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

NCT ID: NCT02225444

Last Updated: 2020-11-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-19
• Study Completion Date: 2019-10-11

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

OsteoAMP

Intervention Type: OTHER

OsteoAMP in posterolateral fusion procedure of the lumbosacral spine

Interventions

OsteoAMP

OsteoAMP in posterolateral fusion procedure of the lumbosacral spine

Intervention Type: OTHER

Eligibility Criteria

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

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West Virginia University

OTHER

Sponsor Role: collaborator

Rush University Medical Center

OTHER

Sponsor Role: collaborator

University of Kansas

OTHER

Sponsor Role: collaborator

Bioventus LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Daffner, MD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Howard An, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

Yale University

New Haven, Connecticut, United States

Rush University Medical Center

Chicago, Illinois, United States

Kansas University Medical School

Kansas City, Kansas, United States

Orthopedic Institute of Western KY

Paducah, Kentucky, United States

William Beaumont

Royal Oak, Michigan, United States

The Rothman Institute

Egg Harbor, New Jersey, United States

OrthoCarolina Research Institute

Charlotte, North Carolina, United States

St. Luke's University Health Network

Bethlehem, Pennsylvania, United States

West Virginia University

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

TP1020

Identifier Type: -

Identifier Source: org_study_id