Spineology Clinical Outcomes Trial: An IDE Investigation

Not Applicable

Completed

• Conditions: Lumbar Degenerative Disc Disease
• Interventions: Device: SIFS graft containment device

• Registration Number: NCT02347410
• Lead Sponsor: Spineology, Inc

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.

Study Timeline

• Study First Submitted: 2015-01-13
• Study First Submitted QC: 2015-01-21
• Study Start: 2015-01-22
• Study First Posted: 2015-01-27
• Primary Completion: 2020-01-22
• Study Completion: 2020-03-04
• Results First Submitted: 2021-03-23
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-06
• Last Update Submitted: 2021-10-06
• Results First Posted: 2021-10-20
• Last Update Posted: 2021-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Investigation Group	SIFS graft containment device	This is a single-arm investigation. All subjects were treated with the SIFS device filled with bone graft. Posterior fixation required.

Primary Outcome Measures

Name	Time	Method
Overall Success	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.

Trial Locations

Locations (10)

Georgetown University Hospital; 🇺🇸 Clinton, Maryland, United States

Spine Institute of Louisiana; 🇺🇸 Shreveport, Louisiana, United States

Florida Orthopaedic Associates; 🇺🇸 DeLand, Florida, United States

Thibodaux Regional Medical Center; 🇺🇸 Thibodaux, Louisiana, United States

Mayo Clinic Hospital - College of Medicine; 🇺🇸 Rochester, Minnesota, United States

Sports Medicine North; 🇺🇸 Peabody, Massachusetts, United States

University at Buffalo/SUNY; 🇺🇸 Buffalo, New York, United States

University of Vermont Medical Center; 🇺🇸 South Burlington, Vermont, United States

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Bronson Healthcare Methodist Hospital - Neuroscience Center; 🇺🇸 Kalamazoo, Michigan, United States