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

Scoliosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02225444
• Other study ID #: TP1020
• Status: Completed
• Start date: November 19, 2015
• Est. completion date: October 11, 2019

Study information

• Verified date: November 2020
• Source: Bioventus LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 11, 2019
• Est. primary completion date: June 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Intervertebral Disc Disease
• Scoliosis
• Spondylolisthesis

Intervention

Other:
• OsteoAMP
OsteoAMP in posterolateral fusion procedure of the lumbosacral spine

Locations

Country	Name	City	State
United States	St. Luke's University Health Network	Bethlehem	Pennsylvania
United States	OrthoCarolina Research Institute	Charlotte	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	The Rothman Institute	Egg Harbor Township	New Jersey
United States	Kansas University Medical School	Kansas City	Kansas
United States	West Virginia University	Morgantown	West Virginia
United States	Yale University	New Haven	Connecticut
United States	Orthopedic Institute of Western KY	Paducah	Kentucky
United States	William Beaumont	Royal Oak	Michigan

Sponsors (4)

Lead Sponsor	Collaborator
Bioventus LLC	Rush University Medical Center, University of Kansas, West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maintenance or improvement from baseline in neurological status with no new permanent deficits	Neurological exam	24 month follow up
Other	Absence of serious product-related adverse events	Serious product-related adverse events	24 month follow up
Other	Freedom from subsequent product-related surgical interventions	Interventions include revision, removal, re-operation, and supplemental fixation at the affected level(s)	24 month follow up
Primary	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
Primary	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	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	24 month follow up
Secondary	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	24 month follow up
Secondary	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	24 month follow up
Secondary	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	24 month follow up