DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery

This study has been terminated.
(Sponsor voluntarily terminated study)
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Corporation
ClinicalTrials.gov Identifier:
NCT00387829
First received: October 12, 2006
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

To evaluate the safety and effectiveness of DuraGen Plus® Adhesion Barrier Matrix as an adhesion barrier in spinal surgery to reduce the extent of peridural fibrosis formation and radicular pain in comparison to a control group receiving standard care.


Condition Intervention
Spinal Injuries
Adhesions
Device: DuraGen Plus Adhesion Barrier Matrix

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of DuraGen Plus® Adhesion Barrier Matrix to Minimize Adhesions Following Lumbar Discectomy

Resource links provided by NLM:


Further study details as provided by Integra LifeSciences Corporation:

Primary Outcome Measures:
  • Radiological, Pain, and Functional Outcome Assessments [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Radiological score (MRI Outcome score): MRI peridural fibrosis in 5 consecutive 2-D axial Spin Echo T1 axial slices. Score consists of the ratio of total available space in each image and the amount of scar identified (percentage).

    Pain (VAS): Visual Analog Score used to rate the subject's pain.VAS scale is a 100 mm horizontal line, where the far left side of the scale equals (0) no pain and the far right side of the scale (100) equals the worst possible pain.

    Functional outcome score (ODI): Used to assess the effect leg or back pain on everyday life. Questions relate to areas such as walking, lifting, sitting, ability to travel as well as other common activities. Ten questions with scores from 0-5. Calculated as percentage: (Actual score /Maximum overall score (worst disability))*100.



Secondary Outcome Measures:
  • Radiological, Pain, and Functional Outcome Assessments [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    Radiological score (MRI Outcome score): MRI peridural fibrosis in 5 consecutive 2-D axial Spin Echo T1 axial slices. Score consists of the ratio of total available space in each image and the amount of scar identified (percentage).

    Pain (VAS): Visual Analog Score used to rate the subject's pain.VAS scale is a 100 mm horizontal line, where the far left side of the scale equals (0) no pain and the far right side of the scale (100) equals the worst possible pain.

    Functional outcome score (ODI): Used to assess the effect leg or back pain on everyday life. Questions relate to areas such as walking, lifting, sitting, ability to travel as well as other common activities. Ten questions with scores from 0-5. Calculated as percentage: (Actual score /Maximum overall score (worst disability))*100.



Enrollment: 347
Study Start Date: October 2006
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
Device: DuraGen Plus Adhesion Barrier Matrix
Application of DuraGen Plus Adhesion Barrier Matrix in spine surgery
No Intervention: 2
Control arm is surgery alone (no adhesion barrier)

Detailed Description:

For more information, please visit www.DuragenStudy.com

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (Abstracted from clinical protocol):

  • Patients with radicular pain requiring single-level, lumbar hemi-laminectomy or hemilaminotomy procedures with discectomy in the lower lumbar spine
  • Require initial open lumbar surgery for extruded, prolapsed or bulging intervertebral discs
  • Requires removal of herniated disc fragment

Exclusion Criteria (Abstracted from clinical protocol):

  • Current or historic open traumatic injury to the spine
  • Any previous surgery to the lumbar spine or percutaneous tissue destruction or ablation procedures
  • Women who are nursing, women who are pregnant and women who are planning to become pregnant during the time of the study
  • Any spinal conditions or systemic diseases that would preclude the patient from participation in the clinical trial
  • Clinically significant structural disorders
  • Known positive for HIV
  • Insulin-dependent Diabetes Mellitus patients
  • Morbid obesity (Body Mass Index greater than or equal to 40 kg/m2)
  • History of alcohol or drug abuse within 2 years prior to randomization
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00387829

  Show 36 Study Locations
Sponsors and Collaborators
Integra LifeSciences Corporation
Investigators
Principal Investigator: Edward Benzel, MD The Cleveland Clinic Spine Institute
  More Information

No publications provided

Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT00387829     History of Changes
Other Study ID Numbers: DURA-US-2006-1
Study First Received: October 12, 2006
Results First Received: June 7, 2013
Last Updated: September 17, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Spinal Injuries
Tissue Adhesions
Back Injuries
Cicatrix
Fibrosis
Pathologic Processes
Wounds and Injuries
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Polyestradiol phosphate
Contraceptive Agents
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014