Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigation Group | Other | This is a single-arm investigation. All subjects were treated with the SIFS device filled with bone graft. Posterior fixation required. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIFS graft containment device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Success | 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Donald Erickson, M.D. | Retired | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Orthopaedic Associates | DeLand | Florida | 32720 | United States | ||
| Spine Institute of Louisiana |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SIFS Graft Containment Device | Investigation Group: Subjects underwent a lumbar interbody fusion using the SIFS Graft Containment Device and supplemental posterior fixation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SIFS Graft Containment Device | Investigational 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
For the study to be a success, 68% of subjects need to meet the above success criteria. | A total of 96 subjects achieved a 24-month exam with complete data (data and CT imaging). | Posted | Count of Participants | Participants | 24 months |
|
From Intraoperative through 24-months postoperative.
All events were adjudicated by independent spine surgeon committee (not investigators).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Investigation Group | This is a single-arm investigation. All subjects were treated with the SIFS device filled with bone graft. Posterior fixation required. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stenosis | Surgical and medical procedures | Stenosis | Systematic Assessment | Secondary intervention due to spinal stenosis |
Not provided
By design, this was a non-randomized trial; all subjects enrolled and treated in this performance goal investigation received the study device.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rose Griffith, Sr. Director, Clinical Affairs | Spineology | 6512568503 | Rgriffith@spineology.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 25, 2014 | Mar 23, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 24 months |
| 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 |
| 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 |
| 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 |
| Number of Participants With Bridging Bone Presence | Bridging bone demonstrated on CT scan. Independent Board-certified radiologists determine fusion status. | 24 months |
| 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 |
| Number of Participants With a Neurological Maintenance or Improvement | Rate of subjects that were neurologically improved or maintained compared to baseline | 24 months |
| Number of Participants Working | Compared the number of participants working at 24-months to number of subjects working at baseline | 24 months |
| Number of Participants With Narcotic Pain Medication | Narcotic pain medication use for back pain was compared to baseline. | 24 Months |
| Blood Loss | Blood loss (cc) reported for the surgical procedure. | At the conclusion of the surgical procedure, an average of 2.6 hours |
| Duration of Surgery | Operative time (from incision to closure). | At the conclusion of the surgical procedure |
| 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 |
| Patient Satisfaction | Subjects rating their procedure as excellent or good | 24-Months |
| Shreveport |
| Louisiana |
| 71101 |
| United States |
| Thibodaux Regional Medical Center | Thibodaux | Louisiana | 70901 | United States |
| Georgetown University Hospital | Clinton | Maryland | 20735 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Sports Medicine North | Peabody | Massachusetts | 01960 | United States |
| Bronson Healthcare Methodist Hospital - Neuroscience Center | Kalamazoo | Michigan | 39007 | United States |
| Mayo Clinic Hospital - College of Medicine | Rochester | Minnesota | 55905 | United States |
| University at Buffalo/SUNY | Buffalo | New York | 14203 | United States |
| University of Vermont Medical Center | South Burlington | Vermont | 05403 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Low Back Pain Status | 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. | Mean | Standard Deviation | units on a scale |
|
| Right Leg Pain Status | 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. | Mean | Standard Deviation | units on a scale |
|
| Left Leg Pain Status | Mean | Standard Deviation | units on a scale |
|
| Back Function Status | 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. | Mean | Standard Deviation | units on a scale |
|
| OG000 | SIFS Investigation Gp | Investigational All subjects treated with the SIFS device, filled with bone graft. Posterior fixation applied. |
|
|
| Other Pre-specified | 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. | The 96 subjects identified represents all subjects that achieved a 24-month study exam. Of the 102 subjects enrolled and treated, 4 subjects exited prior to the 24-month study visit and 2 subjects missed their 24-month evaluation. | Posted | Mean | Standard Deviation | units on a scale | 24 months |
|
|
|
| Other Pre-specified | 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. | The 96 subjects identified represents all subjects that achieved a 24-month study exam. Of the 102 subjects enrolled and treated, 4 subjects exited prior to the 24-month study visit and 2 subjects missed their 24-month evaluation. | Posted | Mean | Standard Deviation | score on a scale | 24 months |
|
|
|
| Other Pre-specified | 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. | The 96 subjects identified represents all subjects that achieved a 24-month study exam. Of the 102 subjects enrolled and treated, 4 subjects exited prior to the 24-month study visit and 2 subjects missed their 24-month evaluation. | Posted | Mean | Standard Deviation | units on a scale | 24 months |
|
|
|
| Other Pre-specified | 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. | The 96 subjects identified represents all subjects that achieved a 24-month study exam. Of the 102 subjects enrolled and treated, 4 subjects exited prior to the 24-month study visit and 2 subjects missed their 24-month evaluation. | Posted | Mean | Standard Deviation | units on a scale | 24 Months |
|
|
|
| Other Pre-specified | Number of Participants With Bridging Bone Presence | Bridging bone demonstrated on CT scan. Independent Board-certified radiologists determine fusion status. | The 96 subjects identified represents all subjects that achieved a 24-month study exam. Of the 102 subjects enrolled and treated, 4 subjects exited prior to the 24-month study visit and 2 subjects missed their 24-month evaluation. | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Other Pre-specified | 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). | The 102 subjects identified represents all subjects enrolled and treated. All subject safety data through 24-months post-operative, regardless of whether a subject exited the study early, is included in the current data point analysis. Note that only 96 of the 102 subjects enrolled and treated achieved a 24-month study exam (4 subjects exited prior to the 24-month study visit and 2 subjects missed their 24-month evaluation). | Posted | Count of Participants | Participants | Intra-Op through 24-month interval |
|
|
|
| Other Pre-specified | Number of Participants With a Neurological Maintenance or Improvement | Rate of subjects that were neurologically improved or maintained compared to baseline | The 96 subjects identified represents all subjects that achieved a 24-month study exam. Of the 102 subjects enrolled and treated, 4 subjects exited prior to the 24-month study visit and 2 subjects missed their 24-month evaluation. | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Other Pre-specified | Number of Participants Working | Compared the number of participants working at 24-months to number of subjects working at baseline | Compared the number of participants working at baseline to the number of participants working at 24-months post-op. | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Other Pre-specified | Number of Participants With Narcotic Pain Medication | Narcotic pain medication use for back pain was compared to baseline. | The 96 subjects identified represents all subjects that achieved a 24-month study exam. Of the 102 subjects enrolled and treated, 4 subjects exited prior to the 24-month study visit and 2 subjects missed their 24-month evaluation. | Posted | Count of Participants | Participants | 24 Months |
|
|
|
| Other Pre-specified | Blood Loss | Blood loss (cc) reported for the surgical procedure. | Posted | Mean | Standard Deviation | cubic centimeters of blood (cc) | At the conclusion of the surgical procedure, an average of 2.6 hours |
|
|
|
| Other Pre-specified | Duration of Surgery | Operative time (from incision to closure). | Posted | Mean | Standard Deviation | hours | At the conclusion of the surgical procedure |
|
|
|
| Other Pre-specified | Duration of Hospital Stay | Number of days subject was in the hospital (from admission to discharge). | Posted | Mean | Standard Deviation | days | From admission through discharge, an average of 2 days |
|
|
|
| Other Pre-specified | Patient Satisfaction | Subjects rating their procedure as excellent or good | Posted | Count of Participants | Participants | 24-Months |
|
|
|
| 1 |
| 102 |
| 12 |
| 102 |
| 0 |
| 102 |
|
| Dural leak | Surgical and medical procedures | Systematic Assessment | Intraop dural leak requiring repair |
|
| Pulmonary thromboembolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Pulmonary thromboembolism requiring hospitalization, subject expired. |
|
| Hematoma | Surgical and medical procedures | Systematic Assessment | Hematoma requiring evacuation. |
|
| Adjacent level disease | Surgical and medical procedures | Systematic Assessment | Adjacent level disease requiring intervention, |
|
| Contralateral leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Contralateral leg pain requiring hospitalization. |
|
| Device improper placement | Surgical and medical procedures | Systematic Assessment | Device improperly placed during index procedure |
|
| Back and leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Ongoing back and leg pain. |
|
Not provided
Not provided