Randomized Study of Anular Repair With the Xclose Tissue Repair System

The purpose of this study is to evaluate the benefits of anulus fibrosus repair utilizing Xclose™ compared to a discectomy without anulus fibrosus repair.

Study Overview

• Status: Completed
• Conditions: Diskectomy
• Intervention / Treatment: Procedure: Discectomy with anular repair

Detailed Description

Discectomy surgery is intended to remove the impinging fragment on the nerve root thus alleviating the pain and providing the nerve with a better healing environment. Discectomy procedures entail removing a bony portion of the vertebral body to access the posterior side of the disc space, and then removing the impinging fragment from the disc. The fragment being removed can either be contained within the wall of the anulus, which requires incision into the anulus to remove it, or it could be extruded through an anular fissure. In the absence of a safe and easy method to close or seal the defect in the anulus following a discectomy procedure, surgeons are left with no alternative but to leave the anulus in this compromised state which is largely the current practice. This rent in the soft tissue of the anulus fibrosus can lead to postoperative problems if the remaining nuclear tissue in the disc pushes through the anular defect or incision causing recurrent or persistent pain.

Initial studies involved the placement of sutures to seal the anular defect. This work strongly suggested that microsurgical anular reconstruction can reduce recurrent herniations and re-operations, post discectomy. Unfortunately, this technique is not easy to perform and may pose an increased risk to the patient.

This study utilizes the Xclose™ Tissue Repair System to re-approximate the compromised tissue of the anulus fibrosus in appropriately randomized patients in an effort to quantify the benefits of anular repair for discectomy patients.

• Study Type: Interventional
• Enrollment (Actual): 750
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • North Alabama Neurological, P.A.
  • Arizona
    • Phoenix, Arizona, United States, 85020
      • Desert Institute for Spine Care
    • Phoenix, Arizona, United States, 85015
      • Texas Back Institute
  • California
    • San Diego, California, United States, 92103
      • University of California San Diego
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
      • Denver Spine (Porter Hospital)
    • Greenwood Village, Colorado, United States, 80111
      • Denver Spine (Presbyterian/St. Luke's Hospital)
  • Florida
    • Gainesville, Florida, United States, 32605
      • North Florida Regional Hospital
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
    • Jacksonville, Florida, United States, 32207
      • Lyerly Neurosurgical (Baptist Health)
    • Jacksonville, Florida, United States, 32256
      • Lyerly Neurosurgical (Centerone)
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Midwest Orthopaedics at Rush
    • Chicago, Illinois, United States, 60640
      • Chicago Institute of Neurosurgery and Neuroresearch
    • Palos Heights, Illinois, United States, 60463
      • Palos Community Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Indiana Spine Group
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Heartland Spine
  • Massachusetts
    • Boston, Massachusetts, United States, 02120
      • New England Baptist
  • Michigan
    • Dearborn, Michigan, United States, 48124
      • Oakwood Hospital
    • Detroit, Michigan, United States, 48202
      • Henry Ford
  • Minnesota
    • Sartell, Minnesota, United States, 56377
      • Central Minnesota Neurosciences
  • Nebraska
    • Omaha, Nebraska, United States, 68198-2035
      • University of Nebraska Medical Center
  • New York
    • Suffern, New York, United States, 10901
      • Hudson Valley Neurosurgical Associates
  • North Carolina
    • Raleigh, North Carolina, United States, 27609
      • Capital Neurosurgery
    • Wilmington, North Carolina, United States, 28401-7593
      • Atlantic Neurosurgical & Spine
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17109
      • Pennsylvania Spine Institute
    • Pittsburgh, Pennsylvania, United States, 15232
      • West Penn Neurosurgery Group
  • Rhode Island
    • North Providence, Rhode Island, United States, 02904
      • Our Lady of Fatima Hospital
  • Tennessee
    • Johnson City, Tennessee, United States, 37604
      • East Tennessee Brain and Spine
  • Texas
    • Plano, Texas, United States, 75093
      • Texas Back Institute
    • San Antonio, Texas, United States, 75216
      • San Antonio Orthopedic Group
    • San Antonio, Texas, United States, 75258
      • South Texas Spine Clinic
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin
  • Wyoming
    • Cheyenne, Wyoming, United States, 82009
      • Wyoming Spine and Neurosurgery Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Candidate for a one or two level discectomy
• Positive imaging evidence of intervertebral disc herniation at location corresponding to patient's radicular signs or symptoms
• Anular tear or slit incision and additionally deemed to include sufficient tissue for tissue reapproximation
• Persistent and predominant radicular pain
• Pre-operative leg pain score > 4.0 cm on a 10 cm Visual Analog Scale (VAS)
• Leg pain unresponsive to conservative treatment (physical therapy and non-steroidal anti-inflammatory medical therapy) for 6 or more weeks; exception, individuals suffering from acute and uncontrollable severe leg pain
• Patient is willing and able to comply with study requirements; willing and able to sign a study-specific, informed consent form, complete necessary study paperwork and return for required follow-up visits.

Exclusion Criteria:

• Age less than 18 years
• Prior or planned surgical procedure intended to fuse or stabilize the lumbar spine
• Previous surgery involving index level
• Cauda Equina Syndrome
• Evidence of severe disc degeneration
• Greater than Grade I spondylolisthesis or retrolisthesis at the affected level
• No apparent anular defect and no indication to open the anulus at time of procedure
• Active local or systemic infection
• Active malignancy or other significant medical co-morbidities
• Current chemical dependency or significant emotional and/or psychosocial disturbance that would impact treatment outcome or study participation
• Patient or legal guardians who are unwilling or unable to cooperate or give written informed consent
• Women who are pregnant or with child bearing potential and who are not on a reliable form of birth control
• Current fracture, tumor and/or deformity (> 15° of lumbar scoliosis, using Cobb measuring technique) of the spine
• Documented history of allergy or intolerance to PET
• Patient is currently enrolled in other research that could confound the results of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 1; Standard discectomy without anular repair	Procedure: Discectomy with anular repair; Comparison of discectomy with and without repair to the anulus fibrosus of the intervertebral disc; Other Names: Repair of the anulus fibrosus following discectomy.
EXPERIMENTAL: 2; Standard Discectomy with anular repair	Procedure: Discectomy with anular repair; Comparison of discectomy with and without repair to the anulus fibrosus of the intervertebral disc; Other Names: Repair of the anulus fibrosus following discectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Re-operations due to re-herniation (repeat discectomy procedure)	2 wks and at 6, 12, 18 and 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient outcomes (utilizing Oswestry Disability Index, Visual Analog Scale and SF-12 quality of life assessment), Health care utilization, Return to work	2 weeks and at 6, 12, 18, and 24 months

Collaborators and Investigators

• Sponsor: Anulex Technologies, Inc.

Publications and helpful links

General Publications

• Bailey A, Araghi A, Blumenthal S, Huffmon GV; Anular Repair Clinical Study Group. Prospective, multicenter, randomized, controlled study of anular repair in lumbar discectomy: two-year follow-up. Spine (Phila Pa 1976). 2013 Jun 15;38(14):1161-9. doi: 10.1097/BRS.0b013e31828b2e2f. Erratum In: Spine (Phila Pa 1976). 2013 Aug 1;38(17):1527.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): January 1, 2012

Study Registration Dates

• First Submitted: September 25, 2008
• First Submitted That Met QC Criteria: September 25, 2008
• First Posted (ESTIMATE): September 26, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): May 2, 2012
• Last Update Submitted That Met QC Criteria: May 1, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Lumbar Disc Herniation
• Other Study ID Numbers: 06101_B