SCOUT: Spineology Clinical Outcomes Trial: An IDE Investigation
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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. |
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Success [24 months]
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.
Other Outcome Measures
- Mean Low Back Pain Score at 24-months Post-operative [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.
- Mean Back Function Score at 24-months Post-operative [24 months]
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 Right Leg Pain Score at 24-months Post-operative [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.
- Mean Left Leg Pain Score at 24-months Post-operative [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.
- Number of Participants With Bridging Bone Presence [24 months]
Bridging bone demonstrated on CT scan. Independent Board-certified radiologists determine fusion status.
- Number of Participants Experiencing a Device-Related Serious Adverse Event [Intra-Op through 24-month interval]
Events adjudicated by Independent Spine Surgeon Committee that are determined to be a Device-Related Serious Adverse Event (SAE).
- Number of Participants With a Neurological Maintenance or Improvement [24 months]
Rate of subjects that were neurologically improved or maintained compared to baseline
- Number of Participants Working [24 months]
Compared the number of participants working at 24-months to number of subjects working at baseline
- Number of Participants With Narcotic Pain Medication [24 Months]
Narcotic pain medication use for back pain was compared to baseline.
- Blood Loss [At the conclusion of the surgical procedure, an average of 2.6 hours]
Blood loss (cc) reported for the surgical procedure.
- Duration of Surgery [At the conclusion of the surgical procedure]
Operative time (from incision to closure).
- Duration of Hospital Stay [From admission through discharge, an average of 2 days]
Number of days subject was in the hospital (from admission to discharge).
- Patient Satisfaction [24-Months]
Subjects rating their procedure as excellent or good
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Florida Orthopaedic Associates | DeLand | Florida | United States | 32720 |
| 2 | Spine Institute of Louisiana | Shreveport | Louisiana | United States | 71101 |
| 3 | Thibodaux Regional Medical Center | Thibodaux | Louisiana | United States | 70901 |
| 4 | Georgetown University Hospital | Clinton | Maryland | United States | 20735 |
| 5 | Brigham & Women's Hospital | Boston | Massachusetts | United States | 02115 |
| 6 | Sports Medicine North | Peabody | Massachusetts | United States | 01960 |
| 7 | Bronson Healthcare Methodist Hospital - Neuroscience Center | Kalamazoo | Michigan | United States | 39007 |
| 8 | Mayo Clinic Hospital - College of Medicine | Rochester | Minnesota | United States | 55905 |
| 9 | University at Buffalo/SUNY | Buffalo | New York | United States | 14203 |
| 10 | University of Vermont Medical Center | South Burlington | Vermont | United States | 05403 |
Sponsors and Collaborators
- Spineology, Inc
Investigators
- Study Chair: Donald Erickson, M.D., Retired
Study Documents (Full-Text)
More Information
Publications
None provided.- 62-180
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | SIFS Graft Containment Device |
|---|---|
| Arm/Group Description | Investigation Group: Subjects underwent a lumbar interbody fusion using the SIFS Graft Containment Device and supplemental posterior fixation. |
| Period Title: Overall Study | |
| STARTED | 102 |
| COMPLETED | 98 |
| NOT COMPLETED | 4 |
Baseline Characteristics
| Arm/Group Title | SIFS Graft Containment Device |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 102 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
71
69.6%
|
| >=65 years |
31
30.4%
|
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
57.0
(12.0)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
51
50%
|
| Male |
51
50%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
4
3.9%
|
| Not Hispanic or Latino |
98
96.1%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
4
3.9%
|
| White |
96
94.1%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
2
2%
|
| Region of Enrollment (participants) [Number] | |
| United States |
102
100%
|
| Low Back Pain Status (units on a scale) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [units on a scale] |
74.1
(16.1)
|
| Right Leg Pain Status (units on a scale) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [units on a scale] |
42.9
(34.1)
|
| Left Leg Pain Status (units on a scale) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [units on a scale] |
52.9
(32.4)
|
| Back Function Status (units on a scale) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [units on a scale] |
53.60
(11.7)
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A total of 96 subjects achieved a 24-month exam with complete data (data and CT imaging). |
| Arm/Group Title | SIFS Investigation Gp |
|---|---|
| Arm/Group Description | Investigational All subjects treated with the SIFS device, filled with bone graft. Posterior fixation applied. |
| Measure Participants | 96 |
| Count of Participants [Participants] |
71
69.6%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Investigation Group |
|---|---|
| Arm/Group Description | Investigational All subjects (102) were treated with the SIFS device, filled with bone graft. Bilateral posterior fixation was applied. |
| Measure Participants | 96 |
| Mean (Standard Deviation) [units on a scale] |
21.8
(24.5)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Investigation Group |
|---|---|
| Arm/Group Description | This is a single-arm investigation. All subjects were treated with the SIFS device filled with bone graft. Posterior fixation required. |
| Measure Participants | 96 |
| Mean (Standard Deviation) [score on a scale] |
21.0
(19.3)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | SIFS Graft Containment Device |
|---|---|
| Arm/Group Description | Subjects underwent Interbody Fusion using the Graft Containment Device with supplemental fixation. |
| Measure Participants | 96 |
| Mean (Standard Deviation) [units on a scale] |
10.5
(19.5)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | SIFS Graft Containment Device |
|---|---|
| Arm/Group Description | Subjects underwent Interbody Fusion using the Graft Containment Device with supplemental fixation. |
| Measure Participants | 96 |
| Mean (Standard Deviation) [units on a scale] |
13.2
(22.6)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | SIFS Graft Containment Device |
|---|---|
| Arm/Group Description | Subjects underwent Interbody Fusion using the Graft Containment Device with supplemental fixation. |
| Measure Participants | 96 |
| Count of Participants [Participants] |
95
93.1%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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). |
| Arm/Group Title | Investigation Group |
|---|---|
| Arm/Group Description | Subjects underwent Interbody Fusion using the Graft Containment Device with supplemental fixation. |
| Measure Participants | 102 |
| Count of Participants [Participants] |
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Investigation Group |
|---|---|
| Arm/Group Description | This is a single-arm investigation. All subjects were treated with the SIFS device filled with bone graft. Posterior fixation required. |
| Measure Participants | 96 |
| Count of Participants [Participants] |
92
90.2%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Compared the number of participants working at baseline to the number of participants working at 24-months post-op. |
| Arm/Group Title | Participants Working at Baseline | Participants Working at 24-Month Visit |
|---|---|---|
| Arm/Group Description | This is a single-arm investigation. All subjects were treated with the SIFS device filled with bone graft. Posterior fixation required. | This is a single-arm Investigation. All subjects were treated with the SIFS device. Posterior fixation required. |
| Measure Participants | 102 | 96 |
| Count of Participants [Participants] |
54
52.9%
|
46
NaN
|
| Title | Number of Participants With Narcotic Pain Medication |
|---|---|
| Description | Narcotic pain medication use for back pain was compared to baseline. |
| Time Frame | 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Investigation Group |
|---|---|
| Arm/Group Description | This is a single-arm investigation. All subjects were treated with the SIFS device filled with bone graft. Posterior fixation required. |
| Measure Participants | 96 |
| Count of Participants [Participants] |
17
16.7%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Investigation Group |
|---|---|
| Arm/Group Description | This is a single-arm investigation. All subjects were treated with the SIFS device filled with bone graft. Posterior fixation required. |
| Measure Participants | 102 |
| Mean (Standard Deviation) [cubic centimeters of blood (cc)] |
137.3
(217.4)
|
| Title | Duration of Surgery |
|---|---|
| Description | Operative time (from incision to closure). |
| Time Frame | At the conclusion of the surgical procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Investigation Group |
|---|---|
| Arm/Group Description | This is a single-arm investigation. All subjects were treated with the SIFS device filled with bone graft. Posterior fixation required. |
| Measure Participants | 102 |
| Mean (Standard Deviation) [hours] |
2.6
(0.9)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Investigation Group |
|---|---|
| Arm/Group Description | This is a single-arm investigation. All subjects were treated with the SIFS device filled with bone graft. Posterior fixation required. |
| Measure Participants | 102 |
| Mean (Standard Deviation) [days] |
2.3
(1.2)
|
| Title | Patient Satisfaction |
|---|---|
| Description | Subjects rating their procedure as excellent or good |
| Time Frame | 24-Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Investigation Group |
|---|---|
| Arm/Group Description | This is a single-arm investigation. All subjects were treated with the SIFS device filled with bone graft. Posterior fixation required. |
| Measure Participants | 96 |
| Count of Participants [Participants] |
88
86.3%
|
Adverse Events
| Time Frame | From Intraoperative through 24-months postoperative. | |
|---|---|---|
| Adverse Event Reporting Description | All events were adjudicated by independent spine surgeon committee (not investigators). | |
| Arm/Group Title | Investigation Group | |
| Arm/Group Description | This is a single-arm investigation. All subjects were treated with the SIFS device filled with bone graft. Posterior fixation required. | |
All Cause Mortality |
||
| Investigation Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/102 (1%) | |
Serious Adverse Events |
||
| Investigation Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 12/102 (11.8%) | |
| Musculoskeletal and connective tissue disorders | ||
| Contralateral leg pain | 1/102 (1%) | 1 |
| Back and leg pain | 1/102 (1%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Pulmonary thromboembolism | 1/102 (1%) | 1 |
| Surgical and medical procedures | ||
| Stenosis | 4/102 (3.9%) | 4 |
| Dural leak | 1/102 (1%) | 1 |
| Hematoma | 1/102 (1%) | 1 |
| Adjacent level disease | 2/102 (2%) | 2 |
| Device improper placement | 1/102 (1%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Investigation Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/102 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Rose Griffith, Sr. Director, Clinical Affairs |
|---|---|
| Organization | Spineology |
| Phone | 6512568503 |
| Rgriffith@spineology.com |
- 62-180