Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System

NCT ID: NCT01011816

Last Updated: 2014-05-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2013-05-31

Brief Summary

The purpose of this investigation is to establish the safety and efficacy of the Biostat System when used for treatment of chronic low back (lumbar) pain due to symptomatic internal disc disruptions (IDD) by comparing safety and efficacy outcome measures between one group receiving BIOSTAT BIOLOGX® Fibrin Sealant through the Biostat® Delivery Device and another group receiving a preservative-free normal saline control delivered with the Biostat Delivery Device.

Detailed Description

The Biostat System is a combination product combining a resorbable biologic product with a delivery device system used to prepare and insert the biologic material into a lumbar intervertebral disc.

Symptomatic IDD is defined as a painful disruption of the internal architecture of a lumbar intervertebral disc, which appears as fissures, cracks or tears within the internal structures of the disc. Pain arising from a lumbar disc may not only be perceived as pain located in the low back (axial pain) but also as somatic referred pain involving the posterior hips, buttocks, lateral hips, groin, or posterior thighs.

The diagnosis of symptomatic IDD cannot currently be made on the basis of imaging studies, physical examination, or symptoms alone, and is best established with meticulously conducted disc provocation studies (provocation discography) that include pressure manometry and identification of an adjacent normal disc.

This treatment and study are not designed for patients exhibiting other potential sources of chronic low back pain such as more advanced degenerative disc disease with significant loss of disc height (>33%), spinal stenosis, or spondylolisthesis (see Eligibility Criteria).

Conditions

Back Pain; Chronic Low Back Pain; Internal Disc Disruption; Degenerative Disc Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BIOSTAT BIOLOGX

One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc

Group Type: EXPERIMENTAL

BIOSTAT BIOLOGX

Intervention Type: BIOLOGICAL

One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device

Saline

One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

One injection of up to 4 mL of saline using the Biostat Delivery Device

Interventions

BIOSTAT BIOLOGX

One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device

Intervention Type: BIOLOGICAL

Saline

One injection of up to 4 mL of saline using the Biostat Delivery Device

Intervention Type: DRUG

Other Intervention Names

Fibrin Sealant; 0.9% w/v Sodium Chloride Injection, USP

Eligibility Criteria

Inclusion Criteria

• Age 18 or older and skeletally mature.
• Voluntarily signs the subject informed consent form and agrees to the release of medical information for purposes of this study (HIPAA authorization).
• Physically and mentally able to comply with the protocol, including ability to read and complete required forms, and willing and able to adhere to the follow-up requirements of the protocol.
• Chronic low back pain for at least 6 months.
• Pretreatment baseline low back pain of at least 40 mm on a 100 mm visual analog scale.
• Pretreatment baseline Roland-Morris Disability Questionnaire score of at least 9 on the 24-point questionnaire.
• Leg pain, if present, is of nonradicular origin, i.e., not due to stimulation of nerve roots or dorsal root ganglion of a spinal nerve by compressive forces.
• Leg pain, if present, does not extend below the knee and is no greater than 50% of low back pain as measured on a visual analog scale. If bilateral leg pain, the worst leg pain is no greater than 50% of low back pain.
• Low back pain unresponsive to at least 3 months of nonoperative care, which may include bed rest, antiinflammatory and analgesic medications, chiropractic manipulations, acupuncture, massage, physical therapy or home-directed lumbar exercise program.
• Diagnostic medial branch block or facet joint injection between 18 months and 2 weeks prior to the study procedure indicates no facet joint involvement.
• Diagnosis of symptomatic lumbar (L1-L2 - L5-S1) internal disc disruption (IDD), which requires confirmation of discogenic pain at one or two contiguous levels through positive provocation discography performed between 18 months and 2 weeks prior to the study procedure using pressure manometry and identification of an adjacent nonpainful disc. The disc provocation studies must precisely demonstrate concordant pain (<50 psi above opening pressure) and must demonstrate a fissure(s) in the outer one-third of the posterior or lateral anulus.

Exclusion Criteria

• Cauda equina syndrome.
• Active malignancy or tumor as source of symptoms.
• Current infection or prior history of spinal infection (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection.
• Previous lumbar spine surgery.
• Evidence of prior lumbar vertebral body fracture.
• Disc bulge/protrusion or focal herniation at the symptomatic level(s) > 4 mm.
• Presence of disc extrusion or sequestration.
• Leg pain is greater than 50% of low back pain as measured on a visual analog scale.
• Leg pain that extends below the knee.
• Lumbar intervertebral foramen stenosis at the affected level(s) resulting in significant spinal nerve root compression (effacement of the majority of periganglion fat and loss of CSF signal around the nerve rootlets).
• Symptomatic central vertebral canal stenosis or absolute sagittal vertebral canal diameter < 9mm.
• Loss of disc space height at the symptomatic level(s) greater than one-third of an adjacent normal disc (or of the expected height in the case of an L5-S1 disc).
• Spondylolisthesis (> Grade 1) with or without spondylolysis at the symptomatic level(s).
• Lumbar spondylitis or other undifferentiated spondyloarthropathy.
• Dynamic instability at the symptomatic level(s) on lumbar flexion-extension radiographs indicated by >4.5 mm of translation or angular motion >15° at L1-L2, L2-L3, or L3-L4; >20° at L4-L5; or >25° at L5-S1.
• Diagnostic medial branch block or facet joint injection indicate facet joint involvement.
• Diagnostic sacroiliac injection indicates sacroiliac joint involvement for those patients with pain in the sacral region.
• Sustained relief (>3 months) of low back pain obtained with epidural injection of corticosteroids.
• Symptomatic involvement of more than two lumbar disc levels determined from discography.
• Neurological examination shows findings of radiculopathy or a significant underlying neurological condition (motor strength <4; sensory assessment abnormal; or reflexes absent or hyperactive with clonus).
• Prior thermal intradiscal procedure (e.g., intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation).
• Any lumbar intradiscal injection procedure other than discography (e.g., injection of corticosteroids, methylene blue, dextrose, or glucosamine and chondroitin sulfate).
• Significant systemic disease, including unstable angina, autoimmune disease, rheumatoid arthritis, and muscular dystrophy.
• Congenital or acquired coagulopathy or thrombocytopenia; or currently taking anticoagulant, antineoplastic, antiplatelet, or thrombocytopenia-inducing medications; or undergoing radiation therapy.
• History of unexplained, easy, or persistent bruising or bleeding, bleeding from the gums, or bleeding problems experienced in previous surgical procedures.
• Aspirin or aspirin-containing medication taken ≤ 7 days prior to the procedure.
• Known or suspected hypersensitivity or allergy to drugs or components of the fibrin sealant (fibrinogen, thrombin, aprotinin, CaCl2) used in the procedure.
• History of, or current psychiatric or psychological condition, or substance or alcohol abuse that would potentially interfere with the subject's participation in the study.
• Ongoing or previous participation in another drug or device clinical study within the previous 2 months.
• Subject known to be pregnant or nursing at time of enrollment or with plans to become pregnant within the planned length of follow-up.
• Body habitus precludes adequate fluoroscopic visualization for the procedure or the procedure is physically impossible using the device.
• Concomitant conditions requiring daily oral steroid use for more than 30 days in the preceding 90 days.
• Pending litigation against a health care professional, except where required by the insurer as a condition of coverage, personal injury compensation or litigation claims.
• Prisoner or active military personnel who would not be available for follow-up.
• Presence of ferromagnetic implants that would disallow MRI of the symptomatic disc(s).
• Active or pending workers' compensation claims.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spinal Restoration, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin J Pauza, MD

Role: PRINCIPAL_INVESTIGATOR

Spine Specialists PA

Locations

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, United States

HOPE Research Institute

Phoenix, Arizona, United States

Pain Control Associates of San Diego

Chula Vista, California, United States

Napa Pain Institute

Napa, California, United States

California Spine Diagnostics

San Francisco, California, United States

The Spine Institute

Santa Monica, California, United States

The Pain Institute, Inc

Merritt Island, Florida, United States

Millennium Pain Center

Bloomington, Illinois, United States

The Spine Center

Baltimore, Maryland, United States

Medical Advanced Pain Specialists Applied Research Center

Edina, Minnesota, United States

NewSouth NeuroSpine Pain Center

Flowood, Mississippi, United States

OrthoCarolina Spine Center

Charlotte, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

OrthoNeuro, Inc.

New Albany, Ohio, United States

Allegheny Pain Management

Altoona, Pennsylvania, United States

Orthopaedic & Spine Specialists

York, Pennsylvania, United States

Spine Specialists PA

Tyler, Texas, United States

Virginia Spine Research Institute

Richmond, Virginia, United States

Advanced Pain Management

Virginia Beach, Virginia, United States

Bellingham Spine Pain Specialists PS

Bellingham, Washington, United States

Countries

United States

References

Yin W, Pauza K, Olan WJ, Doerzbacher JF, Thorne KJ. Intradiscal injection of fibrin sealant for the treatment of symptomatic lumbar internal disc disruption: results of a prospective multicenter pilot study with 24-month follow-up. Pain Med. 2014 Jan;15(1):16-31. doi: 10.1111/pme.12249. Epub 2013 Oct 23.

Reference Type: BACKGROUND

PMID: 24152079 (View on PubMed)

Buser Z, Keulling F, Jane L, Liebenberg E, Tang J, Thorne K, Coughlin D, Lotz J. Fibrin injection stimulates early disc healing in the porcine model [NASS Abstract 199]. Spine Journal 9:105S, 2009.

Reference Type: BACKGROUND

Buser Z, Kuelling F, Liu J, Liebenberg E, Thorne KJ, Coughlin D, Lotz JC. Biological and biomechanical effects of fibrin injection into porcine intervertebral discs. Spine (Phila Pa 1976). 2011 Aug 15;36(18):E1201-9. doi: 10.1097/BRS.0b013e31820566b2.

Reference Type: BACKGROUND

PMID: 21325992 (View on PubMed)

Pauza K, Yin W, Olan W, Doerzbacher JF. BIOSTAT BIOLOGX(R) intradiscal fibrin sealant used for treatment of chronic low back pain caused by lumbar disc disruption: results of a 12 month, prospective multicenter pilot study. Spine Arthroplasty Society Meeting, April 27-30, 2010; New Orleans, LA. Abstract 248.

Reference Type: BACKGROUND

Yin W, Pauza K, Olan W, Doerzbacher JF. Long-term outcomes from a prospective, multicenter investigational device exemption (IDE) pilot study of intradiscal fibrin sealant for the treatment of discogenic pain [ISIS Abstract]. Pain Medicine 12:1446-1447, 2011

Reference Type: BACKGROUND

Buser Z, Liu J, Thorne KJ, Coughlin D, Lotz JC. Inflammatory response of intervertebral disc cells is reduced by fibrin sealant scaffold in vitro. J Tissue Eng Regen Med. 2014 Jan;8(1):77-84. doi: 10.1002/term.1503. Epub 2012 May 18.

Reference Type: BACKGROUND

PMID: 22610998 (View on PubMed)

Other Identifiers

SR-BX01-2007

Identifier Type: -

Identifier Source: org_study_id