Randomized Study of Anular Repair With the Xclose Tissue Repair System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anulex Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00760799
First received: September 25, 2008
Last updated: May 1, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Diskectomy
Procedure: Discectomy with anular repair
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Study of Anular Repair With the Xclose Tissue Repair System

Resource links provided by NLM:


Further study details as provided by Anulex Technologies, Inc.:

Primary Outcome Measures:
  • Re-operations due to re-herniation (repeat discectomy procedure) [ Time Frame: 2 wks and at 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient outcomes (utilizing Oswestry Disability Index, Visual Analog Scale and SF-12 quality of life assessment), Health care utilization, Return to work [ Time Frame: 2 weeks and at 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]

Enrollment: 750
Study Start Date: March 2007
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Repair of the anulus fibrosus following discectomy.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00760799

  Show 34 Study Locations
Sponsors and Collaborators
Anulex Technologies, Inc.
  More Information

No publications provided by Anulex Technologies, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anulex Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00760799     History of Changes
Other Study ID Numbers: 06101_B
Study First Received: September 25, 2008
Last Updated: May 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Anulex Technologies, Inc.:
Lumbar Disc Herniation

ClinicalTrials.gov processed this record on April 17, 2014