Randomized Study of Anular Repair With the Xclose Tissue Repair System

Diskectomy Clinical Trial

Official title:

Randomized Study of Anular Repair With the Xclose Tissue Repair System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00760799
• Other study ID #: 06101_B
• Status: Completed
• Phase: Phase 4
• First received: September 25, 2008
• Last updated: May 1, 2012
• Start date: March 2007
• Est. completion date: January 2012

Study information

• Verified date: May 2012
• Source: Anulex Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diskectomy

Intervention

Procedure:
• Discectomy with anular repair
Comparison of discectomy with and without repair to the anulus fibrosus of the intervertebral disc

Locations

Country	Name	City	State
United States	New England Baptist	Boston	Massachusetts
United States	Wyoming Spine and Neurosurgery Associates	Cheyenne	Wyoming
United States	Chicago Institute of Neurosurgery and Neuroresearch	Chicago	Illinois
United States	Midwest Orthopaedics at Rush	Chicago	Illinois
United States	Oakwood Hospital	Dearborn	Michigan
United States	Henry Ford	Detroit	Michigan
United States	North Florida Regional Hospital	Gainesville	Florida
United States	Denver Spine (Porter Hospital)	Greenwood Village	Colorado
United States	Denver Spine (Presbyterian/St. Luke's Hospital)	Greenwood Village	Colorado
United States	Pennsylvania Spine Institute	Harrisburg	Pennsylvania
United States	North Alabama Neurological, P.A.	Huntsville	Alabama
United States	Indiana Spine Group	Indianapolis	Indiana
United States	Lyerly Neurosurgical (Baptist Health)	Jacksonville	Florida
United States	Lyerly Neurosurgical (Centerone)	Jacksonville	Florida
United States	Mayo Clinic	Jacksonville	Florida
United States	East Tennessee Brain and Spine	Johnson City	Tennessee
United States	University of Wisconsin	Madison	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Our Lady of Fatima Hospital	North Providence	Rhode Island
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Heartland Spine	Overland Park	Kansas
United States	Palos Community Hospital	Palos Heights	Illinois
United States	Desert Institute for Spine Care	Phoenix	Arizona
United States	Texas Back Institute	Phoenix	Arizona
United States	West Penn Neurosurgery Group	Pittsburgh	Pennsylvania
United States	Texas Back Institute	Plano	Texas
United States	Capital Neurosurgery	Raleigh	North Carolina
United States	University of Utah	Salt Lake City	Utah
United States	San Antonio Orthopedic Group	San Antonio	Texas
United States	South Texas Spine Clinic	San Antonio	Texas
United States	University of California San Diego	San Diego	California
United States	Central Minnesota Neurosciences	Sartell	Minnesota
United States	Hudson Valley Neurosurgical Associates	Suffern	New York
United States	Atlantic Neurosurgical & Spine	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Anulex Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Re-operations due to re-herniation (repeat discectomy procedure)		2 wks and at 6, 12, 18 and 24 months	No
Secondary	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	No