The fate of prospective spine studies registered on www.ClinicalTrials.gov.

Background Context: There has been concern expressed about research ethics with respect to not fully reporting data collected during clinical studies. One site available for all clinical trials is ClinicalTrials.gov.

Prospective, Randomized Comparison of Cervical Total Disk Replacement Versus Anterior Cervical Fusion: Results at 48 Months Follow-up.

Study Design: This was a prospective, randomized, controlled multicenter trial.

Objective: The purpose of this study was to compare clinical outcomes at 4-year follow-up of patients receiving cervical total disk replacement (TDR) with those receiving anterior cervical discectomy and fusion (ACDF).

Summary Of Background Data: ACDF has been the traditional treatment for symptomatic disk degeneration.

Comparison of 2 lumbar total disc replacements: results of a prospective, randomized, controlled, multicenter Food and Drug Administration trial with 24-month follow-up.

Study Design: This was a prospective, randomized, controlled multicenter study with 24-month follow-up.

Objective: The purpose of this study was to evaluate the safety and efficacy in a Food and Drug Administration Investigation Device Exemption of a new lumbar total disc replacement (TDR) by comparing it to an earlier TDR approved for sale.

Summary Of Background Data: Randomized trials have reported TDR to produce results similar or superior to lumbar fusion.

L5 radiculopathy caused by L5 nerve root entrapment by an L5-S1 anterior osteophyte.

Background: L5 radiculopathy is a common problem that has several causes. Entrapment of the L5 nerve root by anterior osteophytes at the L5-S1 junction is rarely reported. Posterior decompression of the L5 nerve root is commonly performed, but anterior decompression of the L5 nerve root is not a frequently performed procedure.

Analysis of adjacent segment reoperation after lumbar total disc replacement.

Background: Fusion has long been used for treating chronic back pain unresponsive to nonoperative care. However, potential development of adjacent segment degeneration resulting in reoperation is a concern. Total disc replacement (TDR) has been proposed as a method for addressing back pain and preventing or reducing adjacent segment degeneration.

Minimally invasive trans-sacral approach to L5-S1 interbody fusion: Preliminary results from 1 center and review of the literature.

Background: Lumbar interbody fusion has long been used for the treatment of painful degenerative spinal conditions. The anterior approach is not feasible in some patients, and the posterior approach is associated with a risk of neural complications and possibly muscle injury. A trans-sacral technique was developed that allows access to the L5-S1 disc space.

Cervical total disc replacement using a novel compressible prosthesis: Results from a prospective Food and Drug Administration-regulated feasibility study with 24-month follow-up.

Background: Anterior cervical fusion, an established procedure to treat cervical radiculopathy, sacrifices the natural function of the disc, while placing increased stresses on adjacent spinal levels. In contrast, the cervical total disc replacement (cTDR) maintains motion and decreases adjacent-level stresses. The purpose of this study was to investigate the safety and effectiveness of a next-generation cTDR device in patients with symptomatic cervical radiculopathy.

Effect of adverse events on low back surgery outcome: twenty-four-month follow-up results from a Food And Drug Administration investigational device exemptiontrial.

Study Design: This study was based on a post hoc analysis of data collected from a prospective FDA-regulated trial comparing total disc replacement to fusion surgery.

Objective: he purpose of this study was to determine if the occurrence of adverse events (AEs) had an impact on outcomes of low back surgery.

Summary Of Background Data: AEs are rigorously recorded during clinical trials primarily to evaluate the safety of the investigational device.

Avascular necrosis of lumbar facet joints associated with bilateral facet fractures.

Background Context: Avascular necrosis is a commonly described condition caused by a disruption of blood supply to the bones, resulting in necrosis. Although common in joints of the extremities, it is seen less often in the spine. Risk factors for avascular necrosis include steroid use, alcohol consumption, smoking, scuba diving, thrombosis, hypercoagulability, and hypertension.

Twenty-four month follow-up for reporting results of spinal implant studies: Is this guideline supported by the literature?

Background: Traditionally, spine societies and journals have set guidelines requiring a minimum 24-month follow-up for reporting results of surgical implant studies. However, the basis for this particular time period is not clear. The purpose of this study was to analyze prospective spinal implant studies reporting data at multiple specific follow-up periods to determine if there were significant changes in the clinical outcome throughout the 24-month follow-up period.

Lumbar spinal arthroplasty: analysis of one center's twenty best and twenty worst clinical outcomes.

Study Design: This is a retrospective analysis of data that were collected prospectively from 2 concurrent FDA IDE lumbar arthroplasty clinical trials performed at a single center.

Objectives: The purpose of this study was to determine if factors differentiating those patients with the best and worst clinical outcomes from total disc arthroplasty (TDR) could be identified.

Summary Of Background Data: Overall the results of TDR have been favorable, including recent results from 2 FDA IDE trials conducted in the United States.

Relationship between the length of time off work preoperatively and clinical outcome at 24-month follow-up in patients undergoing total disc replacement or fusion.

Background Context: A recent study involving interbody fusion patients found that preoperative work status was significantly related to clinical outcome. In another study comparing the best and worst outcomes of total disc replacement, among a battery of variables analyzed, the only one that differentiated the best and worst outcome groups was the length of time off work before total disc replacement.

Purpose: The purpose of this study was to determine if there was a relationship between the length of time off work and treatment outcome at 24-month follow-up.

Comparison of results of total disc replacement in postdiscectomy patients versus patients with no previous lumbar surgery.

Study Design: Data for this study were collected as part of a prospective Food and Drug Administration regulated IDE trial for the ProDisc total disc replacement.

Objective: The purpose of the study was to compare the results of total disc replacement (TDR) in patients with previous discectomy to patients who had no such previous surgery.

Summary Of Background Data: Discectomy is a well accepted surgical procedure for appropriately selected patients.

Comparison of 2-Level Versus 1-Level Total Disc Replacement: Results From a Prospective FDA-Regulated Trial.

Background: Fusion has been the traditional surgery for painful disc degeneration unresponsive to nonoperative care. Fusion rates may decline in multilevel procedures. Also, fusion may force additional stress onto adjacent discs.

Two- to 3-Year Follow-Up of ProDisc-L: Results From a Prospective Randomized Trial of Arthroplasty Versus Fusion.

Background: Although total disc replacement has been performed for years outside the United States, relatively little available data address clinical outcomes, particularly data from prospective studies. We report the 24- to 36-month follow-up of one center's experience with the ProDisc-L artificial disc as part of a prospective, randomized trial comparing total disc arthroplasty to combined anterior-posterior lumbar fusion.

Methods: The study involved clinical results for 157 patients from a single center enrolled in the US Food and Drug Administration-regulated trial comparing ProDisc-L to fusion.

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.

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.

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.

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.

Relation between pain location and disc pathology: a study of pain drawings and CT/discography.

Objective: The purpose of this study was to determine whether pain location indicated in pain drawings was related to the specific lumbar disc level(s) that was abnormal in appearance and painful upon discographic injection.

Design: Data were collected prospectively.

Setting: This study was conducted in a spine specialty clinic.

Relationship of pain drawings to invasive tests assessing intervertebral disc pathology.

It has been found that the pain patterns in pain drawings are related to the presence of herniated disc identified by myelography. The purpose of this study was to determine whether the pattern of pain in the drawings or the type of pain indicated (aching, burning, numbness, pins and needles, stabbing) was related to the presence of symptomatic disc pathology identified by CT/discography. In a subgroup of patients who underwent myelography, the relationship of the drawings to myelographic findings was also investigated.

Vibration pain provocation can improve the specificity of MRI in the diagnosis of symptomatic lumbar disc rupture.

Objective: The purpose of this study was to determine if vibration pain provocation could be combined with magnetic resonance imaging (MRI) to increase its specificity in identifying symptomatic disc disruption identified by discography.

Design: Prospective single-blind study.

Setting: Data were collected at a spine specialty clinic and at a diagnostic imaging center.