Spineology Clinical Outcomes Trial: An IDE Investigation
NCT ID: NCT02347410
Last Updated: 2021-10-20
Study Results
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View full resultsBasic Information
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COMPLETED
NA
102 participants
INTERVENTIONAL
2015-01-22
2020-03-04
Brief Summary
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Detailed Description
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Subjects were actively evaluated from pre-op to 24-months postoperative. Based on enrollment duration, some subjects were remotely assessed through self-administered surveys at 36- and/or 48-months.
The primary endpoint, assessed at 24-months postoperative, is a composite score that includes pain, function, fusion and safety assessments.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Investigation Group
This is a single-arm investigation. All subjects were treated with the SIFS device filled with bone graft. Posterior fixation required.
SIFS graft containment device
The SIFS mesh is a graft containment and reinforcement device. Following conventional thorough discectomy, the disc space is entered through a small portal in the annulus, the SIFS mesh is introduced, deployed and then filled with bone graft. Bilateral commercially available posterior lumbar fixation is applied.
Interventions
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SIFS graft containment device
The SIFS mesh is a graft containment and reinforcement device. Following conventional thorough discectomy, the disc space is entered through a small portal in the annulus, the SIFS mesh is introduced, deployed and then filled with bone graft. Bilateral commercially available posterior lumbar fixation is applied.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed symptomatic single-level lumbar degenerative disc disease (DDD) between L2 and S1;
* Minimum low back Visual Analog Scale (VAS) pain score of 40mm;
* Minimum Oswestry Disability Index (ODI) score of 40;
* Received at least 6-months of conservative care; and
* Willing and able to comply with protocol evaluations and provide informed consent.
Exclusion Criteria
* Greater than Grade I spondylolisthesis;
* Has symptomatic multi-level lumbar DDD;
* Active systemic infection or infection at the local surgical site;
* Active or suspected malignancy;
* Body Mass Index of greater than or equal to 40;
* Significant metabolic bone disease;
* Taking medication known to interfere with bone healing;
* Has a current substance abuse disorder;
* Has a somatoform, dissociative, eating or psychotic disorder;
* Waddell Signs of inorganic behavior;
* Current tobacco user;
* Is a prisoner;
* If female, pregnant or contemplating pregnancy during follow-up period; or
* Enrolled in a concurrent clinical investigation that may confound the findings of the current investigation
21 Years
80 Years
ALL
No
Sponsors
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Spineology, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Donald Erickson, M.D.
Role: STUDY_CHAIR
Retired
Locations
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Florida Orthopaedic Associates
DeLand, Florida, United States
Spine Institute of Louisiana
Shreveport, Louisiana, United States
Thibodaux Regional Medical Center
Thibodaux, Louisiana, United States
Georgetown University Hospital
Clinton, Maryland, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Sports Medicine North
Peabody, Massachusetts, United States
Bronson Healthcare Methodist Hospital - Neuroscience Center
Kalamazoo, Michigan, United States
Mayo Clinic Hospital - College of Medicine
Rochester, Minnesota, United States
University at Buffalo/SUNY
Buffalo, New York, United States
University of Vermont Medical Center
South Burlington, Vermont, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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62-180
Identifier Type: -
Identifier Source: org_study_id