OptiMesh® for Lumbar Interbody Fusion Trial (OLIF)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Degeneration of Lumbar Intervertebral Disc

Intervention / Treatment
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* Device: Structural Allograft Spacer
* Device: OptiMesh 1500S


Participation Criteria
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Eligibility Criteria
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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: instability as defined by >3 mm translation or ≥5º rotation of flexion/ extension; osteophyte formation of facet joints or vertebral endplates; decreased disc height, on average 2 mm, but dependent on spinal level; scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule; herniated nucleus pulposus; facet joint degeneration/changes; and/or 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optimesh 1500S<br>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<br>* 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.<br>* Other names: OLIF;|
| Active Comparator: Structural Allograft Spacer<br>Structural Allograft Spacer with pedicle screws. | Device: Structural Allograft Spacer<br>* Following disc space preparation the spacer is placed in accordance with cleared labeling and supplemental instrumentation is provided as an adjunct to fixation.<br>* Other names: Allograft bone spacer;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DDD, Degenerative Disc Disease, Lumbar DDD, Disc degeneration, Interbody Fusion, Lumbar Interbody Fusion, IBF