OptiMesh® for Lumbar Interbody Fusion Trial (OLIF)

NCT ID: NCT00764491

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2013-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Optimesh 1500S

OptiMesh 1500S, filled with a mixture of demineralized bone matrix (DBM) and cortico-cancellous bone, placed into the interbody space from the posterior approach and supplemental pedicle screws.

Group Type: EXPERIMENTAL

OptiMesh 1500S

Intervention Type: DEVICE

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.

Structural Allograft Spacer

Structural Allograft Spacer with pedicle screws.

Group Type: ACTIVE_COMPARATOR

Structural Allograft Spacer

Intervention Type: DEVICE

Following disc space preparation the spacer is placed in accordance with cleared labeling and supplemental instrumentation is provided as an adjunct to fixation.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Allograft bone spacer; OptiMesh; OLIF

Eligibility Criteria

Inclusion Criteria

• Skeletally mature and be at least 18 years of age
• Have degenerative disc disease (DDD) requiring one level fusion between L2 and S1, with DDD confirmed by subject history, physical exam, and radiographic studies with one or more of the following factors:

1. instability as defined by >3 mm translation or ≥5º rotation of flexion/ extension;

2. osteophyte formation of facet joints or vertebral endplates;

3. decreased disc height, on average 2 mm, but dependent on spinal level;

4. scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule;

5. herniated nucleus pulposus;

6. facet joint degeneration/changes; and/or

7. vacuum phenomenon;

• Based on the VAS, subjects report pre-operative low back pain (>4 of 10) with duration of pain six-months or longer despite non-surgical treatment;
• Capable of understanding and signing the consent form; and
• Willing and able to comply with follow-up requirements

Exclusion Criteria

• A previous interbody fusion at the involved level;
• Greater than grade 2 spondylolisthesis;
• Systemic infection or active infection at the surgical site;
• Active malignancy;
• Body Mass Index of 40 or higher;
• Significant metabolic bone disease (e.g. osteoporosis or osteomalacia) to a degree that spinal instrumentation is contraindicated;
• Taking medications that may interfere with bone or soft tissue healing (e.g. long-term steroid use);
• Alcohol or drug abuse;
• Waddell Signs of Inorganic Behavior >3;
• Currently in litigation regarding a spinal condition;
• Known sensitivity to implant material;
• A prisoner;
• Pregnant or contemplating pregnancy during the 24-month follow-up period; and
• Enrolled in another concurrent clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spineology, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Krag, MD

Role: PRINCIPAL_INVESTIGATOR

Fletcher-Allen Health Center

Locations

Olympia Medical Center

Los Angeles, California, United States

Kootenai Medical Center

Coeur d'Alene, Idaho, United States

Rush-Copley Medical Center

Aurora, Illinois, United States

St. Mary's Christus Hospital

Shreveport, Louisiana, United States

Providence Hospitals and Medical Center

Southfield, Michigan, United States

Methodist Hospital

Saint Louis Park, Minnesota, United States

Lakeview Hospital

Stillwater, Minnesota, United States

Alegent-Health Immanuel Medical Center

Omaha, Nebraska, United States

St. Charles Hospital

Port Jefferson, New York, United States

McLeod Health

Florence, South Carolina, United States

Fletcher-Allen Health Center

Burlington, Vermont, United States

Countries

United States

Related Links

http://www.spineology.com/

Sponsor

Other Identifiers

G030106

Identifier Type: -

Identifier Source: org_study_id