Spineology Clinical Outcomes Trial: An IDE Investigation (SCOUT)

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Study Chair: Donald Erickson, M.D.; Retired

More Information

• Responsible Party: Spineology, Inc
• ClinicalTrials.gov Identifier: NCT02347410
• Other Study ID Numbers: 62-180
• First Posted: January 27, 2015
• Last Update Posted: March 19, 2020
• Last Verified: March 2020

Additional relevant MeSH terms:

Intervertebral Disc Degeneration; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases