A Prospective Study of Instrumented, Posterolateral Lumbar Fusions (PLF) With OsteoAMP®
1 other identifier
observational
42
1 country
9
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2015
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2014
CompletedFirst Posted
Study publicly available on registry
August 26, 2014
CompletedStudy Start
First participant enrolled
November 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 11, 2019
CompletedNovember 5, 2020
November 1, 2020
3.6 years
August 22, 2014
November 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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)
24 month follow up
Secondary Outcomes (4)
Improvements in pain
24 month follow up
Improvements in function
24 month follow up
Posterolateral fusion as determined by independently scored and adjudicated assessment
24 month follow up
Improvements in Other Health-Related Quality of Life measures
24 month follow up
Other Outcomes (3)
Maintenance or improvement from baseline in neurological status with no new permanent deficits
24 month follow up
Absence of serious product-related adverse events
24 month follow up
Freedom from subsequent product-related surgical interventions
24 month follow up
Study Arms (1)
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.
Interventions
OsteoAMP in posterolateral fusion procedure of the lumbosacral spine
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bioventus LLClead
- West Virginia Universitycollaborator
- Rush University Medical Centercollaborator
- University of Kansascollaborator
Study Sites (9)
Yale University
New Haven, Connecticut, 06511, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Kansas University Medical School
Kansas City, Kansas, 66160, United States
Orthopedic Institute of Western KY
Paducah, Kentucky, 42001, United States
William Beaumont
Royal Oak, Michigan, 48073, United States
The Rothman Institute
Egg Harbor, New Jersey, 08234, United States
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Daffner, MD
West Virginia University
- PRINCIPAL INVESTIGATOR
Howard An, MD
Rush University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2014
First Posted
August 26, 2014
Study Start
November 19, 2015
Primary Completion
June 24, 2019
Study Completion
October 11, 2019
Last Updated
November 5, 2020
Record last verified: 2020-11