Spineology Clinical Outcomes Trial: An IDE Investigation

NCT02347410 | Completed Results DMC

• 1 other identifier: 62-180
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 10

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.

Conditions

Lumbar Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Other Outcomes (13)

• Mean Low Back Pain Score at 24-months Post-operative

  24 months

• Mean Back Function Score at 24-months Post-operative

  24 months

• Mean Right Leg Pain Score at 24-months Post-operative

  24 months

Study Arms (1)

Investigation Group

OTHER

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

Interventions

SIFS graft containment device DEVICE

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.

Also known as: SIFS mesh

Investigation Group

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Spineology, Inc: lead

Study Sites (10)

Florida Orthopaedic Associates

DeLand, Florida, 32720, United States

Location

Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States

Location

Thibodaux Regional Medical Center

Thibodaux, Louisiana, 70901, United States

Location

Georgetown University Hospital

Clinton, Maryland, 20735, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Sports Medicine North

Peabody, Massachusetts, 01960, United States

Location

Bronson Healthcare Methodist Hospital - Neuroscience Center

Kalamazoo, Michigan, 39007, United States

Location

Mayo Clinic Hospital - College of Medicine

Rochester, Minnesota, 55905, United States

Location

University at Buffalo/SUNY

Buffalo, New York, 14203, United States

Location

University of Vermont Medical Center

South Burlington, Vermont, 05403, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Limitations and Caveats

By design, this was a non-randomized trial; all subjects enrolled and treated in this performance goal investigation received the study device.

Results Point of Contact

• Title: Rose Griffith, Sr. Director, Clinical Affairs
• Organization: Spineology

Rgriffith@spineology.com

6512568503

Study Officials

• Donald Erickson, M.D.

  Retired

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 27, 2015
• Study Start: January 22, 2015
• Primary Completion: January 22, 2020
• Study Completion: March 4, 2020
• Last Updated: October 20, 2021
• Results First Posted: October 20, 2021

Record last verified: 2021-10

Locations

US (10)