receive |
|---|---|---|
| nanOss Bioactive - posterolateral gutter | Experimental | Participants will undergo instrumented PLF at one or two adjacent levels from L2-S1 with PEEK interbody cages (containing allograft or autograft) using nanOss Bioactive in combination with autograft and bone marrow aspirate in the posterolateral gutter on one side. Autograft alone will be used in the opposite posterolateral gutter. Receives: Device: nanOss Bioactive - posterolateral gutter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion
Based on x-ray and CT scan. Defined as bridging trabecular bone and less than 3mm of translational motion and less than 5mm of angular motion. X-rays obtained at 6 months and 12 months. CT obtained at 12 months.
Measured: 12 months
Secondary outcomes (6)
Improvement in Oswestry Disability Index score
As compared to baseline levels
Measured: Preoperatively, 6 months, 12 months
Improvement in VAS pain scores
As compared to baseline levels.
Measured: Preoperatively, 6 months, 12 months
Improvement in Short Form-36 scores (SF-36)
As compared to baseline levels.
Measured: Preoperatively, 6 months, 12 months
Decrease in medication usage
As compared to baseline levels.
Measured: Preoperatively, 6 months, 12 months
Work status
As compared to baseline levels.
Measured: Preoperatively, 6 months, 12 months
Patient satisfaction
As compared to baseline levels.
Measured: Preoperatively, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study startJan 2010
- Primary completionOct 2015
- Study completionOct 2015
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pioneer Surgical Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Eastlack, MD, Principal investigator, Scripps Green HospitalThomas Highland, MD, Principal investigator, Columbia Orthopedic Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968993
- Sponsor's protocol ID
- 2010-02
- Status last verified
- Nov 2016
- First submitted
- 21 Oct 2013
- Last updated
- 8 Nov 2016
- 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 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Nonrandomized Study to Assess Lumbar Fusion Using Interbody Cages With Autograft in Conjunction With Instrumented Posterolateral Gutter Fusions Using nanOss Bioactive and Autograft Bone.
- ClinicalTrials.gov ID
- NCT01968993
- Acronym / sponsor ID
- 2010-02
- Keywords
- Degenerative Disc Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Pioneer Surgical Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 24 Oct 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.
nanOss Bioactive is approved for use in the U.S. The purpose of this study is to compare fusion results in the posterolateral spine using nanOss Bioactive mixed with autograft bone and bone marrow aspirate (BMA) on one side and autograft alone on the opposite side of the treated level(s). It is hypothesized that the use of nanOss Bioactive will result in fusion at 12 months, with CT evidence of bridging trabecular bone, less than 3mm of translational motion, and less than 5 degrees of angular motion.
Detailed description
The post market clinical investigation is designed to assess instrumented posterolateral fusion (PLF) using nanOss Bioactive bone void filler with autograft bone and bone marrow aspirate in patients with symptomatic spinal stenosis secondary to degenerative disc disease with up to Grade 1 spondylolisthesis at one or two adjacent levels from L2-S1.
Preoperatively, the participant will provide his/her medical history and complete self assessment forms. The investigator will perform a clinical evaluation and x-rays will be performed if recent x-rays are not available. Participants will undergo instrumented PLF with an interbody fusion device (with autograft or allograft) using nanOss Bioactive in combination with autograft bone and bone marrow aspirate in one posterolateral gutter and autograft alone in the opposite posterolateral gutter.
Following surgery, operative and discharge information will be collected and a clinical evaluation will be performed prior to discharge. Participants will be evaluated 6 and 12 months postoperatively. One investigational site will participate in long-term followup of 24 months. Each participant will complete x-rays and self assessment documents. A CT scan performed at the 12 month postoperative visit will be evaluated by an independent radiologist to assess fusion results. Complication data will be recorded throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nanOss Bioactive - posterolateral gutter | Experimental | Device: nanOss Bioactive - posterolateral gutterParticipants will undergo instrumented PLF at one or two adjacent levels from L2-S1 with PEEK interbody cages (containing allograft or autograft) using nanOss Bioactive in combination with autograft and bone marrow aspirate in the posterolateral gutter on one side. Autograft alone will be used in the opposite posterolateral gutter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- is at least 18 years of age and skeletally mature.
- must have symptomatic spinal stenosis and/or spondylolisthesis or degenerative disc disease (DDD) at one or two adjacent levels from L2-S1 requiring a fusion.
- must have completed a minimum of three months of unsuccessful conservative, non-operative care.
- must have discogenic back pain with or without leg pain.
- DDD must be confirmed by MRI or CT scans followed by discography (if necessary).
Key exclusion criteria (20 listed)
- symptomatic at more than 2 levels.
- previous fusion surgery at any lumbar level with or without instrumentation (prior discectomy, laminotomy, laminectomy or nucleolysis at the operative (involved) level > 6 months is permitted).
- more than 50% spondylolisthesis.
- lumbar scoliosis greater than 11 degrees.
- osteoporosis, osteopenia, osteomalacia, Paget's disease or metabolic bone disease.
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 Bioactive - posterolateral gutterParticipants will undergo instrumented PLF at one or two adjacent levels from L2-S1 with PEEK interbody cages (containing allograft or autograft) using nanOss Bioactive in combination with autograft and bone marrow aspirate in the posterolateral gutter on one side. Autograft alone will be used in the opposite posterolateral gutter. | Device | nanOss Bioactive - posterolateral gutter |
Primary outcome
Fusion
Time frame: 12 months
Based on x-ray and CT scan. Defined as bridging trabecular bone and less than 3mm of translational motion and less than 5mm of angular motion. X-rays obtained at 6 months and 12 months. CT obtained at 12 months.
6 secondary outcomes
Improvement in Oswestry Disability Index score
Time frame: Preoperatively, 6 months, 12 months
Improvement in VAS pain scores
Time frame: Preoperatively, 6 months, 12 months
Improvement in Short Form-36 scores (SF-36)
Time frame: Preoperatively, 6 months, 12 months
Decrease in medication usage
Time frame: Preoperatively, 6 months, 12 months
Work status
Time frame: Preoperatively, 6 months, 12 months
Patient satisfaction
Time frame: Preoperatively, 6 months, 12 months
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 8 Nov 2016.
- 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.
Robert Eastlack, MD principal investigator
Scripps Green Hospital
Thomas Highland, MD principal investigator
Columbia Orthopedic Group
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nanOss Bioactive - posterolateral gutter in people with Degenerative Disc Disease and Spinal Stenosis, run by Pioneer Surgical Technology, Inc. at 3 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 9 inclusion and 20 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 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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?
Fusion (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 8 Nov 2016.