Degeneration of Lumbar Intervertebral DiscOLIFNCT00764491
OptiMesh® for Lumbar Interbody Fusion Trial (OLIF)
A study testing Structural Allograft Spacer and OptiMesh 1500S in people with Degeneration of Lumbar Intervertebral Disc, run by Spineology, Inc at 11 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degeneration of Lumbar Intervertebral Disc
- What is being tested?
- Structural Allograft Spacer and OptiMesh 1500S
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 11 sitesUnited States
- Study dates
- Jul 2003to May 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Rush-Copley Medical Center
Aurora, Illinois, 60504
Fletcher-Allen Health Center
Burlington, Vermont, 05401
Kootenai Medical Center
Coeur d'Alene, Idaho, 83814
McLeod Health
Florence, South Carolina, 29506
Olympia Medical Center
Los Angeles, California, 90036
Alegent-Health Immanuel Medical Center
Omaha, Nebraska, 68122
St. Charles Hospital
Port Jefferson, New York, 11777
Methodist Hospital
Saint Louis Park, Minnesota, 55426
St. Mary's Christus Hospital
Shreveport, Louisiana, 71101
Providence Hospitals and Medical Center
Southfield, Michigan, 48075
Lakeview Hospital
Stillwater, Minnesota, 55082
About this study
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.
Read the 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 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.
- Being tested
- Structural Allograft Spacer, OptiMesh 1500S
- Keywords
- Degenerative Disc Disease, DDD, Lumbar DDD, Disc degeneration, Interbody Fusion, Lumbar Interbody Fusion, IBF
- Medical subject headings
- Intervertebral Disc Degeneration, Dowling-Degos Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structural Allograft SpacerDevice
Also called Allograft bone 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 1500SDevice
Also called OptiMesh, OLIF
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.
| Study group | Role | What they receive |
|---|---|---|
| Optimesh 1500S | Experimental | OptiMesh 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. Receives: Device: OptiMesh 1500S |
| Structural Allograft Spacer | Active comparator | Structural Allograft Spacer with pedicle screws. Receives: Device: Structural Allograft Spacer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Intra-op through the 24-month visit
Secondary outcomes (3)
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.
Measured: 24-month visit
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.
Measured: 24-month visit
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
Measured: 24-month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startJul 2003
- Primary completionNov 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Degeneration of Lumbar Intervertebral DiscStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spineology, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Krag, MD, Principal investigator, Fletcher-Allen Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764491
- Sponsor's protocol ID
- G030106
- Acronym
- OLIF
- Status last verified
- Aug 2021
- First submitted
- 1 Oct 2008
- Last updated
- 16 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OptiMesh® for Lumbar Interbody Fusion Trial (OLIF)
- ClinicalTrials.gov ID
- NCT00764491
- Acronym / sponsor ID
- OLIF / G030106
- Keywords
- Degenerative Disc Disease, DDD, Lumbar DDD, Disc degeneration, Interbody Fusion, Lumbar Interbody Fusion, IBF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Spineology, IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Nov 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 2 Oct 2008 (estimated)
- Results
- Posted 16 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimesh 1500S | Experimental | Device: OptiMesh 1500SOptiMesh 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 comparator | Device: Structural Allograft SpacerStructural Allograft Spacer with pedicle screws. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structural Allograft SpacerAlso: Allograft bone spacerFollowing disc space preparation the spacer is placed in accordance with cleared labeling and supplemental instrumentation is provided as an adjunct to fixation. | Device | Structural Allograft Spacer |
| OptiMesh 1500SAlso: OptiMesh, OLIFFollowing 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. | Device | Optimesh 1500S |
Primary outcome
Mean Change in Low Back Pain Score at 24-months Compared to Pre-op
Time frame: 24 month
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.
Mean Change in Back Function Score at 24-months Compared to Pre-op
Time frame: 24 month
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.
Number of Participants Determined to be a Fusion Success at 24 Months Post-operative
Time frame: 24 month
Fusion Success is defined as <5 degrees angulation, <10% translation, and presence of bridging bone on CT.
Number of Participants With a Serious Device and Procedure Related Adverse Event
Time frame: From Intra-op through the 24-month visit
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.
3 secondary outcomes
Right Leg Pain Score--Change From Preop at the 24-month Timepoint
Time frame: 24-month visit
Left Leg Pain--Change From Preop at the 24-month Timepoint
Time frame: 24-month visit
Number of Participants Rating Their Procedure as Very Satisfied or Somewhat Satisfied at 24-months Postoperative
Time frame: 24-month visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- SponsorLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Krag, MD principal investigator
Fletcher-Allen Health Center
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structural Allograft Spacer and OptiMesh 1500S in people with Degeneration of Lumbar Intervertebral Disc, run by Spineology, Inc at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Low Back Pain Score at 24-months Compared to Pre-op (time frame: 24 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.