Randomized Study of Anular Repair With the Xclose Tissue Repair System
Completed · Phase 4
Conditions studied: Diskectomy
In brief
The purpose of this study is to evaluate the benefits of anulus fibrosus repair utilizing Xclose™ compared to a discectomy without anulus fibrosus repair.
Key facts
- Study ID
- NCT00760799
- Run by
- Anulex Technologies, Inc.
- People needed
- 750
- Starts
- 2007-03-01
- Expected to finish
- 2012-01-01
- Last updated by the study team
- 2012-05-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- North Alabama Neurological, P.A. — Huntsville, Alabama, United States
- Texas Back Institute — Phoenix, Arizona, United States
- Desert Institute for Spine Care — Phoenix, Arizona, United States
- University of California San Diego — San Diego, California, United States
- Denver Spine (Porter Hospital) — Greenwood Village, Colorado, United States
- Denver Spine (Presbyterian/St. Luke's Hospital) — Greenwood Village, Colorado, United States
- North Florida Regional Hospital — Gainesville, Florida, United States
- Lyerly Neurosurgical (Baptist Health) — Jacksonville, Florida, United States
- Mayo Clinic — Jacksonville, Florida, United States
- Lyerly Neurosurgical (Centerone) — Jacksonville, Florida, United States
- Midwest Orthopaedics at Rush — Chicago, Illinois, United States
- Chicago Institute of Neurosurgery and Neuroresearch — Chicago, Illinois, United States
- Palos Community Hospital — Palos Heights, Illinois, United States
- Indiana Spine Group — Indianapolis, Indiana, United States
- Heartland Spine — Overland Park, Kansas, United States
- New England Baptist — Boston, Massachusetts, United States
- Oakwood Hospital — Dearborn, Michigan, United States
- Henry Ford — Detroit, Michigan, United States
- Central Minnesota Neurosciences — Sartell, Minnesota, United States
- University of Nebraska Medical Center — Omaha, Nebraska, United States
- Hudson Valley Neurosurgical Associates — Suffern, New York, United States
- Capital Neurosurgery — Raleigh, North Carolina, United States
- Atlantic Neurosurgical & Spine — Wilmington, North Carolina, United States
- Pennsylvania Spine Institute — Harrisburg, Pennsylvania, United States
- West Penn Neurosurgery Group — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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