Outcomes of Degenerative Disc Disease Patients Treated With an Anterior-Only Fusion Using InQu Bone Graft
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/2/2016 |
| Start Date: | December 2012 |
| End Date: | May 2015 |
| Contact: | Jennifer Duong |
| Email: | jduong@kjsi.com |
| Phone: | 316-858-1900 |
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.
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.
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.
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.
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.
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
We found this trial at
2
sites
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