ClinicalTrials.gov
ClinicalTrials.gov Menu

DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00387829
Recruitment Status : Terminated (Sponsor voluntarily terminated study)
First Posted : October 13, 2006
Results First Posted : November 20, 2013
Last Update Posted : September 7, 2017
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Spinal Injuries Adhesions Device: DuraGen Plus Adhesion Barrier Matrix Not Applicable

Detailed Description:
For more information, please visit www.DuragenStudy.com

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 347 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of DuraGen Plus® Adhesion Barrier Matrix to Minimize Adhesions Following Lumbar Discectomy
Study Start Date : October 2006
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions
U.S. FDA Resources

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Radiological, Pain, and Functional Outcome Assessments [ Time Frame: 6 months ]

    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 :
  1. Radiological, Pain, and Functional Outcome Assessments [ Time Frame: 12 months ]

    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.




Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00387829


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

Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT00387829     History of Changes
Other Study ID Numbers: DURA-US-2006-1
First Posted: October 13, 2006    Key Record Dates
Results First Posted: November 20, 2013
Last Update Posted: September 7, 2017
Last Verified: August 2017

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