Spineology Clinical Outcomes Trial: An IDE Investigation

Study Overview
=================
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.

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

Conditions
-----------------
Lumbar Degenerative Disc Disease

Intervention / Treatment
-----------------
* Device: SIFS graft containment device


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Investigation Group<br>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<br>* 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.<br>* Other names: SIFS mesh;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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: 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. | 24 months |