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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date October 2021
Source Spineology, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Spineology, Inc

Country where clinical trial is conducted

United States, 

Outcome

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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