Biostat System

Clinical trial for the nonsurgical treatment of chronic low back pain.

Introduction

The Biostat® System study is a medical research study of an investigational nonsurgical procedure for those who have chronic low back pain associated with internal disc disruption (IDD).In IDD it is believed that low back pain is caused by the development of tears or cracks inside the rubbery discs between the bones of the spine. Pain from IDD is mostly located in the lower back, but may also include the hips, buttocks, groin or thighs. The pain associated with IDD is referred to as “discogenic pain”, since it originates from the disc itself. Researchers have shown that approximately 40% of chronic low back pain is caused by IDD.

How the Biostat® System works

This study will evaluate the effectiveness and safety of the study procedure, which is an investigational nonsurgical method using the Biostat® Delivery Device to inject a substance called BIOSTAT BIOLOGX Fibrin Sealant to fill the tears and cracks contained within a spinal disc in the lower back. The application of fibrin sealant to the disc may alleviate pain by sealing the painful disruptions, reducing inflammation, and enhancing tissue repair.

Study objectives

The purpose of the study is to evaluate 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.

Study overview

The study will be conducted at up to 15 investigational centers in the United States in up to 260 subjects with chronic low back pain where medications, physical therapy or spinal injections have had limited or no success.

All qualified study participants receive study-related procedures and office visits including medical evaluations at no charge. In addition, compensation may also be available for qualified participants.

Patients who participate in the study will have a 3 in 4 chance of receiving the active investigational procedure and a 1 in 4 chance of receiving a placebo (inactive substance). Neither the patient nor the study doctor will be able to choose which substance will be used. The selection process will be randomly determined. No matter which substance is received, the procedure and follow-up visits will be the same.

Patients that qualify for this study may be asked to participate up to 18-months. During this period patients may be asked to come in for follow-up visits after 1-week, 4-weeks, 13-weeks, 26-weeks, 39-weeks, 52-weeks, and 78-weeks.

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Study sponsor

Spinal Restoration, Inc.

Status

Recruiting

Who can participate in the Biostat® System Study?

Subjects must meet all of the inclusion criteria and none of the exclusion criteria. Some of the major inclusion/exclusion criteria are listed below:

Inclusion criteria

To qualify patients must:

• Be an adult at least 18 years of age
• Have experienced low back pain for at least the past 6 months
• NOT have leg pain (when present):
• a) That occurs below the knee
• or
• b) Is greater than their back pain
• Have low back pain which persists even though they have had at least 3 months of conservative care, such as:
• Chiropractic care
• Best rest
• Acupuncture
• Massage
• Physical therapy
• Exercise
• Lower back injections
• Pain or anti-inflammatory medications

Exclusion criteria

Patients MAY NOT be eligible to participate in this study if they:

• Have had previous lower back surgery
• Have a ruptured or herniated disc, sciatica, spinal stenosis, or spondylolisthesis (a slipped disc)
• Have tingling or numbness in their lower legs.

There are additional inclusion/exclusion criteria. Only a doctor participating in the Biostat study will be able to determine if a patient meets all of the inclusion criteria and none of the exclusion criteria, and thus, is eligible to be a study participant.

Participating sites

• Alabama - Birmingham
• Arizona - Phoenix
• California - Santa Monica
• Delaware - Wilmington
• Florida - Merritt Island
• Illinois - Bloomington
• Minnesota - Edina
• Mississippi - Flowood
• North Carolina - Charlotte
• Ohio - Columbus
• Texas - Tyler
• Virginia - Richmond
• Washington - Bellingham

Interested in participating?

You or someone you know may be eligible to participate in this study.

To see if you may qualify for participation in this clinical study, please take this short survey.

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Caution: Investigational New Drug. Limited by Federal (United States) law to investigational use.