Clinical trial NCT00760799: Randomized Study of Anular Repair With the Xclose Tissue Repair System
Official title: Randomized Study of Anular Repair With the Xclose Tissue Repair System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diskectomy
Keywords: Lumbar Disc Herniation
Lead sponsor: Anulex Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2008-09-26
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Re-operations due to re-herniation (repeat discectomy procedure)
timeFrame: 2 wks and at 6, 12, 18 and 24 months
Secondary outcomes:
measure: Patient outcomes (utilizing Oswestry Disability Index, Visual Analog Scale and SF-12 quality of life assessment), Health care utilization, Return to work
timeFrame: 2 weeks and at 6, 12, 18, and 24 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: North Alabama Neurological, P.A.
state: Alabama
city: Phoenix
country: United States
facility: Texas Back Institute
state: Arizona
city: Phoenix
country: United States
facility: Desert Institute for Spine Care
state: Arizona
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Greenwood Village
country: United States
facility: Denver Spine (Porter Hospital)
state: Colorado
city: Greenwood Village
country: United States
facility: Denver Spine (Presbyterian/St. Luke's Hospital)
state: Colorado
city: Gainesville
country: United States
facility: North Florida Regional Hospital
state: Florida
city: Jacksonville
country: United States
facility: Lyerly Neurosurgical (Baptist Health)
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Jacksonville
country: United States
facility: Lyerly Neurosurgical (Centerone)
state: Florida
city: Chicago
country: United States
facility: Midwest Orthopaedics at Rush
state: Illinois
city: Chicago
country: United States
facility: Chicago Institute of Neurosurgery and Neuroresearch
state: Illinois
city: Palos Heights
country: United States
facility: Palos Community Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Spine Group
state: Indiana
city: Overland Park
country: United States
facility: Heartland Spine
state: Kansas
city: Boston
country: United States
facility: New England Baptist
state: Massachusetts
city: Dearborn
country: United States
facility: Oakwood Hospital
state: Michigan
city: Detroit
country: United States
facility: Henry Ford
state: Michigan
city: Sartell
country: United States
facility: Central Minnesota Neurosciences
state: Minnesota
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Suffern
country: United States
facility: Hudson Valley Neurosurgical Associates
state: New York
city: Raleigh
country: United States
facility: Capital Neurosurgery
state: North Carolina
city: Wilmington
country: United States
facility: Atlantic Neurosurgical & Spine
state: North Carolina
city: Harrisburg
country: United States
facility: Pennsylvania Spine Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: West Penn Neurosurgery Group
state: Pennsylvania
city: North Providence
country: United States
facility: Our Lady of Fatima Hospital
state: Rhode Island
city: Johnson City
country: United States
facility: East Tennessee Brain and Spine
state: Tennessee
city: Plano
country: United States
facility: Texas Back Institute
state: Texas
city: San Antonio
country: United States
facility: San Antonio Orthopedic Group
state: Texas
city: San Antonio
country: United States
facility: South Texas Spine Clinic
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Cheyenne
country: United States
facility: Wyoming Spine and Neurosurgery Associates
state: Wyoming
Study officials:
References:
citation: 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.