OptiMesh® for Lumbar Interbody Fusion Trial (OLIF) (OLIF)

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.

Study Overview

• Status: Completed
• Conditions: Degeneration of Lumbar Intervertebral Disc
• Intervention / Treatment: Device: OptiMesh 1500S; Device: Structural Allograft Spacer

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.

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90036
      • Olympia Medical Center
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • Kootenai Medical Center
  • Illinois
    • Aurora, Illinois, United States, 60504
      • Rush-Copley Medical Center
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • St. Mary's Christus Hospital
  • Michigan
    • Southfield, Michigan, United States, 48075
      • Providence Hospitals and Medical Center
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55426
      • Methodist Hospital
    • Stillwater, Minnesota, United States, 55082
      • Lakeview Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68122
      • Alegent-Health Immanuel Medical Center
  • New York
    • Port Jefferson, New York, United States, 11777
      • St. Charles Hospital
  • South Carolina
    • Florence, South Carolina, United States, 29506
      • McLeod Health
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Fletcher-Allen Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: OptiMesh; OLIF
Active Comparator: Structural Allograft Spacer; Structural Allograft Spacer with pedicle screws.	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.; Other Names: Allograft bone spacer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Low Back Pain Score at 24-months Compared to Pre-op	A Visual Analog Scale (VAS) score was used to evaluate a subject's level of pain. The VAS is a 10 cm pain scale where a score of "0" represents "No Pain" and a score of "10" represents the "Worst Possible" pain. The magnitude of change in the 24-month score compared to the baseline score is calculated. A clinically meaningful change is defined as a 2 unit (cm) reduction at 24-months when compared to pre-op.	24 month
Mean Change in Back Function Score at 24-months Compared to Pre-op	A subject's back function was assessed by the Oswestry Disability Index (ODI). The ODI is a 10 question survey that evaluates the degree of functional impairment. Completion of the survey yields a score from "0" to "100" points. A score of "0" represents "No disability" and "100" represents "Total disability". The magnitude of change between the two timepoints is reported. A clinically meaningful improvement is defined as a 15 point reduction at 24-months compared to the pre-op score.	24 month
Number of Participants Determined to be a Fusion Success at 24 Months Post-operative	Fusion Success is defined as <5 degrees angulation, <10% translation, and presence of bridging bone on CT.	24 month
Number of Participants With a Serious Device and Procedure Related Adverse Event	The rate of serious device and procedure related adverse events are compared between the control and treatment arm from intraoperative through 24 months of follow-up.	From Intra-op through the 24-month visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Right Leg Pain Score--Change From Preop at the 24-month Timepoint	Right leg pain assessed by subject response on Visual Analog Scale (0-10 cm) where "0" represents "No pain" and "10" represents "Worst pain". The magnitude of change at 24-months compared to baseline is reported. A clinically relevant improvement is defined as a 2 cm reduction at 24-months compared to pre-op.	24-month visit
Left Leg Pain--Change From Preop at the 24-month Timepoint	Left leg pain assessed by subject response on Visual Analog Scale (0-10cm) where "0" represents "No left leg pain" and "10" represents "Worst Pain". The magnitude of change at 24-months post-operative compared to the baseline score is reported. A clinically relevant improvement is defined as a 2 cm reduction at 24-months compared to pre-op.	24-month visit
Number of Participants Rating Their Procedure as Very Satisfied or Somewhat Satisfied at 24-months Postoperative	Subjects were asked to rate their satisfaction with their surgical procedure as "Very Satisfied", "Somewhat Satisfied", "Somewhat Dissatisfied" or "Very Dissatisfied" with their procedure	24-month visit

Collaborators and Investigators

• Sponsor: Spineology, Inc
• Investigators: Principal Investigator: Martin Krag, MD, Fletcher-Allen Health Center

Publications and helpful links

Helpful Links

• Sponsor

Study record dates

Study Major Dates

• Study Start: July 1, 2003
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: October 1, 2008
• First Submitted That Met QC Criteria: October 1, 2008
• First Posted (Estimate): October 2, 2008

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Disc degeneration; DDD; Degenerative Disc Disease; Lumbar DDD; Interbody Fusion; Lumbar Interbody Fusion; IBF
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: G030106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No