DDD
Purpose: To design and validate a classification system for degenerative disc disease in the lumbar spine.
Background: Current classification systems for lumbar DDD rely solely on MRI imaging and do not consider the state of degeneration of the facet joints. In order to create a more accurate and effective classification system with specific treatment associations, one must assume the intervertebral joint is a three-joint complex consisting of two posterior facet joints as well as the endplate-disc-endplate joint of the anterior column. The health of the disc as well as the state of the facet joint must be evaluated and classified together.
Proposed Classification System: The proposed classification system presented grades the state of the intervertebral segment in two parts, both the anterior and posterior columns, based on MRI, discography, and plain radiographs. The anterior column is graded on one scale the separates discs with no sagittal or coronal deformities into four categories: A, B, C, and D. Discs showing sagittal deformities are given a grade of E, while discs showing coronal deformities are given a grade of F.
The posterior column is graded on two scales that describe facet degeneration and spinal stenosis. Facet degeneration is graded on a scale of 1-3, with 1 discs showing no facet degeneration, 2 discs showing facet degeneration without stenosis, and 3 discs showing facet degeneration with stenosis. The stenosis scale is used only with 3 discs, and is graded as follows: a discs show central stenosis, b discs show lateral stenosis, and c discs show foraminal stenosis. For complete description of classification system see Papers & Presentations
Research Design: The study population consists of 100 patients between the ages of 18-90 years old who have been positively diagnosed with one or more of the following: DDD, internal disc disruption, spondylolisthesis, or scoliosis. Diagnosis for each patient will include verification by MRI, discography, plain film X-ray, and symptomology as observed by the investigator. All subjects have undergone anterior lumbar interbody fusion with or without posterior fusion & fixation at 1-4 levels from L1-S1. At the time of 6 months follow-up all patients had lateral and anterior/posterior radiographs taken. Data analysis will consist of a review of all images by three spine surgeons in different geographical locations and one spine radiologist. Each specialist will independently grade each operative level according to the classification scale described above. Interobserver and intraobserver reliability and reproducibility will be measured using the kappa statistic.
Potential correlations between DDD classification and according radiographic measures will be studied, as well as whether these variables are independent with respect to classification or whether there are verifiable correlations which hold true.
Project Status: All patients have been seen, operated on, and have completed post operative follow-up. Images are in the final stages of collection and are scheduled to be distributed in the near future to other participating physicians. back to top
Coflex
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Hydraflex
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Discover
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Device Description: The Chaite artificial disc is a prosthetic consisting of two endplates and a sliding core. The unique design is intended to create unconstrained natural motion similar to an intact disc. The device is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (DDD) at one level from L4-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies.
Purpose: To track all current Charite patients.
Summary: Since its premire in the United States in 2004, Dr. Thalgott has
implanted over 40 Charite artificial disc prostheses. In an effort to monitor the progress of our patients with this relatively new device, all patients are asked to complete SF-36, Visual Analog Pain Scores (scale of 1-10) and Oswestry Disability Index forms prior to their surgery and then 3 weeks, 6 weeks, 3 months, six months, and annually after the date of their surgery.
Project Status: Data is currently being collected and stored for up and coming use.
Future Charite Project : In fall of 2006, Dr. Thalgott will begin using the Vector Vision surgical navigation system (BrainLab AG) to implant Charite artificial disc prostheses. Currently the system's orthopaedic spine instrumentation and software package are in their final prototype phases. Dr. Thalgott will work with a team of engineers to perfect the system so it can be made commercially available to other surgeons. back to top
Device Description: The Vertigraft device is a femoral ring allograft from cadaver donors that is cut into the shape of a hollow cylinder to provide strength and load bearing stability to the intervertebral sapace.
Purpose: To compare two different methods of allograft preservation.
Background: One of the most widely used ALIF components in the world, is femoral ring allograft. The femoral ring is allograph, cut in the shape of a hollow cylinder to provide strength and load-bearing stability to the intervertebral space. Allograft is primary processed and stored using two methods, freeze-dried (FD) and frozen (FZ). The major difference between the two methods is that FD material may be stored at room temperature, but must be re-hydrated in saline for 30-60 minutes. FZ allograft must be stored frozen but can be thawed with saline 3-5 minutes prior to use. Although Brantigan et al. used a biomechanical PLIF model to report that FD cancellous allograft fails at an average load of 50% less than the average failure load of FF cancellous allograft, there are no literature examples that compare FZ and FD allograph fusion rates as part of an ALIF procedure. The purpose of the study is to evaluate the efficacy of VertiGraft allograft bone for ALIF as part of a circumferential instrumented fusion, by comparing the clinical and radiographic results between FD and FZ allograft. Further, this study will also explore the effects smoking has on solid fusion, mean time to solid fusion, complications, and clinical outcomes of allograft patients.
Research Design: One VertiGraft device was implanted anteriorly with posterior instrumentation (translaminar screws in 49 patients and pedicle screws in 2 patients) and autogenous posterolateral fusion, at one or two lumbar levels in 25 female and 26 male patients between the ages of 22 and 61 (average 44 years). FD allograph was used in 25 patients (35 levels), and FZ allograft was used in 26 patients (37 levels). Thirteen of the FD allograph patients, and 12 of the FZ allograph patients were smokers. Anteroposterior and lateral radiographs were taken at 3 months post-op. Four-view radiographs, as well as pain and function questionnaires were collected at 6, 12, 18, and 24+ months post-op (up to 54 months).
Project Status: All patients have completed follow-up, data analysis has been completed, and study is currently in its final writing stages.back to top
Device Description:The X STOP is a titanium implant that fits between the spinous processes of the lumbar spine. It
is made from Ti-6A1-4V Eli titanium alloy (ISO 5832/3) and consists of two components: a
spacer assembly and a wing assembly. The spacer assembly is comprised of a tissue expander,
an oval spacer, and a fixed wing. The wing assembly component is comprised of an adjustable
wing and locking screw.
The X STOP isvindicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X STOP is indicated for those patients with moderately impaired physical
function who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or
without back pain, and have undergone a regimen of at least 6 months of nonoperative treatment.The X STOP may be implanted at one or two lumbar levels in patients in whom operative
treatment is indicated at no more than two levels
Purpose: To track the progress of all X-Stop patients.
Summary: In an effort to monitor the progress of our patients with this relatively new device, all patients are asked to complete SF-36, Visual Analog Pain Scores (scale of 1-10) Oswestry Disability Index forms, and Zurich Claudication forms prior to their surgery and then 3 weeks, 6 weeks, 3 months, six months, and annually after the date of their surgery.
Project Status: Approximately 30 patients have recieved an x-stop at our site since January of 2006. Patients are continuing with their follow-up schedules and data is being collected for future analysis. back to top
