CompletedNCT02347410SCOUTUpdated Oct 20, 2021Results posted

Spineology Clinical Outcomes Trial: An IDE Investigation

An interventional study of SIFS graft containment device in Lumbar Degenerative Disc Disease, sponsored by Spineology, Inc. Completed at 10 sites in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-10-20.

Sponsored by Spineology, Inc · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 102
Allocation: Not applicable
Ages: 21 Years to 80 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Lumbar Degenerative Disc Disease

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Intervertebral Disc Degeneration 464

In context

Intervertebral Disc Degeneration

464 studies on the registry are indexed under Intervertebral Disc Degeneration; 98 are open to participants now.

This study's enrollment of 102 is above the median of 60 across 261 interventional studies indexed under Intervertebral Disc Degeneration.

Browse Intervertebral Disc Degeneration studies →

Lead sponsor

Spineology, Inc is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 80 Years
Sexes eligible: All
Accepts 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

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

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 102 participants (actual)

Study arms

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

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.
Also known as: SIFS mesh

What researchers measure

Primary outcomes

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

Other outcomes

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
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
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
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
Number of Participants With Bridging Bone Presence
Bridging bone demonstrated on CT scan. Independent Board-certified radiologists determine fusion status.
Time frame: 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).
Time frame: 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
Time frame: 24 months
Number of Participants Working
Compared the number of participants working at 24-months to number of subjects working at baseline
Time frame: 24 months
Number of Participants With Narcotic Pain Medication
Narcotic pain medication use for back pain was compared to baseline.
Time frame: 24 Months
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
Duration of Surgery
Operative time (from incision to closure).
Time frame: At the conclusion of the surgical procedure
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
Patient Satisfaction
Subjects rating their procedure as excellent or good
Time frame: 24-Months

Results

Posted Oct 20, 2021

Limitations and caveats

By design, this was a non-randomized trial; all subjects enrolled and treated in this performance goal investigation received the study device.

Participant flow

Participant flow — Overall Study
Milestone	SIFS Graft Containment Device
Started	102
Completed	98
Not completed	4

Outcome measures

PrimaryOverall 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
Reported as:: Count of participants · Participants

Overall Success
Participants	SIFS Investigation Gp
Overall Success	71

Other pre-specifiedMean 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
Reported as:: Mean · units on a scale

Mean Low Back Pain Score at 24-months Post-operative
units on a scale	Investigation Group
Mean Low Back Pain Score at 24-months Post-operative	21.8 ± 24.5

Other pre-specifiedMean 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
Reported as:: Mean · score on a scale

Mean Back Function Score at 24-months Post-operative
score on a scale	Investigation Group
Mean Back Function Score at 24-months Post-operative	21.0 ± 19.3

Other pre-specifiedMean Right Leg Pain Score at 24-months Post-operative

Time frame:: 24 months
Reported as:: Mean · units on a scale

Mean Right Leg Pain Score at 24-months Post-operative
units on a scale	SIFS Graft Containment Device
Mean Right Leg Pain Score at 24-months Post-operative	10.5 ± 19.5

Other pre-specifiedMean Left Leg Pain Score at 24-months Post-operative

Time frame:: 24 Months
Reported as:: Mean · units on a scale

Mean Left Leg Pain Score at 24-months Post-operative
units on a scale	SIFS Graft Containment Device
Mean Left Leg Pain Score at 24-months Post-operative	13.2 ± 22.6

Other pre-specifiedNumber of Participants With Bridging Bone Presence

Bridging bone demonstrated on CT scan. Independent Board-certified radiologists determine fusion status.

Time frame:: 24 months
Reported as:: Count of participants · Participants

Number of Participants With Bridging Bone Presence
Participants	SIFS Graft Containment Device
Number of Participants With Bridging Bone Presence	95

Other pre-specifiedNumber 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
Reported as:: Count of participants · Participants

Number of Participants Experiencing a Device-Related Serious Adverse Event
Participants	Investigation Group
Number of Participants Experiencing a Device-Related Serious Adverse Event	0

Other pre-specifiedNumber of Participants With a Neurological Maintenance or Improvement

Rate of subjects that were neurologically improved or maintained compared to baseline

Time frame:: 24 months
Reported as:: Count of participants · Participants

Number of Participants With a Neurological Maintenance or Improvement
Participants	Investigation Group
Number of Participants With a Neurological Maintenance or Improvement	92

Other pre-specifiedNumber of Participants Working

Compared the number of participants working at 24-months to number of subjects working at baseline

Time frame:: 24 months
Reported as:: Count of participants · Participants

Number of Participants Working
Participants	Participants Working at Baseline	Participants Working at 24-Month Visit
Number of Participants Working	54	46

Other pre-specifiedNumber of Participants With Narcotic Pain Medication

Narcotic pain medication use for back pain was compared to baseline.

Time frame:: 24 Months
Reported as:: Count of participants · Participants

Number of Participants With Narcotic Pain Medication
Participants	Investigation Group
Number of Participants With Narcotic Pain Medication	17

Other pre-specifiedBlood Loss

Blood loss (cc) reported for the surgical procedure.

Time frame:: At the conclusion of the surgical procedure, an average of 2.6 hours
Reported as:: Mean · cubic centimeters of blood (cc)

Blood Loss
cubic centimeters of blood (cc)	Investigation Group
Blood Loss	137.3 ± 217.4

Other pre-specifiedDuration of Surgery

Operative time (from incision to closure).

Time frame:: At the conclusion of the surgical procedure
Reported as:: Mean · hours

Duration of Surgery
hours	Investigation Group
Duration of Surgery	2.6 ± 0.9

Other pre-specifiedDuration 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
Reported as:: Mean · days

Duration of Hospital Stay
days	Investigation Group
Duration of Hospital Stay	2.3 ± 1.2

Other pre-specifiedPatient Satisfaction

Subjects rating their procedure as excellent or good

Time frame:: 24-Months
Reported as:: Count of participants · Participants

Patient Satisfaction
Participants	Investigation Group
Patient Satisfaction	88

Adverse events

Collected over From Intraoperative through 24-months postoperative.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Investigation Group	1/102 (1%)	12/102 (11.8%)	0/102 (0%)

Most frequent serious events

Most frequent serious events
Event	Investigation Group
StenosisSurgical and medical procedures	4/102
Adjacent level diseaseSurgical and medical procedures	2/102
Dural leakSurgical and medical procedures	1/102
Pulmonary thromboembolismRespiratory, thoracic and mediastinal disorders	1/102
HematomaSurgical and medical procedures	1/102
Contralateral leg painMusculoskeletal and connective tissue disorders	1/102
Device improper placementSurgical and medical procedures	1/102
Back and leg painMusculoskeletal and connective tissue disorders	1/102

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	SIFS Graft Containment Device
<=18 years	0
Between 18 and 65 years	71
>=65 years	31

Age, Continuous
Age, Continuous(Years)	SIFS Graft Containment Device
Mean	57.0 ± 12.0

Sex: Female, Male
Sex: Female, Male(Participants)	SIFS Graft Containment Device
Female	51
Male	51

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	SIFS Graft Containment Device
Hispanic or Latino	4
Not Hispanic or Latino	98
Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	SIFS Graft Containment Device
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	4
White	96
More than one race	0
Unknown or Not Reported	2

Region of Enrollment
Region of Enrollment(participants)	SIFS Graft Containment Device
United States	102

Low Back Pain Status
Low Back Pain Status(units on a scale)	SIFS Graft Containment Device
Mean	74.1 ± 16.1

Right Leg Pain Status
Right Leg Pain Status(units on a scale)	SIFS Graft Containment Device
Mean	42.9 ± 34.1

2 further baseline measures are reported on the registry.

Study locations

10 sites

Florida Orthopaedic Associates
DeLand, Florida 32720, United States
Spine Institute of Louisiana
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

References and documents

Study documents

Protocol and statistical analysis plan · Aug 25, 2014

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02347410
Lead sponsor: Spineology, Inc
Responsible party: Sponsor
First posted: Jan 27, 2015
Start date: Jan 22, 2015
Primary completion: Jan 22, 2020
Completion: Mar 4, 2020
Results posted: Oct 20, 2021
Last update: Oct 20, 2021

Study contacts

Donald Erickson, M.D.

study chair · Retired

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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