Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® Disc Augmentation System: A Pilot Study

NCT00693784 | Completed Results DMC

• 1 other identifier: SR-BX01P-2007
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to assess the safety of the Biostat Disc Augmentation System for the treatment of chronic low-back (lumbar) pain due to symptomatic internal disc disruptions (IDD) and to obtain preliminary efficacy information.

Conditions

Low Back Pain

Keywords

Intervertebral Disk; chronic low back pain; internal disc disruption; degenerative disc disease

Outcome Measures

Primary Outcomes (1)

• Numbers and Types of Adverse Events (Only Number of Events is Reported in This Section - See Adverse Events Section for Further Detail)

  The primary outcome for this safety study includes the number and types of adverse events reported in the study. The data fields in this section do not allow for reporting all aspects of this outcome (i.e., the number of adverse events, as well as the types of event). These numbers were entered and are reported in the adverse event section of the Results.

  104 weeks

Secondary Outcomes (2)

• Visual Analog Scale for Low-back Pain

  Baseline, 26-weeks (primary endpoint), 52-weeks, 104-weeks

• Roland-Morris Disability Questionnaire

  Baseline, 26-weeks (primary endpoint), 52-weeks, 104-weeks

Study Arms (1)

Biostat® Disc Augmentation System

EXPERIMENTAL

Delivery of Biostat BIOLOGX® Fibrin Sealant with the Biostat Delivery Device

Biological: Biostat® Disc Augmentation System

Interventions

Biostat® Disc Augmentation System BIOLOGICAL

Delivery of Biostat BIOLOGX® Fibrin Sealant with the Biostat Delivery Device

Biostat® Disc Augmentation System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 (inclusive) 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.
• 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.
• Referred leg pain, if present, is of noncompressive origin and there are no clinical findings of radiculopathy.
• Low-back pain is greater than leg pain (if present) as measured on a visual analog scale. If bilateral leg pain, back pain is greater than worst leg pain.
• Low-back pain unresponsive to at least 6 weeks of nonoperative treatment, which may include bed rest, antiinflammatory and analgesic medications, chiropractic manipulations, acupuncture, massage, physical therapy or home-directed lumbar exercise program.
• Negative response to diagnostic medial branch block or facet joint injection.
• No sustained relief with epidural injection of corticosteroids.
• 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 using pressure manometry and identification of an adjacent normal 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.
• Infection at the planned procedure site or active systemic infection.
• Previous lumbar spine surgery.
• Previous disc invasive treatment procedures at the affected level(s) (e.g., intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation) in the past 12 months or intradiscal corticosteroid injection within the past 3 months.
• Evidence of prior lumbar vertebral body fracture or trauma.
• Disc bulge/protrusion at the symptomatic level(s) \> 4 mm.
• Presence of disc extrusion or sequestration.
• Clinical findings of lumbosacral motor or sensory radiculopathy.
• Leg pain is greater than low-back pain as measured on a visual analog scale.
• Lumbar intervertebral foramen stenosis at the affected level(s) resulting in significant spinal nerve root compression or impingement.
• 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.

Sponsors & Collaborators

• Spinal Restoration, Inc.: lead

Study Sites (3)

Unknown Facility

Bethesda, Maryland, 20814, United States

Location

Unknown Facility

Tyler, Texas, 75701, United States

Location

Unknown Facility

Bellingham, Washington, 98226, United States

Location

MeSH Terms

Conditions

Low Back Pain; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jeff F. Doerzbacher
• Organization: Spinal Restoration, Inc.

jeffdoerzbacher@spinalrestoration.com

512 225-0405

Study Officials

• Kevin J Pauza, MD

  Spine Specialists, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2008
• First Posted: June 9, 2008
• Study Start: June 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: January 1, 2011
• Last Updated: June 22, 2015
• Results First Posted: April 29, 2010

Record last verified: 2015-05

Locations

US (3)