Spineology Clinical Outcomes Trial: An IDE Investigation

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

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.

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.

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