A Prospective, Randomized, Multi-center Study to Assess the Performance of MagnEtOs Flex Matrix Compared to Cellular Allograft in Patients Undergoing up to Four-level Instrumented poSterolatEral Lumbar/Thoraco-lumbar Fusion (PLF)

Research Source1 site in 1 country30 target enrollmentJune 11, 2024

ConditionsDegenerative Disc Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Degenerative Disc Disease
Sponsor: Research Source
Enrollment: 30
Locations: 1
Primary Endpoint: Posterolateral side fusion
Status: Enrolling By Invitation
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to demonstrate the performance of MagnetOs Flex Matrix in patients with leg pain and/or back pain.

Detailed Description

This is a prospective, randomized, multi-center study that intends to demonstrate the performance of MagnetOs Flex Matrix compared to Cellular Allograft in patients with leg pain and/or back pain requiring up to four-level instrumented PLF surgery.

Registry

clinicaltrials.gov

Start Date

June 11, 2024

End Date

May 1, 2027

Last Updated

8 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Research Source

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient is able to read/be read, understand, and provide written informed consent and has signed the IRB approved informed consent.
•Male or female patient ≥ 18 years old.
•Patients with leg pain, and/or back pain requiring up to four-level instrumented posterolateral lumbar/thoraco-lumbar fusion (T11 - S1).
•Failed conservative treatment (physical therapy, bed rest, medications, spinal injections, manipulations, or transcutaneous electrical nerve stimulation) for a minimum period of 3 months prior to study enrollment.

Exclusion Criteria

•Requires greater than four-level fusion or expected to need secondary intervention within one year following surgery.
•Had prior PLF fusion or attempted PLF fusion at the involved levels.
•Had previous decompression at the involved levels.
•Women who are or intend to become pregnant within the next 12 months.
•To treat conditions in which general bone grafting is not advisable.
•In conditions where the surgical site may be subjected to excessive impact or stresses, including those beyond the load strength of fixation hardware (e.g., defect site stabilization is not possible).
•In case of significant vascular impairment proximal to the graft site.
•In case of severe metabolic or systemic bone disorders (e.g., osteogenesis imperfecta or Paget's Disease) that affect bone or wound healing.
•In case of acute and chronic infections in the operated area (soft tissue infections; inflammation, bacterial bone diseases; osteomyelitis).
•When intraoperative soft tissue coverage is not planned or possible.

Outcomes

Primary Outcomes

Posterolateral side fusion

Time Frame: 12 months post surgery

The percentage of the posterolateral sides with bridging bone for the MagnetOs Flex Matrix and control treatments using CT-scans and determined by evidence of bridging trabeculae or continuous bony connection between superior and inferior transverse processes.

Secondary Outcomes

Clinical outcome via neck visual analog scale (VAS)(12 months post-surgery)
Posterolateral lumbar/thoraco-lumbar fusion(6 months post surgery)
Clinical outcome via Oswestry Low Back Pain Disability Questionnaire (ODI)(12 months post-surgery)
Secondary Surgical Interventions (SSI's)(12 months post-surgery)