Randomized Study of Anular Repair With the Xclose Tissue Repair System
- Conditions
- Diskectomy
- Interventions
- Procedure: Discectomy with anular repair
- Registration Number
- NCT00760799
- Lead Sponsor
- Anulex Technologies, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 750
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Discectomy with anular repair Standard discectomy without anular repair 2 Discectomy with anular repair Standard Discectomy with anular repair
- Primary Outcome Measures
Name Time Method Re-operations due to re-herniation (repeat discectomy procedure) 2 wks and at 6, 12, 18 and 24 months
- Secondary Outcome Measures
Name Time Method 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
Related Research Topics
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Trial Locations
- Locations (33)
Heartland Spine
🇺🇸Overland Park, Kansas, United States
Wyoming Spine and Neurosurgery Associates
🇺🇸Cheyenne, Wyoming, United States
Texas Back Institute
🇺🇸Plano, Texas, United States
Chicago Institute of Neurosurgery and Neuroresearch
🇺🇸Chicago, Illinois, United States
Palos Community Hospital
🇺🇸Palos Heights, Illinois, United States
Oakwood Hospital
🇺🇸Dearborn, Michigan, United States
New England Baptist
🇺🇸Boston, Massachusetts, United States
Henry Ford
🇺🇸Detroit, Michigan, United States
West Penn Neurosurgery Group
🇺🇸Pittsburgh, Pennsylvania, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Desert Institute for Spine Care
🇺🇸Phoenix, Arizona, United States
North Alabama Neurological, P.A.
🇺🇸Huntsville, Alabama, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
University of California San Diego
🇺🇸San Diego, California, United States
Lyerly Neurosurgical (Centerone)
🇺🇸Jacksonville, Florida, United States
Midwest Orthopaedics at Rush
🇺🇸Chicago, Illinois, United States
Central Minnesota Neurosciences
🇺🇸Sartell, Minnesota, United States
Capital Neurosurgery
🇺🇸Raleigh, North Carolina, United States
San Antonio Orthopedic Group
🇺🇸San Antonio, Texas, United States
Atlantic Neurosurgical & Spine
🇺🇸Wilmington, North Carolina, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
North Florida Regional Hospital
🇺🇸Gainesville, Florida, United States
East Tennessee Brain and Spine
🇺🇸Johnson City, Tennessee, United States
South Texas Spine Clinic
🇺🇸San Antonio, Texas, United States
Denver Spine (Presbyterian/St. Luke's Hospital)
🇺🇸Greenwood Village, Colorado, United States
Lyerly Neurosurgical (Baptist Health)
🇺🇸Jacksonville, Florida, United States
Hudson Valley Neurosurgical Associates
🇺🇸Suffern, New York, United States
Denver Spine (Porter Hospital)
🇺🇸Greenwood Village, Colorado, United States
Indiana Spine Group
🇺🇸Indianapolis, Indiana, United States
Our Lady of Fatima Hospital
🇺🇸North Providence, Rhode Island, United States
Pennsylvania Spine Institute
🇺🇸Harrisburg, Pennsylvania, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States