NCT00764491

OptiMesh® for Lumbar Interbody Fusion Trial (OLIF)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Spineology, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to collect data to demonstrate the safety and effectiveness of the OptiMesh 1500S to contain and reinforce bone graft materials in patients with Degenerative Disc Disease (DDD) whose condition requires an interbody spinal fusion procedure combined with posterior fixation.

Detailed description

Seventy-six thousand posterior interbody fusions are performed annually in the U.S., and it has been estimated that at least 50% of those cases include supplemental posterior instrumentation. For interbody fusion with posterior fixation, spine surgeons currently place structural intervertebral spacers into the interbody space. These spacers may be pre-shaped devices constructed of allograft (cortical bone dowels or femoral rings) or non-metallic, radiolucent materials, or metallic cage devices. Autogenous bone graft and blood components (marrow, blood) are often added. Use of morselized bone graft in orthopedic procedures is desirable because it is more rapidly incorporated during the course of bone healing. If the morselized graft pack can be effectively contained in the interbody space, the graft material can function as a structural spacer to provide anterior column support. Contained graft material can be tightly packed within the mesh to increase the graft's compressive strength. Unlike pre-shaped cortical grafts, the morselized pack conforms intimately to the host bone at the surgical site, ensuring good vascularization potential and reducing the osteoblast jumping distance for osteogenesis. In addition, the solidly packed graft retains intra-pack porosity, ensuring an osteoconductive scaffold to facilitate vascular and bony ingrowth. It would be desirable to minimize autograft use because of associated post-op pain, to optimize contact between allograft and host bone, and to permit the surgeon to place or construct an effective structural intervertebral spacer with only minimal neural retraction required. OptiMesh 1500S is intended to be used to contain the bone graft placed by spine surgeons into the interbody space to achieve spinal intervertebral body fusion. OptiMesh 1500S enables the use of morselized bone graft materials in spine fusion procedures instead of solid allograft materials, such as cortical bone dowels or femoral rings, or rigid synthetic materials. In addition, the OptiMesh instrument system allows the surgeon to perform an interbody fusion through a small portal and to complete the entire fusion procedure from a posterior approach instead of a 360 degree anterior/ posterior procedure, which is often the case with the use of cages. The minimal access portal utilized for OptiMesh filling allows the device to be placed via a unilateral transforaminal or translaminar approach, versus the often-used bilateral approach required for many cages and cortical spacers. This flexibility permits the surgeon to adapt the surgical approach to the local anatomy of the patient.

Conditions

• Degeneration of Lumbar Intervertebral Disc

Interventions

Type	Name	Description
DEVICE	Structural Allograft Spacer	Following disc space preparation the spacer is placed in accordance with cleared labeling and supplemental instrumentation is provided as an adjunct to fixation.
DEVICE	OptiMesh 1500S	Following disc space preparation the OptiMesh is deployed and filled in accordance with study surgical technique and supplemental instrumentation is provided as an adjunct to fixation.

Timeline

• Start date: 2003-07-01
• Primary completion: 2012-11-01
• Completion: 2013-05-01
• First posted: 2008-10-02
• Last updated: 2021-09-16
• Results posted: 2021-09-16

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study