Status:
COMPLETED
Randomized Study of Anular Repair With the Xclose Tissue Repair System
Lead Sponsor:
Anulex Technologies, Inc.
Conditions:
Diskectomy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 remo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT00760799
Start Date
March 1 2007
End Date
January 1 2012
Last Update
May 2 2012
Active Locations (34)
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1
North Alabama Neurological, P.A.
Huntsville, Alabama, United States, 35801
2
Texas Back Institute
Phoenix, Arizona, United States, 85015
3
Desert Institute for Spine Care
Phoenix, Arizona, United States, 85020
4
University of California San Diego
San Diego, California, United States, 92103