OptiMesh® for Lumbar Interbody Fusion Trial (OLIF)

Degeneration of Lumbar Intervertebral Disc Clinical Trial

— OLIF  

Official title:

OptiMesh® for Lumbar Interbody Fusion Trial (OLIF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00764491
• Other study ID #: G030106
• Status: Completed
• Phase: N/A
• Start date: July 2003
• Est. completion date: May 2013

Study information

• Verified date: August 2021
• Source: Spineology, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: May 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Degeneration of Lumbar Intervertebral Disc
• Intervertebral Disc Degeneration

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Rush-Copley Medical Center	Aurora	Illinois
United States	Fletcher-Allen Health Center	Burlington	Vermont
United States	Kootenai Medical Center	Coeur d'Alene	Idaho
United States	McLeod Health	Florence	South Carolina
United States	Olympia Medical Center	Los Angeles	California
United States	Alegent-Health Immanuel Medical Center	Omaha	Nebraska
United States	St. Charles Hospital	Port Jefferson	New York
United States	Methodist Hospital	Saint Louis Park	Minnesota
United States	St. Mary's Christus Hospital	Shreveport	Louisiana
United States	Providence Hospitals and Medical Center	Southfield	Michigan
United States	Lakeview Hospital	Stillwater	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Spineology, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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

External Links

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