Clinical trial NCT00764491: OptiMesh® for Lumbar Interbody Fusion Trial (OLIF)
Official title: OptiMesh® for Lumbar Interbody Fusion Trial (OLIF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degeneration of Lumbar Intervertebral Disc
Keywords: Degenerative Disc Disease
DDD
Lumbar DDD
Disc degeneration
Interbody Fusion
Lumbar Interbody Fusion
IBF
Lead sponsor: Spineology, Inc
Sponsor class: INDUSTRY
First posted: 2008-10-02
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean Change in Low Back Pain Score at 24-months Compared to Pre-op
timeFrame: 24 month
measure: Mean Change in Back Function Score at 24-months Compared to Pre-op
timeFrame: 24 month
measure: Number of Participants Determined to be a Fusion Success at 24 Months Post-operative
timeFrame: 24 month
measure: Number of Participants With a Serious Device and Procedure Related Adverse Event
timeFrame: From Intra-op through the 24-month visit
Secondary outcomes:
measure: Right Leg Pain Score--Change From Preop at the 24-month Timepoint
timeFrame: 24-month visit
measure: Left Leg Pain--Change From Preop at the 24-month Timepoint
timeFrame: 24-month visit
measure: Number of Participants Rating Their Procedure as Very Satisfied or Somewhat Satisfied at 24-months Postoperative
timeFrame: 24-month visit
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Olympia Medical Center
state: California
city: Coeur d'Alene
country: United States
facility: Kootenai Medical Center
state: Idaho
city: Aurora
country: United States
facility: Rush-Copley Medical Center
state: Illinois
city: Shreveport
country: United States
facility: St. Mary's Christus Hospital
state: Louisiana
city: Southfield
country: United States
facility: Providence Hospitals and Medical Center
state: Michigan
city: Saint Louis Park
country: United States
facility: Methodist Hospital
state: Minnesota
city: Stillwater
country: United States
facility: Lakeview Hospital
state: Minnesota
city: Omaha
country: United States
facility: Alegent-Health Immanuel Medical Center
state: Nebraska
city: Port Jefferson
country: United States
facility: St. Charles Hospital
state: New York
city: Florence
country: United States
facility: McLeod Health
state: South Carolina
city: Burlington
country: United States
facility: Fletcher-Allen Health Center
state: Vermont
Study officials:
affiliation: Fletcher-Allen Health Center
name: Martin Krag, MD
role: PRINCIPAL_INVESTIGATOR
References: