Degenerative Disc DiseaseInQuNCT01746212
Outcomes of Degenerative Disc Disease Patients Treated With an Anterior-Only Fusion Using InQu Bone Graft
An observational study of Degenerative Disc Disease, run by Kansas Joint and Spine Institute at 2 sites in United States.
Trial summary
The purpose of this study is to report the radiographic, clinical, and functional outcomes of a consecutive series of patients diagnosed with single or bilateral degenerative disc disease between L4 and S1, that have been treated with an anterior lumbar interbody fusion (ALIF), anterior only surgical approach, and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- One-level or two-level anterior lumbar interbody fusion, InQu Bone Graft Extender and Substitute mixed with BMAC and Synthes Spinal Instrumentation
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2012to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Target population included adult patients from the normal patient population seen at Kansas Joint and Spine Institute, currently also known as Kansas Spine Specialists, that have the ability to provide informed consent without assistance. Each patient that is qualified for an anterior lumbar interbody fusion, with an anterior only approach, will be offered the InQu Bone Graft Extender and Substitute as the bone graft the investigator will use in surgery. Patients that proceed with surgical intervention, and that meet all inclusion/exclusion criteria, will be offered enrollment into the study.
Inclusion Criteria: Patients are eligible for this study if the following criteria are all met.
- Patient will be surgically treated with an anterior lumbar interbody fusion, anterior only approach by one of the listed physician investigators
- Must have had a structural problem potentially amendable to primary fusion at one or two levels
- InQu Bone Graft Extender and Substitute will be used in the surgery
- Had failed conservative care for longer than three (3) months
- Had no psychological contraindications for surgery
- Aged 18 to 70 years of age at the time of surgery
Exclusion Criteria: Patients are ineligible for this study if any one of the following criteria apply.
- Patients that will not be surgically treated with an anterior lumbar interbody fusion, anterior only approach by one of the physician investigators
- InQu Bone Graft Extender and Substitute will not be used in the surgery
- Patient carries any one of the following diagnoses: spinal stenosis requiring decompression, isthmic spondylolisthesis, degenerative spondylolisthesis greater than three (3) millimeters, three or more degenerative levels, major deformity, have had a previous lumbar fusion, or if they have had a previous infection or tumor
- Individuals that can not provide consent for themselves
- Patients requiring revision surgery
- Aged younger than 18 or older than 70 at the time of surgery
- Patients will be excluded from participating in the study if, in the investigators' opinion, they will be unable to comply with study procedures
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 1 recruiting
- Recruiting
Kansas Joint and Spine Institute
Wichita, Kansas, 67226
Jennifer Duong, BA, 316-858-1900 ext. 110, jduong@kjsi.com
Mark C. Whitaker, MD, 316-858-1900, cwhitaker@kjsi.com
- Active, not recruiting
National Center of Innovation for Biomaterials in Orthopaedic Research
Wichita, Kansas, 67226
About this study
Official title: Outcomes of Patients With Lumbar Degenerative Disc Disease Treated Operatively With an Anterior-Only Approach Using InQu Bone Graft Extender and Substitute
The purpose of this study is to report the radiographic, clinical, and functional outcomes of a consecutive series of patients diagnosed with single or bilateral degenerative disc disease between L4 and S1, that have been treated with an anterior lumbar interbody fusion (ALIF), anterior only surgical approach, and InQu Bone Graft Extender and Substitute for bony fusion and instrumentation.
Patients that decide to undergo an Anterior Lumbar Interbody Fusion (ALIF) surgery [a surgical procedure that joins two or more lumbar vertebrae (small bones of the spine) together into one solid bony structure by approaching the spine through the abdomen (front of the body) and placing a bone graft in between the vertebral bodies where the disc usually lies], are invited to participate in an orthopaedic research study.
Read more
This study will compare patients that have been treated with an anterior lumbar interbody fusion using InQu Bone Graft Extender \& Substitute to published data for a stand alone spinal fusion surgery, where InFuse bone graft is placed between the transverse processes [small bony projections off the right and left side of each bone in your spine] of the affected vertebrae.
X-rays, daily activities, and how patients are doing will be evaluated at specific time points during this study.
The hypothesis of this study is that patients diagnosed with degenerative disc disease treated with an anterior lumbar interbody fusion, anterior only surgical approach (incision through the abdomen), using InQu Bone Graft Extender and Substitute and instrumented fixation have comparable radiographic (x-rays), functional (daily activities), and clinical (how the patient is doing) outcomes when compared to published data for use of InFuse in stand-alone fusion.
Read the detailed description
This is a prospective, observational study; evaluating outcomes of patients that have elected to receive surgical intervention in order to treat degenerative disc disease. In order to be eligible for enrollment into this study, patients have already elected to be treated with an anterior lumbar interbody fusion, an anterior only approach for single or bi-level degenerative disc disease between L4 and S1 with instrumented fusion, using a combination of InQu Bone Graft Extender and Substitute, local bone, and Bone Marrow Aspirate Concentrate (BMAC) to promote bony fusion. Only after the patient and physician determine the surgical procedure, can the patient be eligible for enrollment. A consecutive series of 60 patients will be offered enrollment if all inclusion/exclusion criteria are met.
Data will be collected by chart review to include pre-operative, surgical, functional, post-operative, and radiographic imaging charted data, collected as part of the routine clinical visit, and standard of care.
Follow-up data will include newly charted clinical, functional, and radiographic imaging data, including dynamic x-rays and CT scans to be obtained prospectively at a minimum of one (1) year post-operatively. During the routine post-surgical visits, patient pain outcomes are measured using the Visual Analog Scale (VAS) for back and leg pain, function is measured by the Oswestry Disability Index (ODI) and Short Form-12 Version 2 (SF-12 Version 2 Health Survey). A physician investigator will also perform routine clinical evaluations.
The patients will undergo standard radiographic procedures to obtain x-rays (including lateral, anterior-posterior, and dynamic flexion/extension) as part of the standard of care. A CT scan will be performed for research purposes as indicated in the protocol follow-up procedure. X-rays and CT scans will be evaluated by an independent radiologist and a physician investigator to determine anterior fusion status and the status of the anterior hardware constructs.
The National Center of Innovation for Biomaterials in Orthopaedic Research and Medical Metric, Inc. will assist with imaging analysis of x-rays and CTs.
ISTO Technologies, Inc. will be providing a grant to cover costs associated with the research components of this study.
- Conditions
- Degenerative Disc Disease
- Being tested
- One-level or two-level anterior lumbar interbody fusion, InQu Bone Graft Extender and Substitute mixed with BMAC, Synthes Spinal Instrumentation
- Keywords
- Degenerative Disc Disease, InQu Bone Graft Extender and Substitute, Anterior Lumbar Interbody Fusion, Oswestry Disability Index, Visual Analog Scale, Stand-alone ALIF, Bone Marrow Aspirate Concentrate, Fusion rate, Disc Height, Mean Optical Density, Integrated Optical Density
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-level or two-level anterior lumbar interbody fusionProcedure or surgery
Also called ALIF
Patients electing to receive a one-level or two-level, anterior approach only (incision through the front), lumbar interbody fusion in order to treat degenerative disc disease (at one or two levels in the spine), and meeting all other inclusion criteria, are eligible for enrollment into the study.
InQu Bone Graft Extender and Substitute mixed with BMACBiological
Also called InQu, BMAC, SmartPRep2 centrifuge
Surgeries utilizing InQu Bone Graft Extender and Substitute during the anterior lumbar interbody fusion surgical procedure will be elected for inclusion. InQu will be mixed with BMAC (bone marrow aspirate concentrate), which will be prepared using the SmartPRep2 centrifuge. Patients opting to use a grafting alternative will not meet inclusion criteria, and will not be eligible to enroll in this study.
Synthes Spinal InstrumentationDevice
Also called ATB Plate, Peek Cage, SynFix-LR
Synthes Spinal Instrumentation will be used during surgery as spinal stabilization.
| Study group | Role | What they receive |
|---|---|---|
| Degenerative Disc Disease | Patients diagnosed with degenerative disc disease, meeting all eligibility requirements (please refer to inclusion/exclusion criteria), will be asked to participate in this study. A one-level or two-level anterior lumbar interbody fusion surgery using InQu Bone Graft Extender and Substitute, mixed with BMAC (bone marrow aspirate concentrate) as autograft, with Synthes Spinal Instrumentation will be recommended to the patient. If patients elect to proceed with surgery using the prescribed surgical components, they will be offered enrollment into the study. If the patient opts to use a different bone graft, or other spinal instrumentation, then the patient will not meet all inclusion criteria and will not be offered the opportunity to enroll in this study. Receives: Procedure: One-level or two-level anterior lumbar interbody fusion; Biological: InQu Bone Graft Extender and Substitute mixed with BMAC; Device: Synthes Spinal Instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of successful radiographic fusion at 1-year post-operative
X-rays and CTs will be analyzed for fusion based on the following criteria:
- Bridging trabecular bone connecting the two vertebral bodies either through the dowels or around the dowels as evaluated by thin-cut CT scans and radiographs;
- No angular motion of 5 degrees or more on dynamic plain radiographs;
- No sagittal translation of more than 3 mm on dynamic plain radiographs; and
- No radiolucencies that involve more than half of the interfaces between the dowels and the host vertebral end plates.
Criteria is based on the Burkus, Transfelt, et. al study titled "Clinical and Radiographic Outcomes of Anterior Lumbar Interbody Fusion Using Recombinant Human Bone Morphogenetic Protein-2."
Measured: 12-months post-operative
Secondary outcomes (4)
Improvement in Oswestry Disability Index Score (1-year)
Change in ODI and between baseline and 1-year post-operative, anticipating improvement in ODI score (i.e. from baseline to 12-months post-operative, scores should decrease).
Measured: Change from baseline to 12-months post-operative
Improvement in Oswestry Disability Index Scores (2-years)
Change in ODI and between baseline and 2-year post-operative, anticipating improvement in ODI score (i.e. from baseline to 24-months post-operative, scores should decrease).
Measured: Change from baseline to 24-month post-operative
Improvement in Visual Analog Scale Scores (1-year)
Change in VAS and between baseline and 1-year post-operative, anticipating improvement in VAS score (i.e. from baseline to 12-months post-operative, scores should decrease).
Measured: Change from baseline to 12-months post-operative
Improvement in Visual Analog Scale Scores (2-years)
Change in VAS and between baseline and 2-year post-operative, anticipating improvement in VAS score (i.e. from baseline to 24-months post-operative, scores should decrease).
Measured: Change from baseline to 24-months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionMar 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kansas Joint and Spine Institute
- Sponsor type
- Research network
- Collaborators
- National Center of Innovation for Biomaterials in Orthopaedic Research, ISTO Technologies, Inc.
- Responsible party
- Principal investigator, Mark Camden Whitaker, Kansas Joint and Spine Institute
- Investigators
- Mark C Whitaker, MD, Principal investigator, Kansas Joint and Spine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746212
- Sponsor's protocol ID
- InQu ALIF
- Acronym
- InQu
- Status last verified
- Dec 2012
- First submitted
- 3 Dec 2012
- Last updated
- 10 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Patients With Lumbar Degenerative Disc Disease Treated Operatively With an Anterior-Only Approach Using InQu Bone Graft Extender and Substitute
- ClinicalTrials.gov ID
- NCT01746212
- Acronym / sponsor ID
- InQu / InQu ALIF
- Conditions
- Degenerative Disc Disease
- Keywords
- Degenerative Disc Disease, InQu Bone Graft Extender and Substitute, Anterior Lumbar Interbody Fusion, Oswestry Disability Index, Visual Analog Scale, Stand-alone ALIF, Bone Marrow Aspirate Concentrate, Fusion rate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kansas Joint and Spine InstituteResearch network
- Collaborators
- National Center of Innovation for Biomaterials in Orthopaedic Research, ISTO Technologies, Inc.
- Study start
- Dec 2012
- Primary completion
- Mar 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Not posted in the source record
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 is to report the radiographic, clinical, and functional outcomes of a consecutive series of patients diagnosed with single or bilateral degenerative disc disease between L4 and S1, that have been treated with an anterior lumbar interbody fusion (ALIF), anterior only surgical approach, and InQu Bone Graft Extender and Substitute for bony fusion and instrumentation.
Patients that decide to undergo an Anterior Lumbar Interbody Fusion (ALIF) surgery [a surgical procedure that joins two or more lumbar vertebrae (small bones of the spine) together into one solid bony structure by approaching the spine through the abdomen (front of the body) and placing a bone graft in between the vertebral bodies where the disc usually lies], are invited to participate in an orthopaedic research study.
This study will compare patients that have been treated with an anterior lumbar interbody fusion using InQu Bone Graft Extender \& Substitute to published data for a stand alone spinal fusion surgery, where InFuse bone graft is placed between the transverse processes [small bony projections off the right and left side of each bone in your spine] of the affected vertebrae.
X-rays, daily activities, and how patients are doing will be evaluated at specific time points during this study.
The hypothesis of this study is that patients diagnosed with degenerative disc disease treated with an anterior lumbar interbody fusion, anterior only surgical approach (incision through the abdomen), using InQu Bone Graft Extender and Substitute and instrumented fixation have comparable radiographic (x-rays), functional (daily activities), and clinical (how the patient is doing) outcomes when compared to published data for use of InFuse in stand-alone fusion.
Detailed description
This is a prospective, observational study; evaluating outcomes of patients that have elected to receive surgical intervention in order to treat degenerative disc disease. In order to be eligible for enrollment into this study, patients have already elected to be treated with an anterior lumbar interbody fusion, an anterior only approach for single or bi-level degenerative disc disease between L4 and S1 with instrumented fusion, using a combination of InQu Bone Graft Extender and Substitute, local bone, and Bone Marrow Aspirate Concentrate (BMAC) to promote bony fusion. Only after the patient and physician determine the surgical procedure, can the patient be eligible for enrollment. A consecutive series of 60 patients will be offered enrollment if all inclusion/exclusion criteria are met.
Data will be collected by chart review to include pre-operative, surgical, functional, post-operative, and radiographic imaging charted data, collected as part of the routine clinical visit, and standard of care.
Follow-up data will include newly charted clinical, functional, and radiographic imaging data, including dynamic x-rays and CT scans to be obtained prospectively at a minimum of one (1) year post-operatively. During the routine post-surgical visits, patient pain outcomes are measured using the Visual Analog Scale (VAS) for back and leg pain, function is measured by the Oswestry Disability Index (ODI) and Short Form-12 Version 2 (SF-12 Version 2 Health Survey). A physician investigator will also perform routine clinical evaluations.
The patients will undergo standard radiographic procedures to obtain x-rays (including lateral, anterior-posterior, and dynamic flexion/extension) as part of the standard of care. A CT scan will be performed for research purposes as indicated in the protocol follow-up procedure. X-rays and CT scans will be evaluated by an independent radiologist and a physician investigator to determine anterior fusion status and the status of the anterior hardware constructs.
The National Center of Innovation for Biomaterials in Orthopaedic Research and Medical Metric, Inc. will assist with imaging analysis of x-rays and CTs.
ISTO Technologies, Inc. will be providing a grant to cover costs associated with the research components of this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Degenerative Disc Disease | – | Procedure: One-level or two-level anterior lumbar interbody fusion, Biological: InQu Bone Graft Extender and Substitute mixed with BMAC, Device: Synthes Spinal InstrumentationPatients diagnosed with degenerative disc disease, meeting all eligibility requirements (please refer to inclusion/exclusion criteria), will be asked to participate in this study. A one-level or two-level anterior lumbar interbody fusion surgery using InQu Bone Graft Extender and Substitute, mixed with BMAC (bone marrow aspirate concentrate) as autograft, with Synthes Spinal Instrumentation will be recommended to the patient. If patients elect to proceed with surgery using the prescribed surgical components, they will be offered enrollment into the study. If the patient opts to use a different bone graft, or other spinal instrumentation, then the patient will not meet all inclusion criteria and will not be offered the opportunity to enroll in this study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Target population included adult patients from the normal patient population seen at Kansas Joint and Spine Institute, currently also known as Kansas Spine Specialists, that have the ability to provide informed consent without assistance. Each patient that is qualified for an anterior lumbar interbody fusion, with an anterior only approach, will be offered the InQu Bone Graft Extender and Substitute as the bone graft the investigator will use in surgery. Patients that proceed with surgical intervention, and that meet all inclusion/exclusion criteria, will be offered enrollment into the study.
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 |
|---|---|---|
| One-level or two-level anterior lumbar interbody fusionAlso: ALIFPatients electing to receive a one-level or two-level, anterior approach only (incision through the front), lumbar interbody fusion in order to treat degenerative disc disease (at one or two levels in the spine), and meeting all other inclusion criteria, are eligible for enrollment into the study. | Procedure or surgery | Degenerative Disc Disease |
| InQu Bone Graft Extender and Substitute mixed with BMACAlso: InQu, BMAC, SmartPRep2 centrifugeSurgeries utilizing InQu Bone Graft Extender and Substitute during the anterior lumbar interbody fusion surgical procedure will be elected for inclusion. InQu will be mixed with BMAC (bone marrow aspirate concentrate), which will be prepared using the SmartPRep2 centrifuge. Patients opting to use a grafting alternative will not meet inclusion criteria, and will not be eligible to enroll in this study. | Biological | Degenerative Disc Disease |
| Synthes Spinal InstrumentationAlso: ATB Plate, Peek Cage, SynFix-LRSynthes Spinal Instrumentation will be used during surgery as spinal stabilization. | Device | Degenerative Disc Disease |
Primary outcome
Evidence of successful radiographic fusion at 1-year post-operative
Time frame: 12-months post-operative
X-rays and CTs will be analyzed for fusion based on the following criteria: 1. Bridging trabecular bone connecting the two vertebral bodies either through the dowels or around the dowels as evaluated by thin-cut CT scans and radiographs; 2. No angular motion of 5 degrees or more on dynamic plain radiographs; 3. No sagittal translation of more than 3 mm on dynamic plain radiographs; and 4. No radiolucencies that involve more than half of the interfaces between the dowels and the host vertebral end plates. Criteria is based on the Burkus, Transfelt, et. al study titled "Clinical and Radiographic Outcomes of Anterior Lumbar Interbody Fusion Using Recombinant Human Bone Morphogenetic Protein-2."
4 secondary outcomes
Improvement in Oswestry Disability Index Score (1-year)
Time frame: Change from baseline to 12-months post-operative
Improvement in Oswestry Disability Index Scores (2-years)
Time frame: Change from baseline to 24-month post-operative
Improvement in Visual Analog Scale Scores (1-year)
Time frame: Change from baseline to 12-months post-operative
Improvement in Visual Analog Scale Scores (2-years)
Time frame: Change from baseline to 24-months post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2012.
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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.
Mark C Whitaker, MD principal investigator
Kansas Joint and Spine Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease, run by Kansas Joint and Spine Institute at 2 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?
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: status not confirmed, as of the sponsor's last update on 10 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Duong (316-858-1900 ext. 110, jduong@kjsi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of successful radiographic fusion at 1-year post-operative (time frame: 12-months post-operative). 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 10 Dec 2012.