Clinical Trial: Outcomes of Degenerative Disc Disease Patients Treated With an Anterior-Only Fusion Using InQu Bone Graft

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: Outcomes of Patients With Lumbar Degenerative Disc Disease Treated Operatively With an Anterior-Only Approach Using InQu Bone Graft Extender and Substitute

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

Detailed Summary:

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 pro
Sponsor: Kansas Joint and Spine Institute

Current 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."



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Improvement in Oswestry Disability Index Score (1-year) [ Time Frame: Change from baseline to 12-months post-operative ]
    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).
  • Improvement in Oswestry Disability Index Scores (2-years) [ Time Frame: Change from baseline to 24-month post-operative ]
    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).
  • Improvement in Visual Analog Scale Scores (1-year) [ Time Frame: Change from baseline to 12-months post-operative ]
    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).
  • Improvement in Visual Analog Scale Scores (2-years) [ Time Frame: Change from baseline to 24-months post-operative ]
    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).


Original Secondary Outcome: Same as current

Information By: Kansas Joint and Spine Institute

Dates:
Date Received: December 3, 2012
Date Started: December 2012
Date Completion: May 2015
Last Updated: December 6, 2012
Last Verified: December 2012