Degenerative Disc DiseaseNCT01452516
Effectiveness of Lumbar Fusion When NanOss Bioactive Is Used With Posterolateral Gutter Fusions
A study testing nanOss Bioactive Bone void filler and Interbody FCage in people with Degenerative Disc Disease and Spinal Stenosis, run by Pioneer Surgical Technology, Inc. at 7 sites in United States.
Trial summary
Spine fusion is one of the most common procedures performed in spinal surgery. Several surgical techniques can achieve a solid union, but the intertransverse posterolateral fusion (PLF) is the most widely used. 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 Bone void filler and Interbody FCage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 7 sitesUnited States
- Study dates
- Jul 2010to Sep 2013
- 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
- The patient can be included in the study if all of the following criteria are met;
- 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)
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- must score at least 40 points on the Oswestry Disability Index
- 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
- The patient must not exhibit any of the following criteria;
- symptomatic at more than two 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.
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- spinal tumors
- active arachnoiditis Pioneer Surgical Technology Confidential nanOss Bioactive Post Marketing Clinical Study: March 11, 2010 Page 8
- 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 100 lbs 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 *Osteoporosis will be assessed at the time of the preoperative evaluation based on the patient"s history, physical examination and review of the radiographic evaluations. All patients at risk for osteoporosis must obtain a DEXA scan of the spine and hip to determine if the patient has severe osteoporosis. The definition of a patient at risk used by the National Osteoporosis Foundation includes the following: i. Premature menopause (< 45 years) ii. Prolonged amenorrhea (> one year) iii. Maternal history of hip fracture iv. Primary hyperparathyroidism or hyperthyroidism v. Chronic renal failure vi. Previous fragility fractures, particularly of the hip, spine or wrist vii. Patients who have ever taken corticosteroids in doses >7.5 mg/day for one year or more. Patients will be excluded if their bone mineral density (BMD) in the spine or hip is more than 1.0 standard deviation (SD) below the mean of normal adults in the presence of one or more fragility fractures indicating severe osteoporosis. If severe osteoporosis is diagnosed, the patient must be excluded from the investigational study. If the patient has osteoporosis or osteopenia, they may be included in the study if he or she meets the rest of the inclusion and exclusion criteria.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Tower Orthopaedics & Neurosurgical Spine Institute
Beverly Hills, California, 90048
Medical University of South Carolina Neurology
Charleston, South Carolina, 29425
Northwestern Medical Facility
Chicago, Illinois, 60611
Scripps Memorial Hospital Neurosurgery
La Jolla, California, 92037
Advanced Center for Orthopedics
Marquette, Michigan, 49855
Milwaukee Spinal Specialists
Milwaukee, Wisconsin, 53211
St. Johns Spine and Pain Clinic
Springfield, Missouri, 65804
About this study
Official title: A Prospective, Multi-Center, Nonrandomized Study to Assess Lumbar Fusion Using Interbody Cages With Autograft in Conjunction With Instrumented Posterolateral Gutter Fusions Using NanOss Bioactive
Spine fusion is one of the most common procedures performed in spinal surgery. Several surgical techniques can achieve a solid union, but the intertransverse posterolateral fusion (PLF) is the most widely used. However, complications can develop when the bone graft material used is insufficient to achieve the desired fusion. With its unique properties, nanOss Bioactive can be mixed with bone marrow aspirate (BMA) and other graft materials to obtain new bone growth during the healing process.
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. In addition, patients are expected to see an improvement in Oswestry Disability Index scores, VAS pain scores, and SF36 scores, while decreasing the use of pain medication, returning to work, and finding satisfaction in the results of their surgery.
Read the detailed description
The post marketing clinical trial is designed to assess lumbar fusion using interbody cages with autograft in conjunction with instrumented posterolateral gutter fusions using nanOss Bioactive bone void filler in patients with degenerative disc disease (DDD) characterized by the inclusion and exclusion criteria listed below.
Patients for this study will be recruited from up to 10 clinical sites. It is estimated that 100 patients will be enrolled in the study. At least 10 investigators will participate in the study. Patients who meet the inclusion and exclusion criteria will be asked to sign the informed consent. Preoperatively, the patient will provide his /her medical history and complete self assessment forms. The investigator will perform a clinical evaluation.
Patients who meet the criteria for entrance into the study will undergo lumbar fusion using interbody cages with autograft in conjunction with instrumented posterolateral gutter fusions using nanOss Bioactive in combination with local autograft and bone marrow aspirate (BMA). Anterior lumbar interbody fusion procedures are not allowed.
Following surgery, operative and discharge information will be collected. The patients will be evaluated at 6 weeks, 6 months and 12 months postoperatively. At each postoperative visit, the investigator will clinically evaluate the patient and the patient will complete self assessment documents, Oswestry Disability Index, Quality of Life questionnaires and a surgery satisfaction survey, e.g., very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied with the surgery. Fusion status will be evaluated radiographically at each visit using plain films. CT scans at 12 months will be evaluated by an independent radiologist. Complication data will be recorded throughout the study.
- Being tested
- nanOss Bioactive Bone void filler, Interbody FCage
- Keywords
- PLF, lumbar fusion, bone graft, biologics
- 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 Bone void fillerDevice
Instrumented posterolateral gutter fusions using nanOss Bioactive bone void filler
Interbody FCageDevice
Lumbar fusion using interbody cages with autograft. This will be done in conjunction with the posterolatreal gutter fusion
| Study group | Role | What they receive |
|---|---|---|
| nanOss Bioactive Bone void filler | Other | Lumbar fusion using interbody cages with autograft in conjunction with instrumented posterolateral gutter fusions using nanOss Bioactive bone void filler Receives: Device: nanOss Bioactive Bone void filler; Device: Interbody FCage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal fusion
- Bridging trabecular bone
- Less than 3mm of translational motion
- Less than 5mm of angular motion
Measured: 12 months
Secondary outcomes (6)
Improvement in Oswestry Disability Index score
Measured: 12 months
Improvement in VAS pain scores
Measured: 12 months
Improvement in Quality of Life scores
Measured: 12 months
Decrease in medication usage
Measured: 12 months
Patient returning to work
Measured: 12 months
Patient satisfaction (surgery satisfaction survey, e.g., very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied with the surgery)
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 posted17 Oct 2011 (estimated)
- Study startJul 2010
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: Study was terminated due to slow accrual rate.
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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pioneer Surgical Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mathew Songer, MD, Principal investigator, Advanced Center for Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452516
- Sponsor's protocol ID
- B01-2010
- Status last verified
- Nov 2016
- First submitted
- 2 Sep 2011
- Last updated
- 7 Dec 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 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Nonrandomized Study to Assess Lumbar Fusion Using Interbody Cages With Autograft in Conjunction With Instrumented Posterolateral Gutter Fusions Using NanOss Bioactive
- ClinicalTrials.gov ID
- NCT01452516
- Acronym / sponsor ID
- B01-2010
- Keywords
- PLF, lumbar fusion, bone graft, biologics
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to slow accrual rate.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Pioneer Surgical Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 17 Oct 2011 (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.
Spine fusion is one of the most common procedures performed in spinal surgery. Several surgical techniques can achieve a solid union, but the intertransverse posterolateral fusion (PLF) is the most widely used. However, complications can develop when the bone graft material used is insufficient to achieve the desired fusion. With its unique properties, nanOss Bioactive can be mixed with bone marrow aspirate (BMA) and other graft materials to obtain new bone growth during the healing process.
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. In addition, patients are expected to see an improvement in Oswestry Disability Index scores, VAS pain scores, and SF36 scores, while decreasing the use of pain medication, returning to work, and finding satisfaction in the results of their surgery.
Detailed description
The post marketing clinical trial is designed to assess lumbar fusion using interbody cages with autograft in conjunction with instrumented posterolateral gutter fusions using nanOss Bioactive bone void filler in patients with degenerative disc disease (DDD) characterized by the inclusion and exclusion criteria listed below.
Patients for this study will be recruited from up to 10 clinical sites. It is estimated that 100 patients will be enrolled in the study. At least 10 investigators will participate in the study. Patients who meet the inclusion and exclusion criteria will be asked to sign the informed consent. Preoperatively, the patient will provide his /her medical history and complete self assessment forms. The investigator will perform a clinical evaluation.
Patients who meet the criteria for entrance into the study will undergo lumbar fusion using interbody cages with autograft in conjunction with instrumented posterolateral gutter fusions using nanOss Bioactive in combination with local autograft and bone marrow aspirate (BMA). Anterior lumbar interbody fusion procedures are not allowed.
Following surgery, operative and discharge information will be collected. The patients will be evaluated at 6 weeks, 6 months and 12 months postoperatively. At each postoperative visit, the investigator will clinically evaluate the patient and the patient will complete self assessment documents, Oswestry Disability Index, Quality of Life questionnaires and a surgery satisfaction survey, e.g., very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied with the surgery. Fusion status will be evaluated radiographically at each visit using plain films. CT scans at 12 months will be evaluated by an independent radiologist. 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 Bone void filler | Other | Device: nanOss Bioactive Bone void filler, Device: Interbody FCageLumbar fusion using interbody cages with autograft in conjunction with instrumented posterolateral gutter fusions using nanOss Bioactive bone void filler |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The patient can be included in the study if all of the following criteria are met;
- 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
Key exclusion criteria (21 listed)
- The patient must not exhibit any of the following criteria;
- symptomatic at more than two 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
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 Bone void fillerInstrumented posterolateral gutter fusions using nanOss Bioactive bone void filler | Device | nanOss Bioactive Bone void filler |
| Interbody FCageLumbar fusion using interbody cages with autograft. This will be done in conjunction with the posterolatreal gutter fusion | Device | nanOss Bioactive Bone void filler |
Primary outcome
Spinal fusion
Time frame: 12 months
1. Bridging trabecular bone 2. Less than 3mm of translational motion 3. Less than 5mm of angular motion
6 secondary outcomes
Improvement in Oswestry Disability Index score
Time frame: 12 months
Improvement in VAS pain scores
Time frame: 12 months
Improvement in Quality of Life scores
Time frame: 12 months
Decrease in medication usage
Time frame: 12 months
Patient returning to work
Time frame: 12 months
Patient satisfaction (surgery satisfaction survey, e.g., very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied with the surgery)
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Study was terminated due to slow accrual rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 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.
Mathew Songer, MD principal investigator
Advanced Center for Orthopedics
7 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 Bone void filler and Interbody FCage in people with Degenerative Disc Disease and Spinal Stenosis, run by Pioneer Surgical Technology, Inc. at 7 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 10 inclusion and 21 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: stopped early, as of the sponsor's last update on 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 was stopped early (reason given: Study was terminated due to slow accrual rate.). 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?
Spinal 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 7 Dec 2016.