Status:
COMPLETED
OptiMesh® for Lumbar Interbody Fusion Trial (OLIF)
Lead Sponsor:
Spineology, Inc
Conditions:
Degeneration of Lumbar Intervertebral Disc
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 inte...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT00764491
Start Date
July 1 2003
End Date
May 1 2013
Last Update
September 16 2021
Active Locations (11)
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1
Olympia Medical Center
Los Angeles, California, United States, 90036
2
Kootenai Medical Center
Coeur d'Alene, Idaho, United States, 83814
3
Rush-Copley Medical Center
Aurora, Illinois, United States, 60504
4
St. Mary's Christus Hospital
Shreveport, Louisiana, United States, 71101