Status:
COMPLETED
A Prospective Study of Instrumented, Posterolateral Lumbar Fusions (PLF) With OsteoAMP®
Lead Sponsor:
Bioventus LLC
Collaborating Sponsors:
West Virginia University
Rush University Medical Center
Conditions:
Spondylolisthesis
Scoliosis
Eligibility:
All Genders
21-85 years
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 19 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 11 2019
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT02225444
Start Date
November 19 2015
End Date
October 11 2019
Last Update
November 5 2020
Active Locations (9)
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1
Yale University
New Haven, Connecticut, United States, 06511
2
Rush University Medical Center
Chicago, Illinois, United States, 60612
3
Kansas University Medical School
Kansas City, Kansas, United States, 66160
4
Orthopedic Institute of Western KY
Paducah, Kentucky, United States, 42001