SpondylolisthesisNCT02225444
A Prospective Study of Instrumented, Posterolateral Lumbar Fusions (PLF) With OsteoAMP®
An observational study of Spondylolisthesis and Scoliosis, run by Bioventus LLC at 9 sites in United States.
Trial summary
OsteoAMP is a novel allograft bone graft substitute (BGS) that has been processed to retain multiple endogenous growth factors for use in spinal fusion. The study is designed to obtain a higher level of clinical evidence for OsteoAMP in spinal fusion procedures and not to garner FDA regulatory approval. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Spondylolisthesis, Scoliosis, Intervertebral Disc Disease
- What is being tested?
- OsteoAMP
- How many people
- 42 participants
- Where
- 9 sitesUnited States
- Study dates
- 19 Nov 2015to 11 Oct 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients between 21 and 75 years old with degenerative disc disease, degenerative spondylolisthesis (up to grade 1), and/or mild degenerative scoliosis (up to 25° curvature) that have failed conservative treatment and are now indicated for instrumented posterolateral spinal fusion at 1 or 2 contiguous levels between L1-S1.
Summary of Inclusion Criteria:
- Aged 21 to 85 years and skeletally mature at time of surgery
- Diagnosis of degenerative disc disease (DDD), degenerative spondylolisthesis (up to grade 1), and/or mild degenerative scoliosis (up to 25°) curvature
- One or more of the following are met: -instability (defined a angulation greater than or equal to 5 degrees and/or translation greater than or equal 4mm based on flexion/extension radiographs, -osteophyte formation, - decreased disc height, - thickening of ligamentous tissue, disc degeneration or herniation,- facet joint degeneration
- Requires fusion (i.e., Symptomatic) at up to two contiguous levels from L1 to S1.
- Preoperative ODI score of more than 30
- Non-responsive to non-operative treatment for at least 6 months.
- Lower back pain with or without claudication.
- If of child-bearing potential, non-pregnant, non-nursing, and agrees to use contraception for up to 2 years following surgery
- Willing and able to comply with study plan and able to understand and sign informed consent
Summary of Exclusion Criteria
- Primary diagnosis of a spinal disorder other than DDD, degenerative spondylolisthesis up to Grade 1 or mild degenerative scoliosis of up to 25 degrees curvature
- Requires fusion of more than 2 vertebral levels or of 2 non-adjacent vertebral levels
- Conditions requiring medications that interfere with fusion or bone metabolism
- More than one immobile vertebral level between L1 and S1 from any cause
- Overt or active local or systemic infection, including latent infection around the surgical implantation site
- Clinically severe obesity as defined by the National Institutes of Health
- Uncontrolled diabetes mellitus as confirmed by HbA1c greater than 8%
- History of osteoporosis or other metabolic bone disorders, including Paget's disease and osteomalacia
- History of hypersensitivity to any of the agents used to process OsteoAMP
- History of autoimmune disease
- Received other bone graft substitutes
- Received medication that may interfere with fusion or bone metabolism within 2 weeks of planned surgery
- Received or plans to receive investigational therapy
- Presence of active malignancy unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of malignancy for at least 3 years
- Presence of systemic disease or condition, which affects his/her ability to participate in the study requirements or the ability to evaluate the efficacy of the product
- Prisoner, transient, or has been treated for chemical/alcohol dependency in an inpatient substance abuse program within 6 months prior to study enrollment or has significant psychosocial disturbance that would affect participation in the study, in the opinion of the investigator
- Any condition for which the surgical procedure, in the opinion of the Investigator, poses an undue risk
- Pursuing litigation related to cervical and/or lumbar/lumbosacral spine
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207
Rush University Medical Center
Chicago, Illinois, 60612
The Rothman Institute
Egg Harbor, New Jersey, 08234
Kansas University Medical School
Kansas City, Kansas, 66160
West Virginia University
Morgantown, West Virginia, 26506
Yale University
New Haven, Connecticut, 06511
Orthopedic Institute of Western KY
Paducah, Kentucky, 42001
William Beaumont
Royal Oak, Michigan, 48073
About this study
Official title: A Prospective Study of Instrumented, Posterolateral Lumbar Fusions (PLF) With OsteoAMP® to Evaluate Long-Term Safety and Efficacy in Patients Requiring 1-2 Level Instrumented PLF
OsteoAMP is a novel allograft bone graft substitute (BGS) that has been processed to retain multiple endogenous growth factors for use in spinal fusion. The study is designed to obtain a higher level of clinical evidence for OsteoAMP in spinal fusion procedures and not to garner FDA regulatory approval. This is a prospective, non-randomized, non-controlled, multi-center study of OsteoAMP in instrumented, posterolateral lumbar fusion (PLF) in patients with degenerative disc disease, degenerative spondylolisthesis (up to grade 1), and/or mild degenerative scoliosis, up to 25 degree curvature. Patients that are scheduled to undergo instrumented, posterolateral spinal fusion surgery as part of their medical treatment and comply with the study eligibility criteria will be given the opportunity to consent and be entered into the study.
Read the detailed description
The objective of this clinical study are: to evaluate the long term efficacy of OsteoAMP in patients requiring 1 to 2 adjacent level, instrumented posterolateral spinal fusion procedure of the lumbar or lumbosacral spine, and to evaluate OsteoAMP in spinal fusion procedures based on fusion results, adverse event rates, and pain and health scores.
Patients that are scheduled to undergo instrumented, posterolateral spinal fusion (PLF) surgery as part of their medical treatment and comply with the study eligibility criteria will be recruited and entered into the study. Subjects recruited into the study will receive OsteoAMP as part of an instrumented PLF surgical procedure. The surgery may also include nerve root decompressions through laminectomies and foraminotomies. As is consistent with the current standard of care.
The study involves consecutive patients suffering from lower back and leg pain due to degenerative disc disease (DDD), degenerative spondylolisthesis (up to grade 1), and/or mild degenerative scoliosis that are candidates for an instrumented PLF with pedicle screws in 1 or 2 motion segments of the lumbar or lumbosacral spine. Patients will require a total bone graft volume of at least 10cc per side per level in the PLF procedure, including OsteoAMP granules hydrated with bone marrow aspirate (BMA) and local autogenous bone.
Subjects will be followed for 24 months post-surgery.
- Conditions
- Spondylolisthesis, Scoliosis, Intervertebral Disc Disease
- Being tested
- OsteoAMP
- Keywords
- degenerative lumbosacral spine disease, posterolateral fusion evaluation, OsteoAMP, autograft
- Medical subject headings
- Spondylolisthesis, Scoliosis, Intervertebral disc disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteoAMPOther
OsteoAMP in posterolateral fusion procedure of the lumbosacral spine
| Study group | Role | What they receive |
|---|---|---|
| OsteoAMP treatment group | The OsteoAMP treatment group contains patients randomized to receive their own bone (retrieved from the surgical site) augmented with the OsteoAMP growth factor to assist with posterolateral arthrodesis at 1 or 2 adjacent levels between L1-S1. Receives: Other: OsteoAMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posterolateral fusion evaluation as determined by physician's assessment
Radiographic evidence of fusion assessed by flexion-extension and CT radiograph or computed tomography (CT) scans.
- Flexion extension radiographs timeframe: Pre-op, 6 month, 12 month, 24 months
- CT timeframe: 12 month, 24 month. NOTE: If subject determined to be fused at 12 months, 24 month x-rays and CT not required
Measured: 24 month follow up
Improvement form baseline low back pain
Improvement form baseline in low back pain and function as measured by Oswestry Disability Index (ODI)
Measured: 24 month follow up
Secondary outcomes (4)
Improvements in pain
Visual Analogue Scale (VAS) improvement from baseline to 24 month follow up assessed at timeframes: Pre-Op, 6 weeks, 3 month, 6 month, 12 month, 24 month
Measured: 24 month follow up
Improvements in function
Short Form 36 (SF-36) score improvement compared to baseline at 24 months assessed at timeframes: Pre-Op, 6 weeks, 3 month, 6 month, 12 month, 24 month
Measured: 24 month follow up
Posterolateral fusion as determined by independently scored and adjudicated assessment
Radiographic evidence of fusion assessed by flexion-extension and CT at 12 months and 24 months
Measured: 24 month follow up
Improvements in Other Health-Related Quality of Life measures
Health-Related Quality of Life measures; work status, use of medication and perception of treatment effectiveness at Weeks 6 Post- Surgery, 3 months, 6 months, 12 months and 24 months
Measured: 24 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study start19 Nov 2015
- Primary completion24 Jun 2019
- Study completion11 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylolisthesisStudies 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
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioventus LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- West Virginia University, Rush University Medical Center, University of Kansas
- Responsible party
- Sponsor
- Investigators
- Scott Daffner, MD, Principal investigator, West Virginia UniversityHoward An, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225444
- Sponsor's protocol ID
- TP1020
- Status last verified
- Nov 2020
- First submitted
- 22 Aug 2014
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Instrumented, Posterolateral Lumbar Fusions (PLF) With OsteoAMP® to Evaluate Long-Term Safety and Efficacy in Patients Requiring 1-2 Level Instrumented PLF
- ClinicalTrials.gov ID
- NCT02225444
- Acronym / sponsor ID
- TP1020
- Conditions
- Spondylolisthesis, Scoliosis, Intervertebral Disc Disease
- Keywords
- degenerative lumbosacral spine disease, posterolateral fusion evaluation, OsteoAMP, autograft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Bioventus LLCIndustry (pharma, biotech, devices)
- Collaborators
- West Virginia University, Rush University Medical Center, University of Kansas
- Study start
- 19 Nov 2015 (actual)
- Primary completion
- 24 Jun 2019 (actual)
- Study completion
- 11 Oct 2019 (actual)
- First posted
- 26 Aug 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.
OsteoAMP is a novel allograft bone graft substitute (BGS) that has been processed to retain multiple endogenous growth factors for use in spinal fusion. The study is designed to obtain a higher level of clinical evidence for OsteoAMP in spinal fusion procedures and not to garner FDA regulatory approval. This is a prospective, non-randomized, non-controlled, multi-center study of OsteoAMP in instrumented, posterolateral lumbar fusion (PLF) in patients with degenerative disc disease, degenerative spondylolisthesis (up to grade 1), and/or mild degenerative scoliosis, up to 25 degree curvature. Patients that are scheduled to undergo instrumented, posterolateral spinal fusion surgery as part of their medical treatment and comply with the study eligibility criteria will be given the opportunity to consent and be entered into the study.
Detailed description
The objective of this clinical study are: to evaluate the long term efficacy of OsteoAMP in patients requiring 1 to 2 adjacent level, instrumented posterolateral spinal fusion procedure of the lumbar or lumbosacral spine, and to evaluate OsteoAMP in spinal fusion procedures based on fusion results, adverse event rates, and pain and health scores.
Patients that are scheduled to undergo instrumented, posterolateral spinal fusion (PLF) surgery as part of their medical treatment and comply with the study eligibility criteria will be recruited and entered into the study. Subjects recruited into the study will receive OsteoAMP as part of an instrumented PLF surgical procedure. The surgery may also include nerve root decompressions through laminectomies and foraminotomies. As is consistent with the current standard of care.
The study involves consecutive patients suffering from lower back and leg pain due to degenerative disc disease (DDD), degenerative spondylolisthesis (up to grade 1), and/or mild degenerative scoliosis that are candidates for an instrumented PLF with pedicle screws in 1 or 2 motion segments of the lumbar or lumbosacral spine. Patients will require a total bone graft volume of at least 10cc per side per level in the PLF procedure, including OsteoAMP granules hydrated with bone marrow aspirate (BMA) and local autogenous bone.
Subjects will be followed for 24 months post-surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OsteoAMP treatment group | – | Other: OsteoAMPThe OsteoAMP treatment group contains patients randomized to receive their own bone (retrieved from the surgical site) augmented with the OsteoAMP growth factor to assist with posterolateral arthrodesis at 1 or 2 adjacent levels between L1-S1. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients between 21 and 75 years old with degenerative disc disease, degenerative spondylolisthesis (up to grade 1), and/or mild degenerative scoliosis (up to 25° curvature) that have failed conservative treatment and are now indicated for instrumented posterolateral spinal fusion at 1 or 2 contiguous levels between L1-S1.
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 |
|---|---|---|
| OsteoAMPOsteoAMP in posterolateral fusion procedure of the lumbosacral spine | Other | OsteoAMP treatment group |
Primary outcome
Posterolateral fusion evaluation as determined by physician's assessment
Time frame: 24 month follow up
Radiographic evidence of fusion assessed by flexion-extension and CT radiograph or computed tomography (CT) scans. * Flexion extension radiographs timeframe: Pre-op, 6 month, 12 month, 24 months * CT timeframe: 12 month, 24 month. NOTE: If subject determined to be fused at 12 months, 24 month x-rays and CT not required
Improvement form baseline low back pain
Time frame: 24 month follow up
Improvement form baseline in low back pain and function as measured by Oswestry Disability Index (ODI)
4 secondary outcomes
Improvements in pain
Time frame: 24 month follow up
Improvements in function
Time frame: 24 month follow up
Posterolateral fusion as determined by independently scored and adjudicated assessment
Time frame: 24 month follow up
Improvements in Other Health-Related Quality of Life measures
Time frame: 24 month follow up
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 5 Nov 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.
Scott Daffner, MD principal investigator
West Virginia University
Howard An, MD principal investigator
Rush University Medical Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondylolisthesis and Scoliosis, run by Bioventus LLC at 9 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?
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 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Posterolateral fusion evaluation as determined by physician's assessment (time frame: 24 month follow up). 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 5 Nov 2020.