Lumbar Degenerative Disc Disease Clinical Trial
— SCOUTOfficial title:
Spineology Clinical Outcomes Trial: An Investigation Device Exempt (IDE) Performance Goal Clinical Investigation
NCT number | NCT02347410 |
Other study ID # | 62-180 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 22, 2015 |
Est. completion date | March 4, 2020 |
Verified date | October 2021 |
Source | Spineology, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 102 |
Est. completion date | March 4, 2020 |
Est. primary completion date | January 22, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Brigham & Women's Hospital | Boston | Massachusetts |
United States | University at Buffalo/SUNY | Buffalo | New York |
United States | Georgetown University Hospital | Clinton | Maryland |
United States | Florida Orthopaedic Associates | DeLand | Florida |
United States | Bronson Healthcare Methodist Hospital - Neuroscience Center | Kalamazoo | Michigan |
United States | Sports Medicine North | Peabody | Massachusetts |
United States | Mayo Clinic Hospital - College of Medicine | Rochester | Minnesota |
United States | Spine Institute of Louisiana | Shreveport | Louisiana |
United States | University of Vermont Medical Center | South Burlington | Vermont |
United States | Thibodaux Regional Medical Center | Thibodaux | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Spineology, Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Mean Low Back Pain Score at 24-months Post-operative | 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 | |
Other | Mean Back Function Score at 24-months Post-operative | 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 | |
Other | Mean Right Leg Pain Score at 24-months Post-operative | 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 | |
Other | Mean Left Leg Pain Score at 24-months Post-operative | 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 | |
Other | Number of Participants With Bridging Bone Presence | Bridging bone demonstrated on CT scan. Independent Board-certified radiologists determine fusion status. | 24 months | |
Other | Number of Participants Experiencing a Device-Related Serious Adverse Event | Events adjudicated by Independent Spine Surgeon Committee that are determined to be a Device-Related Serious Adverse Event (SAE). | Intra-Op through 24-month interval | |
Other | Number of Participants With a Neurological Maintenance or Improvement | Rate of subjects that were neurologically improved or maintained compared to baseline | 24 months | |
Other | Number of Participants Working | Compared the number of participants working at 24-months to number of subjects working at baseline | 24 months | |
Other | Number of Participants With Narcotic Pain Medication | Narcotic pain medication use for back pain was compared to baseline. | 24 Months | |
Other | Blood Loss | Blood loss (cc) reported for the surgical procedure. | At the conclusion of the surgical procedure, an average of 2.6 hours | |
Other | Duration of Surgery | Operative time (from incision to closure). | At the conclusion of the surgical procedure | |
Other | Duration of Hospital Stay | Number of days subject was in the hospital (from admission to discharge). | From admission through discharge, an average of 2 days | |
Other | Patient Satisfaction | Subjects rating their procedure as excellent or good | 24-Months | |
Primary | 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. |
24 months |
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