Clinical trial NCT01746212: Outcomes of Degenerative Disc Disease Patients Treated With an Anterior-Only Fusion Using InQu Bone Graft
Official title: Outcomes of Patients With Lumbar Degenerative Disc Disease Treated Operatively With an Anterior-Only Approach Using InQu Bone Graft Extender and Substitute
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Disc Height
Mean Optical Density
Integrated Optical Density
Lead sponsor: Kansas Joint and Spine Institute
Sponsor class: NETWORK
Collaborators: name: National Center of Innovation for Biomaterials in Orthopaedic Research
name: ISTO Technologies, Inc.
First posted: 2012-12-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evidence of successful radiographic fusion at 1-year post-operative
timeFrame: 12-months post-operative
Secondary outcomes:
measure: Improvement in Oswestry Disability Index Score (1-year)
timeFrame: Change from baseline to 12-months post-operative
measure: Improvement in Oswestry Disability Index Scores (2-years)
timeFrame: Change from baseline to 24-month post-operative
measure: Improvement in Visual Analog Scale Scores (1-year)
timeFrame: Change from baseline to 12-months post-operative
measure: Improvement in Visual Analog Scale Scores (2-years)
timeFrame: Change from baseline to 24-months post-operative
Other outcomes:
measure: Surgical Outcomes
timeFrame: At time of surgery
measure: Radiographic Measurements at 6-months post-operative
timeFrame: Change from baseline to 6-months post-operative
measure: Radiographic Measurements at 12-months post-operative
timeFrame: Change from baseline to 12-months post-operative
measure: Radiographic Measurements at 18-months post-operative
timeFrame: Change from baseline to 18-months post-operative
measure: Radiographic Measurements at 24-months post-operative
timeFrame: Change from baseline to 24-months post-operative
Locations:
city: Wichita
country: United States
facility: Kansas Joint and Spine Institute
state: Kansas
city: Wichita
country: United States
facility: National Center of Innovation for Biomaterials in Orthopaedic Research
state: Kansas
Study officials:
affiliation: Kansas Joint and Spine Institute
name: Mark C Whitaker, MD
role: PRINCIPAL_INVESTIGATOR
References: