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Spineology Clinical Outcomes Trial: An IDE Investigation (SCOUT)

Primary Purpose

Lumbar Degenerative Disc Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SIFS graft containment device
Sponsored by
Spineology, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Degenerative Disc Disease

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Skeletally mature;
  • 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:

  • 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

Sites / Locations

  • Florida Orthopaedic Associates
  • Spine Institute of Louisiana
  • Thibodaux Regional Medical Center
  • Georgetown University Hospital
  • Brigham & Women's Hospital
  • Sports Medicine North
  • Bronson Healthcare Methodist Hospital - Neuroscience Center
  • Mayo Clinic Hospital - College of Medicine
  • University at Buffalo/SUNY
  • University of Vermont Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Investigation Group

Arm Description

This is a single-arm investigation. All subjects were treated with the SIFS device filled with bone graft. Posterior fixation required.

Outcomes

Primary Outcome Measures

Overall Success
The primary endpoint of this trial is the rate of Patient Success at 24-months defined as a composite endpoint that includes: Pain -- Clinically meaningful reduction in low back pain Visual Analog Scale (VAS) score at 24-months post-operative. A clinically meaningful reduction is defined as a difference of at least 20 mm compared to pre-op (pre-op score minus post-op score). Function -- Clinically meaningful improvement in function at 24-months post-operative. A clinically meaningful improvement is defined as a reduction of at least 15 points compared to baseline (pre-op Oswestry Disability Index (ODI) score minus the post-op ODI score). Fusion -- Defined as bridging bone demonstrated on computed tomography (CT) scan Safety -- No device-related serious adverse events (SAEs) from intra-op through the 24-month timepoint. For the study to be a success, 68% of subjects need to meet the above success criteria.

Secondary Outcome Measures

Full Information

First Posted
January 13, 2015
Last Updated
October 6, 2021
Sponsor
Spineology, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02347410
Brief Title
Spineology Clinical Outcomes Trial: An IDE Investigation
Acronym
SCOUT
Official Title
Spineology Clinical Outcomes Trial: An Investigation Device Exempt (IDE) Performance Goal Clinical Investigation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 22, 2015 (Actual)
Primary Completion Date
January 22, 2020 (Actual)
Study Completion Date
March 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spineology, Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluated 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.
Detailed Description
This regulated prospective, multi-center, Institutional Review Board (IRB) approved single-arm performance goal clinical investigation was conducted at 10 centers with 102 subjects being enrolled and treated. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Degenerative Disc Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Investigation Group
Arm Type
Other
Arm Description
This is a single-arm investigation. All subjects were treated with the SIFS device filled with bone graft. Posterior fixation required.
Intervention Type
Device
Intervention Name(s)
SIFS graft containment device
Other Intervention Name(s)
SIFS mesh
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Success
Description
The primary endpoint of this trial is the rate of Patient Success at 24-months defined as a composite endpoint that includes: Pain -- Clinically meaningful reduction in low back pain Visual Analog Scale (VAS) score at 24-months post-operative. A clinically meaningful reduction is defined as a difference of at least 20 mm compared to pre-op (pre-op score minus post-op score). Function -- Clinically meaningful improvement in function at 24-months post-operative. A clinically meaningful improvement is defined as a reduction of at least 15 points compared to baseline (pre-op Oswestry Disability Index (ODI) score minus the post-op ODI score). Fusion -- Defined as bridging bone demonstrated on computed tomography (CT) scan Safety -- No device-related serious adverse events (SAEs) from intra-op through the 24-month timepoint. For the study to be a success, 68% of subjects need to meet the above success criteria.
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Mean Low Back Pain Score at 24-months Post-operative
Description
A Visual Analog Scale (VAS) score was used to evaluate a subject's level of pain. The VAS is a 100 mm horizontal line where score of "0" represents "No Pain" and a score of "100" represents the "Worst possible" pain. The subject marks a vertical line across the horizontal line representing their pain level. The pain score is obtained by using a ruler to measure where the vertical line intersects the horizontal line. Improvement is defined as a clinically meaningful difference (20 mm reduction) when compared to pre-op. Success for this parameter is evaluated at the 24-month visit.
Time Frame
24 months
Title
Mean Back Function Score at 24-months Post-operative
Description
A subject's back function was assessed by the Oswestry Disability Index (ODI). The ODI is a 10 question survey that evaluates the degree of functional impairment. Completion of the survey yields a score from "0" to "100" points. A score of "0" represents "No disability" and "100" represents "Total disability". A clinically meaningful difference is defined as a 15-point reduction when compared to pre-op. Success for this parameter is evaluated at the 24-month visit.
Time Frame
24 months
Title
Mean Right Leg Pain Score at 24-months Post-operative
Description
A Visual Analog Scale (VAS) score was used to evaluate a subject's level of pain. The VAS is a 100 mm horizontal line where score of "0" represents "No Pain" and a score of "100" represents the "Worst possible" pain. The subject marks a vertical line across the horizontal line representing their pain level. The pain score is obtained by using a ruler to measure where the vertical line intersects the horizontal line. Improvement is defined as a clinically meaningful difference (20 mm reduction) when compared to pre-op. Success for this parameter is evaluated at the 24-month visit.
Time Frame
24 months
Title
Mean Left Leg Pain Score at 24-months Post-operative
Description
A Visual Analog Scale (VAS) score was used to evaluate a subject's level of pain. The VAS is a 100 mm horizontal line where score of "0" represents "No Pain" and a score of "100" represents the "Worst possible" pain. The subject marks a vertical line across the horizontal line representing their pain level. The pain score is obtained by using a ruler to measure where the vertical line intersects the horizontal line. Improvement is defined as a clinically meaningful difference (20 mm reduction) when compared to pre-op. Success for this parameter is evaluated at the 24-month visit.
Time Frame
24 Months
Title
Number of Participants With Bridging Bone Presence
Description
Bridging bone demonstrated on CT scan. Independent Board-certified radiologists determine fusion status.
Time Frame
24 months
Title
Number of Participants Experiencing a Device-Related Serious Adverse Event
Description
Events adjudicated by Independent Spine Surgeon Committee that are determined to be a Device-Related Serious Adverse Event (SAE).
Time Frame
Intra-Op through 24-month interval
Title
Number of Participants With a Neurological Maintenance or Improvement
Description
Rate of subjects that were neurologically improved or maintained compared to baseline
Time Frame
24 months
Title
Number of Participants Working
Description
Compared the number of participants working at 24-months to number of subjects working at baseline
Time Frame
24 months
Title
Number of Participants With Narcotic Pain Medication
Description
Narcotic pain medication use for back pain was compared to baseline.
Time Frame
24 Months
Title
Blood Loss
Description
Blood loss (cc) reported for the surgical procedure.
Time Frame
At the conclusion of the surgical procedure, an average of 2.6 hours
Title
Duration of Surgery
Description
Operative time (from incision to closure).
Time Frame
At the conclusion of the surgical procedure
Title
Duration of Hospital Stay
Description
Number of days subject was in the hospital (from admission to discharge).
Time Frame
From admission through discharge, an average of 2 days
Title
Patient Satisfaction
Description
Subjects rating their procedure as excellent or good
Time Frame
24-Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Skeletally mature; 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Erickson, M.D.
Organizational Affiliation
Retired
Official's Role
Study Chair
Facility Information:
Facility Name
Florida Orthopaedic Associates
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Spine Institute of Louisiana
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Thibodaux Regional Medical Center
City
Thibodaux
State/Province
Louisiana
ZIP/Postal Code
70901
Country
United States
Facility Name
Georgetown University Hospital
City
Clinton
State/Province
Maryland
ZIP/Postal Code
20735
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Sports Medicine North
City
Peabody
State/Province
Massachusetts
ZIP/Postal Code
01960
Country
United States
Facility Name
Bronson Healthcare Methodist Hospital - Neuroscience Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
39007
Country
United States
Facility Name
Mayo Clinic Hospital - College of Medicine
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University at Buffalo/SUNY
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
University of Vermont Medical Center
City
South Burlington
State/Province
Vermont
ZIP/Postal Code
05403
Country
United States

12. IPD Sharing Statement

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Spineology Clinical Outcomes Trial: An IDE Investigation

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