OptiMesh® for Lumbar Interbody Fusion Trial (OLIF)
Completed · Not applicable
Conditions studied: Degeneration of Lumbar Intervertebral Disc
In brief
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.
Key facts
- Study ID
- NCT00764491
- Run by
- Spineology, Inc
- People needed
- 156
- Starts
- 2003-07-01
- Expected to finish
- 2013-05-01
- Last updated by the study team
- 2021-09-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Olympia Medical Center — Los Angeles, California, United States
- Kootenai Medical Center — Coeur d'Alene, Idaho, United States
- Rush-Copley Medical Center — Aurora, Illinois, United States
- St. Mary's Christus Hospital — Shreveport, Louisiana, United States
- Providence Hospitals and Medical Center — Southfield, Michigan, United States
- Methodist Hospital — Saint Louis Park, Minnesota, United States
- Lakeview Hospital — Stillwater, Minnesota, United States
- Alegent-Health Immanuel Medical Center — Omaha, Nebraska, United States
- St. Charles Hospital — Port Jefferson, New York, United States
- McLeod Health — Florence, South Carolina, United States
- Fletcher-Allen Health Center — Burlington, Vermont, United States
Full record on ClinicalTrials.gov
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