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A Prospective Study of Instrumented, Posterolateral Lumbar Fusions (PLF) With OsteoAMP®

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02225444
Recruitment Status : Completed
First Posted : August 26, 2014
Last Update Posted : November 5, 2020
Sponsor:
Collaborators:
West Virginia University
Rush University Medical Center
University of Kansas
Information provided by (Responsible Party):
Bioventus LLC

Study Description
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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.

Condition or disease Intervention/treatment
Spondylolisthesis Scoliosis Intervertebral Disc Disease Other: OsteoAMP

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
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Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : November 19, 2015
Actual Primary Completion Date : June 24, 2019
Actual Study Completion Date : October 11, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Other: OsteoAMP
OsteoAMP in posterolateral fusion procedure of the lumbosacral spine


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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)


Secondary Outcome Measures :
  1. Improvements in pain [ Time Frame: 24 month follow up ]
    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

  2. Improvements in function [ Time Frame: 24 month follow up ]
    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

  3. Posterolateral fusion as determined by independently scored and adjudicated assessment [ Time Frame: 24 month follow up ]
    Radiographic evidence of fusion assessed by flexion-extension and CT at 12 months and 24 months

  4. Improvements in Other Health-Related Quality of Life measures [ Time Frame: 24 month follow up ]
    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


Other Outcome Measures:
  1. Maintenance or improvement from baseline in neurological status with no new permanent deficits [ Time Frame: 24 month follow up ]
    Neurological exam

  2. Absence of serious product-related adverse events [ Time Frame: 24 month follow up ]
    Serious product-related adverse events

  3. Freedom from subsequent product-related surgical interventions [ Time Frame: 24 month follow up ]
    Interventions include revision, removal, re-operation, and supplemental fixation at the affected level(s)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Summary of Inclusion Criteria:

  1. Aged 21 to 85 years and skeletally mature at time of surgery
  2. Diagnosis of degenerative disc disease (DDD), degenerative spondylolisthesis (up to grade 1), and/or mild degenerative scoliosis (up to 25°) curvature
  3. 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
  4. Requires fusion (i.e., Symptomatic) at up to two contiguous levels from L1 to S1.
  5. Preoperative ODI score of more than 30
  6. Non-responsive to non-operative treatment for at least 6 months.
  7. Lower back pain with or without claudication.
  8. If of child-bearing potential, non-pregnant, non-nursing, and agrees to use contraception for up to 2 years following surgery
  9. Willing and able to comply with study plan and able to understand and sign informed consent

Summary of Exclusion Criteria

  1. 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
  2. Requires fusion of more than 2 vertebral levels or of 2 non-adjacent vertebral levels
  3. Conditions requiring medications that interfere with fusion or bone metabolism
  4. More than one immobile vertebral level between L1 and S1 from any cause
  5. Overt or active local or systemic infection, including latent infection around the surgical implantation site
  6. Clinically severe obesity as defined by the National Institutes of Health
  7. Uncontrolled diabetes mellitus as confirmed by HbA1c greater than 8%
  8. History of osteoporosis or other metabolic bone disorders, including Paget's disease and osteomalacia
  9. History of hypersensitivity to any of the agents used to process OsteoAMP
  10. History of autoimmune disease
  11. Received other bone graft substitutes
  12. Received medication that may interfere with fusion or bone metabolism within 2 weeks of planned surgery
  13. Received or plans to receive investigational therapy
  14. 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
  15. 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
  16. 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
  17. Any condition for which the surgical procedure, in the opinion of the Investigator, poses an undue risk
  18. Pursuing litigation related to cervical and/or lumbar/lumbosacral spine
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02225444


Locations
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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06511
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Kansas
Kansas University Medical School
Kansas City, Kansas, United States, 66160
United States, Kentucky
Orthopedic Institute of Western KY
Paducah, Kentucky, United States, 42001
United States, Michigan
William Beaumont
Royal Oak, Michigan, United States, 48073
United States, New Jersey
The Rothman Institute
Egg Harbor Township, New Jersey, United States, 08234
United States, North Carolina
OrthoCarolina Research Institute
Charlotte, North Carolina, United States, 28207
United States, Pennsylvania
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States, 18015
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Bioventus LLC
West Virginia University
Rush University Medical Center
University of Kansas
Investigators
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Principal Investigator: Scott Daffner, MD West Virginia University
Principal Investigator: Howard An, MD Rush University Medical Center
More Information
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Responsible Party: Bioventus LLC
ClinicalTrials.gov Identifier: NCT02225444    
Other Study ID Numbers: TP1020
First Posted: August 26, 2014    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Keywords provided by Bioventus LLC:
degenerative lumbosacral spine disease
posterolateral fusion evaluation
OsteoAMP
autograft
Additional relevant MeSH terms:
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Scoliosis
Spondylolisthesis
Spinal Curvatures
Spinal Diseases
 Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis