Spineology Clinical Outcomes Trial: An IDE Investigation

Spineology, Inc102 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

102

Conditions

Lumbar Degenerative Disc Disease

Interventions

SIFS graft containment deviceDEVICE

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (10)

Florida Orthopaedic Associates

DeLand, Florida, United States

Spine Institute of Louisiana

Shreveport, Louisiana, United States

Thibodaux Regional Medical Center

Thibodaux, Louisiana, United States

Outcomes

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

Data from ClinicalTrials.gov

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