Lumbar Degenerative Disc Disease
Conditions
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.
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.
Interventions
DEVICESIFS 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.
Sponsors
Spineology, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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: 1. 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). 2. 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). 3. Fusion -- Defined as bridging bone demonstrated on computed tomography (CT) scan 4. 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
| Number of Participants Working | 24 months | Compared the number of participants working at 24-months to number of subjects working at baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 102 |
| Total | 102 |
Baseline characteristics
| Characteristic | SIFS Graft Containment Device |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 31 Participants |
| Age, Categorical Between 18 and 65 years | 71 Participants |
| Age, Continuous | 57.0 Years STANDARD_DEVIATION 12 |
| Back Function Status | 53.60 units on a scale STANDARD_DEVIATION 11.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 98 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Left Leg Pain Status | 52.9 units on a scale STANDARD_DEVIATION 32.4 |
| Low Back Pain Status | 74.1 units on a scale STANDARD_DEVIATION 16.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 96 Participants |
| Region of Enrollment United States | 102 participants |
| Right Leg Pain Status | 42.9 units on a scale STANDARD_DEVIATION 34.1 |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 102 |
| other Total, other adverse events | 0 / 102 |
| serious Total, serious adverse events | 12 / 102 |
Outcome results
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: 1. 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). 2. 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). 3. Fusion -- Defined as bridging bone demonstrated on computed tomography (CT) scan 4. 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
Population: A total of 96 subjects achieved a 24-month exam with complete data (data and CT imaging).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SIFS Investigation Gp | Overall Success | 71 Participants |
Other Pre-specified
Blood Loss
Blood loss (cc) reported for the surgical procedure.
Time frame: At the conclusion of the surgical procedure, an average of 2.6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIFS Investigation Gp | Blood Loss | 137.3 cubic centimeters of blood (cc) | Standard Deviation 217.4 |
Other Pre-specified
Duration of Hospital Stay
Number of days subject was in the hospital (from admission to discharge).
Time frame: From admission through discharge, an average of 2 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIFS Investigation Gp | Duration of Hospital Stay | 2.3 days | Standard Deviation 1.2 |
Other Pre-specified
Duration of Surgery
Operative time (from incision to closure).
Time frame: At the conclusion of the surgical procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIFS Investigation Gp | Duration of Surgery | 2.6 hours | Standard Deviation 0.9 |
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.
Time frame: 24 months
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIFS Investigation Gp | Mean Back Function Score at 24-months Post-operative | 21.0 score on a scale | Standard Deviation 19.3 |
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.
Time frame: 24 Months
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIFS Investigation Gp | Mean Left Leg Pain Score at 24-months Post-operative | 13.2 units on a scale | Standard Deviation 22.6 |
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.
Time frame: 24 months
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIFS Investigation Gp | Mean Low Back Pain Score at 24-months Post-operative | 21.8 units on a scale | Standard Deviation 24.5 |
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.
Time frame: 24 months
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIFS Investigation Gp | Mean Right Leg Pain Score at 24-months Post-operative | 10.5 units on a scale | Standard Deviation 19.5 |
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).
Time frame: Intra-Op through 24-month interval
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SIFS Investigation Gp | Number of Participants Experiencing a Device-Related Serious Adverse Event | 0 Participants |
Other Pre-specified
Number of Participants With a Neurological Maintenance or Improvement
Rate of subjects that were neurologically improved or maintained compared to baseline
Time frame: 24 months
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SIFS Investigation Gp | Number of Participants With a Neurological Maintenance or Improvement | 92 Participants |
Other Pre-specified
Number of Participants With Bridging Bone Presence
Bridging bone demonstrated on CT scan. Independent Board-certified radiologists determine fusion status.
Time frame: 24 months
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SIFS Investigation Gp | Number of Participants With Bridging Bone Presence | 95 Participants |
Other Pre-specified
Number of Participants With Narcotic Pain Medication
Narcotic pain medication use for back pain was compared to baseline.
Time frame: 24 Months
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SIFS Investigation Gp | Number of Participants With Narcotic Pain Medication | 17 Participants |
Other Pre-specified
Number of Participants Working
Compared the number of participants working at 24-months to number of subjects working at baseline
Time frame: 24 months
Population: Compared the number of participants working at baseline to the number of participants working at 24-months post-op.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SIFS Investigation Gp | Number of Participants Working | 54 Participants |
| Participants Working at 24-Month Visit | Number of Participants Working | 46 Participants |
Other Pre-specified
Patient Satisfaction
Subjects rating their procedure as excellent or good
Time frame: 24-Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SIFS Investigation Gp | Patient Satisfaction | 88 Participants |