Diskectomy Clinical Trial
Official title:
Randomized Study of Anular Repair With the Xclose Tissue Repair System
Verified date | May 2012 |
Source | Anulex Technologies, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this study is to evaluate the benefits of anulus fibrosus repair utilizing Xclose™ compared to a discectomy without anulus fibrosus repair.
Status | Completed |
Enrollment | 750 |
Est. completion date | January 2012 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | New England Baptist | Boston | Massachusetts |
United States | Wyoming Spine and Neurosurgery Associates | Cheyenne | Wyoming |
United States | Chicago Institute of Neurosurgery and Neuroresearch | Chicago | Illinois |
United States | Midwest Orthopaedics at Rush | Chicago | Illinois |
United States | Oakwood Hospital | Dearborn | Michigan |
United States | Henry Ford | Detroit | Michigan |
United States | North Florida Regional Hospital | Gainesville | Florida |
United States | Denver Spine (Porter Hospital) | Greenwood Village | Colorado |
United States | Denver Spine (Presbyterian/St. Luke's Hospital) | Greenwood Village | Colorado |
United States | Pennsylvania Spine Institute | Harrisburg | Pennsylvania |
United States | North Alabama Neurological, P.A. | Huntsville | Alabama |
United States | Indiana Spine Group | Indianapolis | Indiana |
United States | Lyerly Neurosurgical (Baptist Health) | Jacksonville | Florida |
United States | Lyerly Neurosurgical (Centerone) | Jacksonville | Florida |
United States | Mayo Clinic | Jacksonville | Florida |
United States | East Tennessee Brain and Spine | Johnson City | Tennessee |
United States | University of Wisconsin | Madison | Wisconsin |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Our Lady of Fatima Hospital | North Providence | Rhode Island |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Heartland Spine | Overland Park | Kansas |
United States | Palos Community Hospital | Palos Heights | Illinois |
United States | Desert Institute for Spine Care | Phoenix | Arizona |
United States | Texas Back Institute | Phoenix | Arizona |
United States | West Penn Neurosurgery Group | Pittsburgh | Pennsylvania |
United States | Texas Back Institute | Plano | Texas |
United States | Capital Neurosurgery | Raleigh | North Carolina |
United States | University of Utah | Salt Lake City | Utah |
United States | San Antonio Orthopedic Group | San Antonio | Texas |
United States | South Texas Spine Clinic | San Antonio | Texas |
United States | University of California San Diego | San Diego | California |
United States | Central Minnesota Neurosciences | Sartell | Minnesota |
United States | Hudson Valley Neurosurgical Associates | Suffern | New York |
United States | Atlantic Neurosurgical & Spine | Wilmington | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Anulex Technologies, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Re-operations due to re-herniation (repeat discectomy procedure) | 2 wks and at 6, 12, 18 and 24 months | No | |
Secondary | 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 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
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