- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02347410
Spineology Clinical Outcomes Trial: An IDE Investigation (SCOUT)
Spineology Clinical Outcomes Trial: An Investigation Device Exempt (IDE) Performance Goal Clinical Investigation
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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DeLand, Florida, United States, 32720
- Florida Orthopaedic Associates
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Louisiana
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Shreveport, Louisiana, United States, 71101
- Spine Institute of Louisiana
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Thibodaux, Louisiana, United States, 70901
- Thibodaux Regional Medical Center
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Maryland
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Clinton, Maryland, United States, 20735
- Georgetown University Hospital
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham & Women's Hospital
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Peabody, Massachusetts, United States, 01960
- Sports Medicine North
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Michigan
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Kalamazoo, Michigan, United States, 39007
- Bronson Healthcare Methodist Hospital - Neuroscience Center
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Hospital - College of Medicine
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New York
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Buffalo, New York, United States, 14203
- University at Buffalo/SUNY
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Vermont
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South Burlington, Vermont, United States, 05403
- University of Vermont Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Investigation Group
This is a single-arm investigation.
All subjects were treated with the SIFS device filled with bone graft.
Posterior fixation required.
|
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Success
Time Frame: 24 months
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The primary endpoint of this trial is the rate of Patient Success at 24-months defined as a composite endpoint that includes:
For the study to be a success, 68% of subjects need to meet the above success criteria. |
24 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Low Back Pain Score at 24-months Post-operative
Time Frame: 24 months
|
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.
|
24 months
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Mean Back Function Score at 24-months Post-operative
Time Frame: 24 months
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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.
|
24 months
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Mean Right Leg Pain Score at 24-months Post-operative
Time Frame: 24 months
|
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.
|
24 months
|
Mean Left Leg Pain Score at 24-months Post-operative
Time Frame: 24 Months
|
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.
|
24 Months
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Number of Participants With Bridging Bone Presence
Time Frame: 24 months
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Bridging bone demonstrated on CT scan.
Independent Board-certified radiologists determine fusion status.
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24 months
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Number of Participants Experiencing a Device-Related Serious Adverse Event
Time Frame: Intra-Op through 24-month interval
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Events adjudicated by Independent Spine Surgeon Committee that are determined to be a Device-Related Serious Adverse Event (SAE).
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Intra-Op through 24-month interval
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Number of Participants With a Neurological Maintenance or Improvement
Time Frame: 24 months
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Rate of subjects that were neurologically improved or maintained compared to baseline
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24 months
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Number of Participants Working
Time Frame: 24 months
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Compared the number of participants working at 24-months to number of subjects working at baseline
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24 months
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Number of Participants With Narcotic Pain Medication
Time Frame: 24 Months
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Narcotic pain medication use for back pain was compared to baseline.
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24 Months
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Blood Loss
Time Frame: At the conclusion of the surgical procedure, an average of 2.6 hours
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Blood loss (cc) reported for the surgical procedure.
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At the conclusion of the surgical procedure, an average of 2.6 hours
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Duration of Surgery
Time Frame: At the conclusion of the surgical procedure
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Operative time (from incision to closure).
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At the conclusion of the surgical procedure
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Duration of Hospital Stay
Time Frame: From admission through discharge, an average of 2 days
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Number of days subject was in the hospital (from admission to discharge).
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From admission through discharge, an average of 2 days
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Patient Satisfaction
Time Frame: 24-Months
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Subjects rating their procedure as excellent or good
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24-Months
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Donald Erickson, M.D., retired
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 62-180
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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