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Spineology Clinical Outcomes Trial: An IDE Investigation (SCOUT)

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ClinicalTrials.gov Identifier: NCT02347410
Recruitment Status : Completed
First Posted : January 27, 2015
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Spineology, Inc

Brief Summary:
This study evaluates the safety and effectiveness of the Spineology Interbody Fusion System (SIFS) in an instrumented interbody lumbar fusion in subjects presenting with symptomatic single-level lumbar degenerative disc disease.

Condition or disease Intervention/treatment Phase
Lumbar Degenerative Disc Disease Device: SIFS graft containment device Not Applicable

Detailed Description:

This regulated prospective, multi-center, Institutional Review Board (IRB) approved single-arm performance goal clinical investigation will be conducted at a maximum of 15 centers with no more than 102 subjects being enrolled and treated.

It is anticipated that enrollment will be compete within 24 months. Subjects will be actively evaluated to 24-months postoperative and depending on enrollment duration, may be remotely assessed through self-administered surveys at 36- and 48-months.

The primary endpoint, assessed at 24-months postoperative, is a composite score that includes pain, function, fusion and safety assessments.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Spineology Clinical Outcomes Trial: An Investigation Device Exempt (IDE) Performance Goal Clinical Investigation
Actual Study Start Date : January 22, 2015
Actual Primary Completion Date : January 22, 2020
Actual Study Completion Date : March 4, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
SIFS Graft Containment Device
Investigational
Device: 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 Name: SIFS mesh




Primary Outcome Measures :
  1. Patient Success (Composite score that evaluates improvement in low back pain and low back function in addition to presence of bridging bone and no device-related serious adverse events through the 24 month time point) [ Time Frame: 24-months post-operative ]
    Composite score that evaluates improvement in low back pain and low back function in addition to presence of bridging bone and no device-related serious adverse events through the 24 month time point.


Other Outcome Measures:
  1. Low back pain (100mm Visual Analog Score (VAS) [ Time Frame: 12- and 24-months ]
    Low back pain will be measured on a 100mm Visual Analog Score (VAS) and compared to baseline

  2. Lower limb pain (100mm Visual Analog Score (VAS) [ Time Frame: 12- and 24-months ]
    Bilateral lower limb pain will be measured on a 100mm VAS and compared to baseline

  3. Low back function (Oswestry Disability Index (ODI) score) [ Time Frame: 12 and 24-month interval ]
    Oswestry Disability Index (ODI) score will be compared to baseline

  4. Fusion assessment (Assessment of bridging bone presence on CT scan) [ Time Frame: 12 and 24-month interval ]
    Assessment of bridging bone presence on CT scan

  5. Adverse Event (AE) assessment [ Time Frame: 12 and 24-month interval ]
    Evaluation of all events reported in this investigation

  6. Analysis of neurological status [ Time Frame: 12 and 24-month interval ]
    All elements of neurological status (strength, sensation, and reflexes) will be assessed for maintenance or improvement from baseline

  7. Radiographic data assessments (evaluated for the following findings: device expulsion, migration, subsidence and significant radiolucency) [ Time Frame: 12 and 24-month interval ]
    Study radiographs will be evaluated for the following findings: device expulsion, migration, subsidence and significant radiolucency

  8. Analysis of work status [ Time Frame: 12 and 24-month interval ]
    Work status (working, not working, retired, etc.) will be compared to baseline

  9. Pain medication use [ Time Frame: 12 and 24-month interval ]
    Pain medication use will be compared to baseline

  10. Hospital variable 1 - Estimated Blood Loss [ Time Frame: At the conclusion of the surgical procedure ]
    The estimated estimated blood loss (cc) will be reported

  11. Hospital variable 2 - Duration of surgery [ Time Frame: At the conclusion of the surgical procedure ]
    Operative time (mins) will be reported

  12. Hospital variable 3 - Duration of Stay [ Time Frame: Participants will be followed for the duration of the hospital stay, an expected average of 3 days. ]
    The lengthy of the hospitial stay (days) will be reported



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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Skeletally mature;
  • Confirmed symptomatic single-level lumbar degenerative disc disease (DDD) between L2 and S1;
  • Minimum low back VAS pain score of 40mm;
  • Minimum 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:

  • Previous fusion or total disc replacement at the index level;
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02347410


Locations
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United States, Florida
Florida Orthopaedic Associates
DeLand, Florida, United States, 32720
United States, Louisiana
Spine Institute of Louisiana
Shreveport, Louisiana, United States, 71101
Thibodaux Regional Medical Center
Thibodaux, Louisiana, United States, 70901
United States, Maryland
Georgetown University Hospital
Clinton, Maryland, United States, 20735
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Sports Medicine North
Peabody, Massachusetts, United States, 01960
United States, Michigan
Bronson Healthcare Methodist Hospital - Neuroscience Center
Kalamazoo, Michigan, United States, 39007
United States, Minnesota
Mayo Clinic Hospital - College of Medicine
Rochester, Minnesota, United States, 55905
United States, New York
University at Buffalo/SUNY
Buffalo, New York, United States, 14203
United States, Vermont
University of Vermont Medical Center
South Burlington, Vermont, United States, 05403
Sponsors and Collaborators
Spineology, Inc
Investigators
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Study Chair: Donald Erickson, M.D. Retired
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Responsible Party: Spineology, Inc
ClinicalTrials.gov Identifier: NCT02347410    
Other Study ID Numbers: 62-180
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases