Spineology Clinical Outcomes Trial: An Investigation Device Exempt (IDE) Performance Goal Clinical Investigation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lumbar Degenerative Disc Disease
- Sponsor
- Spineology, Inc
- Enrollment
- 102
- Locations
- 10
- Primary Endpoint
- Overall Success
- Status
- Completed
- Last Updated
- 4 years ago
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.
Investigators
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;
Outcomes
Primary Outcomes
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.