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

NCT01011816 | Terminated Phase 3 Results DMC

• 1 other identifier: SR-BX01-2007
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 20

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.

Conditions

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

Keywords

intervertebral disk

Outcome Measures

Primary Outcomes (1)

• Subject Composite Success

  Subject success based on a composite of minimum 30% decrease in low back pain, 30% improvement in function, maintenance of neurological status, no secondary interventions, and no serious adverse events.

  26 weeks

Secondary Outcomes (2)

• Visual Analog Scale for Low Back Pain

  26-weeks

• Roland-Morris Disability Questionnaire Score

  26-weeks

Study Arms (2)

BIOSTAT BIOLOGX

EXPERIMENTAL

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

Biological: BIOSTAT BIOLOGX

Saline

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

BIOSTAT BIOLOGX BIOLOGICAL

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

Also known as: Fibrin Sealant

BIOSTAT BIOLOGX

Saline DRUG

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

Also known as: 0.9% w/v Sodium Chloride Injection, USP

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spinal Restoration, Inc.: lead

Study Sites (20)

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 35235, United States

Location

HOPE Research Institute

Phoenix, Arizona, 85050, United States

Location

Pain Control Associates of San Diego

Chula Vista, California, 91914, United States

Location

Napa Pain Institute

Napa, California, 94559, United States

Location

California Spine Diagnostics

San Francisco, California, 94115, United States

Location

The Spine Institute

Santa Monica, California, 90403, United States

Location

The Pain Institute, Inc

Merritt Island, Florida, 32953, United States

Location

Millennium Pain Center

Bloomington, Illinois, 61701, United States

Location

The Spine Center

Baltimore, Maryland, 21211, United States

Location

Medical Advanced Pain Specialists Applied Research Center

Edina, Minnesota, 55435, United States

Location

NewSouth NeuroSpine Pain Center

Flowood, Mississippi, 39232, United States

Location

OrthoCarolina Spine Center

Charlotte, North Carolina, 28207, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

OrthoNeuro, Inc.

New Albany, Ohio, 43054, United States

Location

Allegheny Pain Management

Altoona, Pennsylvania, 16602, United States

Location

Orthopaedic & Spine Specialists

York, Pennsylvania, 17402, United States

Location

Spine Specialists PA

Tyler, Texas, 75701, United States

Location

Virginia Spine Research Institute

Richmond, Virginia, 23235, United States

Location

Advanced Pain Management

Virginia Beach, Virginia, 23454, United States

Location

Bellingham Spine Pain Specialists PS

Bellingham, Washington, 98226, United States

Location

Related Publications (6)

• 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.

  PMID: 24152079 BACKGROUND

• 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.

  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.

  PMID: 21325992 BACKGROUND

• 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.

  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

  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.

  PMID: 22610998 BACKGROUND

MeSH Terms

Conditions

Back Pain; Intervertebral Disc Degeneration

Interventions

Fibrin Tissue Adhesive; Sodium Chloride

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Jeff Doerzbacher
• Organization: formerly Spinal Restoration, Inc

jdoerzbacher@renascentmed.com

Study Officials

• Kevin J Pauza, MD

  Spine Specialists PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2009
• First Posted: November 11, 2009
• Study Start: March 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: May 1, 2013
• Last Updated: May 16, 2014
• Results First Posted: May 5, 2014

Record last verified: 2014-05

Locations

US (20)