N/A
Completed N=156
OptiMesh® for Lumbar Interbody Fusion Trial (OLIF)
Degeneration of Lumbar Intervertebral Disc
Source: ClinicalTrials.gov NCT00764491 ↗
Enrolled (actual)
156
Serious AEs
12.8%
Results posted
Sep 2021
Primary outcomePrimary: Mean Change in Low Back Pain Score at 24-months Compared to Pre-op — -4.0; -4.0 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Low Back Pain Score at 24-months Compared to Pre-op |
-4.0; -4.0 | — |
| PRIMARY Mean Change in Back Function Score at 24-months Compared to Pre-op |
-21.6; -18.4 | — |
| PRIMARY Number of Participants Determined to be a Fusion Success at 24 Months Post-operative |
71; 10 | — |
| PRIMARY Number of Participants With a Serious Device and Procedure Related Adverse Event |
14; 6 | — |
| SECONDARY Right Leg Pain Score--Change From Preop at the 24-month Timepoint |
-2.6; -2.0 | — |
| SECONDARY Left Leg Pain--Change From Preop at the 24-month Timepoint |
-2.5; -2.5 | — |
| SECONDARY Number of Participants Rating Their Procedure as Very Satisfied or Somewhat Satisfied at 24-months Postoperative |
37; 13 | — |
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:
- 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.
Data sourced from ClinicalTrials.gov (NCT00764491). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.