Lumbar Degenerative Disc DiseaseSCOUTNCT02347410

Spineology Clinical Outcomes Trial: An IDE Investigation

A study testing SIFS graft containment device in people with Lumbar Degenerative Disc Disease, run by Spineology, Inc at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 21 to 80 years
Conditions the study is for: Lumbar Degenerative Disc Disease
What is being tested?: SIFS graft containment device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: 10 sitesUnited States
Study dates: 22 Jan 2015to 4 Mar 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Brigham & Women's Hospital
Boston, Massachusetts, 02115
University at Buffalo/SUNY
Buffalo, New York, 14203
Georgetown University Hospital
Clinton, Maryland, 20735
Florida Orthopaedic Associates
DeLand, Florida, 32720
Bronson Healthcare Methodist Hospital - Neuroscience Center
Kalamazoo, Michigan, 39007
Sports Medicine North
Peabody, Massachusetts, 01960
Mayo Clinic Hospital - College of Medicine
Rochester, Minnesota, 55905
Spine Institute of Louisiana
Shreveport, Louisiana, 71101
University of Vermont Medical Center
South Burlington, Vermont, 05403
Thibodaux Regional Medical Center
Thibodaux, Louisiana, 70901

Other trials in United States

About this study

Official title: Spineology Clinical Outcomes Trial: An Investigation Device Exempt (IDE) Performance Goal Clinical Investigation

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: Lumbar Degenerative Disc Disease
Being tested: SIFS graft containment device
Medical subject headings: Intervertebral Disc Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SIFS graft containment deviceDevice
Also called SIFS mesh
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.

Study groups in NCT02347410
Study group	Role	What they receive
Investigation Group	Other	This is a single-arm investigation. All subjects were treated with the SIFS device filled with bone graft. Posterior fixation required. Receives: Device: SIFS graft containment device

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jan 20154 Mar 2020

First posted27 Jan 2015 (estimated)
Study start22 Jan 2015
Primary completion22 Jan 2020
Study completion4 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lumbar Degenerative Disc DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02347410
Sponsor's protocol ID: 62-180
Acronym: SCOUT
Status last verified: Oct 2021
First submitted: 13 Jan 2015
Last updated: 20 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
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Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
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ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
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Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Recruiting
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Degenerative Disc Disease, Spine Fusion

All Lumbar Degenerative Disc Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Spineology Clinical Outcomes Trial: An Investigation Device Exempt (IDE) Performance Goal Clinical Investigation
ClinicalTrials.gov ID: NCT02347410
Acronym / sponsor ID: SCOUT / 62-180
Conditions: Lumbar Degenerative Disc Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: Spineology, IncIndustry (pharma, biotech, devices)
Study start: 22 Jan 2015 (actual)
Primary completion: 22 Jan 2020 (actual)
Study completion: 4 Mar 2020 (actual)
First posted: 27 Jan 2015 (estimated)
Results: Posted 20 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Investigation Group	Other	Device: SIFS graft containment deviceThis is a single-arm investigation. All subjects were treated with the SIFS device filled with bone graft. Posterior fixation required.

Who may qualify

Ages: 21 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (15 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SIFS graft containment deviceAlso: SIFS meshThe 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.	Device	Investigation Group

Primary outcome

Overall Success
Time frame: 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.

Results and safety

Results posted to the registry on 20 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SIFS Graft Containment Device	102	98

Primary outcome: Overall Success

Time frame: 24 months. Count of participants. Unit: Participants

Measure	SIFS Investigation Gp n = 96
Value	71

Population analysed: A total of 96 subjects achieved a 24-month exam with complete data (data and CT imaging).

Adverse events

Time frame: From Intraoperative through 24-months postoperative.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Investigation Group	12 of 102 (11.8%)	0 of 102 (0%)	1 of 102

Limitations and caveats (from the sponsor): By design, this was a non-randomized trial; all subjects enrolled and treated in this performance goal investigation received the study device.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Lumbar Degenerative Disc Disease

Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Recruiting
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Degenerative Disc Disease, Spine Fusion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Donald Erickson, M.D. study chair

Retired

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SIFS graft containment device in people with Lumbar Degenerative Disc Disease, run by Spineology, Inc at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Success (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02347410.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.