A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: part I: evaluation of clinical outcomes.

Study Design: A prospective, randomized, multicenter, Food and Drug Administration-regulated Investigational Device Exemption clinical trial.

Objectives: The purpose of this study was to compare the safety and effectiveness of lumbar total disc replacement, using the CHARITE artificial disc (DePuy Spine, Raynham, MA), with anterior lumbar interbody fusion, for the treatment of single-level degenerative disc disease from L4-S1 unresponsive to nonoperative treatment.

Summary Of Background Data: Reported results of lumbar total disc replacement have been favorable, but studies have been limited to retrospective case series and/or small sample sizes.

Preassembled method for insertion of Ommaya reservoir.

Objective: Present a revised neurosurgical technique for insertion of the Ommaya reservoir that we have routinely utilized and found to have fewer complications that the standard approach.

Experimental Design: Randomized retrospective study of 20 patients who underwent insertion of Ommaya reservoir with the preassembled technique.

Setting: Major university hospital.

Prophylaxis to avert exacerbation/relapse of multiple sclerosis in affected patients undergoing surgery. Surgical observations and recommendations.

To provide the neurological and neurosurgical communities with case evidence of postoperative multiple sclerosis (MS) relapse, literature review to support operative stress-induced relapse and recommendations for perioperative prophylaxis to prevent relapse in patients undergoing surgery. Two case studies are presented with recommendations based on an extensive review of the medical literature and personal experience to support perioperative prophylactic suggestions. Both patients fully recovered to preoperative functional status after treatment.

Lumbar spine arthroplasty using the ProDisc II.

The ProDisc was developed by Thierry Marnay, a French orthopedic surgeon, in the late 1980s. Marnay and his associate implanted ProDiscs into 64 patients from 1990 to 1993. Demonstrating remarkable intellectual restraint, he let this cohort of patients "incubate" so he could see their progress before performing any additional implantations.

Prospective randomized study of the Charite artificial disc: data from two investigational centers.

Background Context: For decades there has been a desire to restore motion of a painful degenerated spinal segment. Artificial discs have been used in Europe for almost 20 years. In the few reports available in the literature, the results have been promising.

Procedural skills in spinal manipulation: do prerequisites matter?

Background Context: Spinal manipulation has undergone a resurgence of interest. Developing evidence suggests a relationship between safety, skill and clinical outcome. Training programs are variable and range from extensive formalized curricula to weekend seminars and individual demonstrations.

Lumbar discography.

Study Design: A comprehensive review of the literature dealing with lumbar discography was conducted.

Objective: The purpose of the review is to update the North American Spine Society position statement published in 1994 that addressed criticisms of lumbar discography, to identify indications for

Summary Of Background Data: Lumbar discography remains a controversial diagnostic procedure. There are concerns about its safety and clinical value, although many support its use in specific applications.

Intervertebral cages for degenerative spinal diseases.

Interbody fusion techniques have been used for many years for the treatment of a variety of lumbar spine diagnoses. Part of the interest in increasing methods of interbody fusion has stemmed from concern that posterior fusion alone may allow micro-motion, which may generate pain in a ruptured or degenerated disc. Stabilization of the anterior segment led to the development of interbody fusion cages.

Biomechanics of spinal manipulative therapy.

Background Context: Modern scientific investigations into spinal manipulative therapy (SMT) began in 1975. Conditions often treated include acute and chronic low back pain, radicular pain, neck pain, and some forms of headache. The field of spinal manipulation has often been treated by the literature, incorrectly, as being homogeneous.

Patient satisfaction with spinal cord stimulation for predominant complaints of chronic, intractable low back pain.

Background Context: Results of subsequent surgical intervention in patients with intractable pain after lumbar spine surgery are typically worse than for initial surgery, particularly in those with predominant complaints of back pain rather than lower extremity pain. Spinal cord stimulation (SCS) has been found to yield good results in patients with primary complaints of intractable lower extremity pain. Technological advances have broadened the indications for this treatment.

Clinical results with ProDisc: European experience and U.S. investigation device exemption study.

Study Design: This study is based on a review of the literature related to the use of the ProDisc device and a report of the preliminary results of a prospective randomized study.

Objectives: To review European results related to the use of the ProDisc device and compare the results of this device to lumbar fusion in a prospective, randomized study being performed as part of a Food and Drug Administration-approved investigational study.

Summary Of Background Data: There are two devices that have been used on a large-scale basis for total disc replacement.

Prospective study evaluating total disc replacement: preliminary results.

For many years, there has been an interest in disc replacements. There are a few retrospective studies from Europe reporting promising results for these devices. The purpose of this study is to review the preliminary results of the SB Charité disc replacement device in a prospective study.

Case report: intraoperative left common iliac occlusion in a scheduled 360-degree spinal fusion.

Study Design: This is a case report of a left common iliac artery occlusion identified as an intraoperative complication during a planned (combined anterior interbody and posterior fusion) 360 degrees spinal fusion.

Objective: The purpose of this report was to document the occurrence of this rare complication during a planned 360 degrees fusion and to increase the awareness of this potential intraoperative vascular complication.

Summary Of Background Data: Several cases of left iliac artery occlusion after anterior spinal surgery have been reported, but there has been no reported case of intraoperative iliac artery occlusion identified during a planned 360 degrees spinal fusion.

Lumbar spine arthroplasty: early results using the ProDisc II: a prospective randomized trial of arthroplasty versus fusion.

This study represents the first 39 patients with at least 6-month follow-up enrolled in a prospective randomized Food and Drug Administration study evaluating the safety and efficacy of the ProDisc II versus the control, a 360 degrees lumbar spinal fusion. Data were collected preoperatively and at 6 weeks, 3 months, and 6 months postoperatively. Visual Analog Scale (VAS), Oswestry Low Back Pain Disability Questionnaire (ODQ), and patient satisfaction rates were evaluated at these intervals, as well as range of motion, return to work, and recreational and ambulatory status.

Intervertebral disc prostheses.

Study Design: This article is based on a comprehensive review of the literature related to intervertebral disc prostheses.

Objective: To compile an overview of the results and complications related to various types of lumbar and cervical disc replacements.

Summary Of Background Data: A functional disc prosthesis has been sought since the 1950s.

Quantitative feedback versus standard training for cervical and thoracic manipulation.

Objective: To quantify elements of spinal manipulation therapy performance and to test the strategy of combined rehearsal and quantitative feedback as a means of enhancing student skill development for cervical and thoracic manipulative procedures.

Design: Randomized, controlled study.

Setting: Chiropractic college.

Artificial disc: preliminary results of a prospective study in the United States.

Artificial discs have been used in Europe for many years with good results. This technology has recently been available in the United States on a limited, investigational basis. The purpose of this study is to review the preliminary results of one center's experience using the SB Charité III disc replacement.

Developing skilled performance of lumbar spine manipulation.

Objective: To quantify elements of spinal manipulation therapy performance and to test the strategy of combined rehearsal and quantitative feedback as a means of enhancing student skill development.

Design: Randomized, controlled study.

Setting: Chiropractic college.

The relationship of disability (Oswestry) and pain drawings to functional testing.

Unlabelled: There was much enthusiasm about the development of computerized dynamometry in providing large quantities of data to objectively assess muscle performance. However, a much more basic issue arose questioning what these machines actual measure, particularly in pain populations. The purpose of the present study was to determine whether patients' self-reported disability and pain expression, as evaluated with simple questionnaires, were related to isokinetic performance in low back pain patients.

Repeatability of pain drawings in a low back pain population.

Study Design: This is a prospective test-retest repeatability study.

Objective: The primary purpose of this study was to determine the test-retest repeatability, using a variety of scoring methods, of pain drawings in a group of chronic low back pain patients. The intraevaluator repeatability for the methods requiring subjective interpretation was also evaluated.

Laparoscopic approach to L4-L5 for interbody fusion using BAK cages: experience in the first 58 cases.

Study Design: Operative reports were reviewed for patients who underwent laparoscopic fusion at the L4-L5 level and information regarding the mobilization of the vessels was recorded.

Objective: The purpose of this study was to describe variations in the approach used to address anatomical variations in the location of the great vessel bifurcation in the region of the L4-L5 intervertebral disc space when performing laparoscopic interbody fusion procedures.

Summary Of Background Data: Recent interest in laparoscopic spine surgery using threaded cages has resulted in questions regarding the ability to safely access the L4-L5 disc using this approach.