OptiMesh® for Lumbar Interbody Fusion Trial (OLIF)
OLIF
1 other identifier
interventional
156
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2003
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 1, 2008
CompletedFirst Posted
Study publicly available on registry
October 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
September 16, 2021
CompletedSeptember 16, 2021
August 1, 2021
9.3 years
October 1, 2008
March 23, 2021
August 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
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
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
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 Outcomes (3)
Right Leg Pain Score--Change From Preop at the 24-month Timepoint
24-month visit
Left Leg Pain--Change From Preop at the 24-month Timepoint
24-month visit
Number of Participants Rating Their Procedure as Very Satisfied or Somewhat Satisfied at 24-months Postoperative
24-month visit
Study Arms (2)
Optimesh 1500S
EXPERIMENTALOptiMesh 1500S, filled with a mixture of demineralized bone matrix (DBM) and cortico-cancellous bone, placed into the interbody space from the posterior approach and supplemental pedicle screws.
Structural Allograft Spacer
ACTIVE COMPARATORStructural Allograft Spacer with pedicle screws.
Interventions
Following disc space preparation the spacer is placed in accordance with cleared labeling and supplemental instrumentation is provided as an adjunct to fixation.
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Spineology, Inclead
Study Sites (11)
Olympia Medical Center
Los Angeles, California, 90036, United States
Kootenai Medical Center
Coeur d'Alene, Idaho, 83814, United States
Rush-Copley Medical Center
Aurora, Illinois, 60504, United States
St. Mary's Christus Hospital
Shreveport, Louisiana, 71101, United States
Providence Hospitals and Medical Center
Southfield, Michigan, 48075, United States
Methodist Hospital
Saint Louis Park, Minnesota, 55426, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Alegent-Health Immanuel Medical Center
Omaha, Nebraska, 68122, United States
St. Charles Hospital
Port Jefferson, New York, 11777, United States
McLeod Health
Florence, South Carolina, 29506, United States
Fletcher-Allen Health Center
Burlington, Vermont, 05401, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
1. This investigation was terminated early for protracted enrollment. 2. Multiple subjects were lost to follow-up at the 24-month visit.
Results Point of Contact
- Title
- Rose Griffith, Sr. Director, Clinical Affairs
- Organization
- Spineology
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Krag, MD
Fletcher-Allen Health Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2008
First Posted
October 2, 2008
Study Start
July 1, 2003
Primary Completion
November 1, 2012
Study Completion
May 1, 2013
Last Updated
September 16, 2021
Results First Posted
September 16, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share