Randomized Study of Anular Repair With the Xclose Tissue Repair System
1 other identifier
interventional
750
1 country
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2007
Longer than P75 for phase_4
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 25, 2008
CompletedFirst Posted
Study publicly available on registry
September 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedMay 2, 2012
May 1, 2012
4.8 years
September 25, 2008
May 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Re-operations due to re-herniation (repeat discectomy procedure)
2 wks and at 6, 12, 18 and 24 months
Secondary Outcomes (1)
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
Study Arms (2)
1
ACTIVE COMPARATORStandard discectomy without anular repair
2
EXPERIMENTALStandard Discectomy with anular repair
Interventions
Comparison of discectomy with and without repair to the anulus fibrosus of the intervertebral disc
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
North Alabama Neurological, P.A.
Huntsville, Alabama, 35801, United States
Texas Back Institute
Phoenix, Arizona, 85015, United States
Desert Institute for Spine Care
Phoenix, Arizona, 85020, United States
University of California San Diego
San Diego, California, 92103, United States
Denver Spine (Porter Hospital)
Greenwood Village, Colorado, 80111, United States
Denver Spine (Presbyterian/St. Luke's Hospital)
Greenwood Village, Colorado, 80111, United States
North Florida Regional Hospital
Gainesville, Florida, 32605, United States
Lyerly Neurosurgical (Baptist Health)
Jacksonville, Florida, 32207, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Lyerly Neurosurgical (Centerone)
Jacksonville, Florida, 32256, United States
Midwest Orthopaedics at Rush
Chicago, Illinois, 60612, United States
Chicago Institute of Neurosurgery and Neuroresearch
Chicago, Illinois, 60640, United States
Palos Community Hospital
Palos Heights, Illinois, 60463, United States
Indiana Spine Group
Indianapolis, Indiana, 46260, United States
Heartland Spine
Overland Park, Kansas, 66211, United States
New England Baptist
Boston, Massachusetts, 02120, United States
Oakwood Hospital
Dearborn, Michigan, 48124, United States
Henry Ford
Detroit, Michigan, 48202, United States
Central Minnesota Neurosciences
Sartell, Minnesota, 56377, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-2035, United States
Hudson Valley Neurosurgical Associates
Suffern, New York, 10901, United States
Capital Neurosurgery
Raleigh, North Carolina, 27609, United States
Atlantic Neurosurgical & Spine
Wilmington, North Carolina, 28401-7593, United States
Pennsylvania Spine Institute
Harrisburg, Pennsylvania, 17109, United States
West Penn Neurosurgery Group
Pittsburgh, Pennsylvania, 15232, United States
Our Lady of Fatima Hospital
North Providence, Rhode Island, 02904, United States
East Tennessee Brain and Spine
Johnson City, Tennessee, 37604, United States
Texas Back Institute
Plano, Texas, 75093, United States
San Antonio Orthopedic Group
San Antonio, Texas, 75216, United States
South Texas Spine Clinic
San Antonio, Texas, 75258, United States
University of Utah
Salt Lake City, Utah, 84112, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Wyoming Spine and Neurosurgery Associates
Cheyenne, Wyoming, 82009, United States
Related Publications (1)
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.
PMID: 23392414DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2008
First Posted
September 26, 2008
Study Start
March 1, 2007
Primary Completion
December 1, 2011
Study Completion
January 1, 2012
Last Updated
May 2, 2012
Record last verified: 2012-05