An analysis of spine fusion outcomes in sheep pre-clinical models.

PURPOSE: The ovine model is often used to evaluate new spine fusion technologies prior to clinical testing. An important aspect of designing sheep surgery protocols is to select the appropriate postoperative time period for comparing fusion outcomes. Unfortunately, determining the ideal study endpoint is complicated by the fact that prior published studies have not used consistent timeframes. Thus, the primary aim of this study was to provide a reference for investigators as to the expected fusion outcomes of control groups at varying timepoints in sheep spine surgery models. METHODS: We identified published sheep fusion studies using autograft, interbody cages, and/or instrumentation. Fusion data were extracted, converted to a common scale, and analyzed across studied timepoints. RESULTS: Overall, 29 studies of 360 fusion levels were identified: 11 ALIF (158 levels), 3 PLIF/TLIF (28 levels), 8 PLF (90 levels), and 7 ACDF (84 levels). Studied timepoints ranged from 4 to 48 weeks postoperative. In general, fusion rates varied across techniques and instrumentation. The time to reach solid fusion differed by as many as 20 weeks between control groups. CONCLUSIONS: Recommended timeframes for future studies designed to show either superiority over controls or equivalent outcomes with controls were developed based on aggregate results. Designating ideal study endpoints for sheep fusion models has both ethical implications associated with responsible use of animals in research, and economic implications given the cost of animal research. The current results can guide the development of future research methods and help investigators choose appropriate study timelines for various control groups.

A new 3-dimensional method for measuring precision in surgical navigation and methods to optimize navigation accuracy.

PURPOSE: Description of a novel method for evaluation of pedicle screws in 3 dimensions utilizing O-arm(®) and StealthStation(®) navigation; identifying sources of error, and pearls for more precise screw placement. METHODS: O-arm and StealthStation navigation were utilized to place pedicle screws. Initial and final O-arm scans were performed, and the projected pedicle probe track, projected pedicle screw track, and final screw position were saved for evaluation. They were compared to evaluate the precision of the system as well as overall accuracy of final screw placement. RESULTS: Thoracolumbar deformity patients were analyzed, with 153 of 158 screws in adequate position. Only 5 screws were malpositioned, requiring replacement or removal. All 5 were breached laterally and no neurologic or other complications were noted in any of these patients. This resulted in 97 % accuracy using the navigation system, and no neurological injuries or deficits. The average distance of the screw tip and angle of separation for the predicted path versus the final pedicle screw position were analyzed for precision. The mean screw tip distance from the projected tip was 6.43 mm, with a standard deviation of 3.49 mm when utilizing a navigated probe alone and 5.92 mm with a standard deviation of 3.50 mm using a navigated probe and navigated screwdriver (p = 0.23). Mean angle differences were 4.02° and 3.09° respectively (p < 0.01), with standard deviations of 2.63° and 2.12°. CONCLUSIONS: This new technique evaluating precision of screw placement in 3 dimensions improves the ability to define screw placement. Pedicle screw position at final imaging showed the use of StealthStation navigation to be accurate and safe. As this is a preliminary evaluation, we have identified several factors affecting the precision of pedicle screw final position relative to that predicted with navigation.

Long-term Treatment Effects of Lumbar Arthrodeses in Degenerative Disk Disease: A Systematic Review With Meta-Analysis.

STUDY DESIGN: Systematic review with meta-analysis. OBJECTIVE: To (1) evaluate long-term patient-centered clinical outcomes after lumbar arthrodesis with or without decompression for lumbar spondylosis (LS); and (2) compare these outcomes with those of alternative treatments, including nonsurgical and surgical which maintain mobility of the lumbar spine. SUMMARY OF BACKGROUND DATA: The effective treatment of LS is a complex clinical and economic concern for patients and health care providers. SELECTION CRITERIA: (1) randomized controlled clinical trials (RCTs) comparing treatment effects of lumbar arthrodesis with other interventions; (2) participants: skeletally mature adults with lumbar degenerative disk disease. SEARCH METHODS: Ovid MEDLINE, Embase, the Cochrane Library, and others. All years through February of 2013 were included. Patient-centered clinical outcomes before treatment, at 12, 24, or >24 months of follow-up, and rate of complications and additional surgical treatment were collected. A meta-analysis was performed to evaluate pooled treatment effects. The GRADE approach was applied to evaluate the level of evidence. RESULTS: The review included 38 studies of 5738 participants. All studies showed strong or at least moderate treatment effects of lumbar arthrodesis at 12, 24, and 48-72 months of follow-up. The level of evidence was moderate at 12 and 24 months, and low at 48-72 months. The pooled long-term treatment effect of lumbar arthrodesis exceeded those of: nonsurgical treatment (P<0.0001) with a moderate level of evidence, and decompression without fusion (P=0.005) with a low level of evidence. The treatment effect of lumbar arthrodesis showed a small inferiority versus arthroplasty at 12 and 24 months of follow-up (P<0.001), but not after 24 months postoperative. CONCLUSIONS: This review indicates that surgical stabilization of the lumbar spine is an effective treatment for LS; in particular, for patients with severe chronic low back pain that has been resistant to ≥3 months of conservative therapy.

Perioperative and long-term clinical outcomes for bone morphogenetic protein versus iliac crest bone graft for lumbar fusion in degenerative disk disease: systematic review with meta-analysis.

STUDY DESIGN: Systematic review with meta-analysis. OBJECTIVES: To compare the perioperative and long-term postoperative effectiveness of bone morphogenetic protein (BMP) for lumbar arthrodesis in skeletally mature adults with degenerative disk disease (DDD) to that of the current golden standard treatment, iliac crest autologous bone graft (ICBG). SUMMARY OF BACKGROUND DATA: The treatment efficacy of lumbar arthrodesis in DDD is a complex clinical and economic issue for patients and health care providers. METHODS: Comprehensive electronic literature search was performed using following databases: Ovid MEDLINE; Embase; Cochrane Library; Central Register of Controlled Trials (CENTRAL); Database of Abstracts of Reviews of Effects; Methodology Register; Technology Assessment Database; and Economic Evaluation Database. The full year ranges of each database until May of 2012 were included. RESULTS: Eight randomized controlled clinical trials of 383 citations were selected. The included studies involved 1138 participants. The pooled 2-year postoperative clinical outcomes were equivalent in BMP and ICBG groups, and exceeded minimum clinically important differences for Oswestry Disability Index, SF-36 (physical scale), and numeric rating scale (back pain). ICBG was associated with increased pain and complications at the donor site (P<0.01). The pooled average operative time was 21 minutes less in BMP versus ICBG (P<0.001). The pooled rate of additional surgical treatment was 2 times less in the BMP than in the ICBG groups (P=0.006). The pooled risk of nonunion at 24-month follow-up was 2 times less in the BMP than in the ICBG groups (P=0.037), however, this effect was likely biased. CONCLUSIONS: BMP, in particular rhBMP-2, is a good alternative to autogenous bone graft, especially in cases when harvesting of autologous bone is contraindicated or undesirable, operation time is limited, and there are no contraindications for BMP use.However, the current study did not reveal evidence robust enough to develop strong medical recommendations concerning BMP use for lumbar arthrodesis in degenerative disk disease.

Postoperative pelvic incidence (PI) change may impact sagittal spinopelvic alignment (SSA) after instrumented surgical correction of adult spine deformity (ASD).

OBJECTIVES: To study factors causing postoperative change of PI after surgical correction of ASD and to assess the effect of this variability on postoperative PI-LL mismatch. BACKGROUND: PI is used as an individual constant to define lumbar lordosis (LL) correction goal (PI-LL < 10). Postoperative changes of PI were shown but with opposite vectors. The impact of the PI variability on the postoperative PI-LL has not been studied. METHODS: The medical and radiographic data analyzed for patients who underwent long posterior instrumented spinal fusion. Inclusion criteria are age, ≥ 20 years old; ASD due to degenerative disk disease (DDD) or scoliosis (DS); ≥ 3 levels fused; and 2-year follow-up or revision. Studied parameters are LL (L1-S1), PI, sacral slope (SS), pelvic tilt (PT), and PI-LL. Measurement error and postoperative changes were defined. Statistical analysis includes ANOVA, correlation, regression, and risk assessment by odds ratio; P ≤ 0.05 considered statistically significant. RESULTS: Eighty patients were included: mean age, 62.4 years-old (SD, 11.1); female, 63.7%; mean body mass index (BMI), 27.1 (SD, 5.6). Distribution of patients by follow-ups includes preoperative 100%; postoperative (1-3 weeks), 100%; 11-13 months. 90%; 22-26 months, 58%; and revision: 24%. Pre- versus postoperative PI (∆PI) changed both positively and negatively and the absolute value of change|∆PI| exceeded measurement error (P ≤ 0.05) reaching as high as 31°, and progressed with time; R2 dropped from 0.73 to 0.45 (P < 0.001); ∆PI depended on disproportional changes of SS and PT, preoperative PI, and change of LL. Obesity, DS, and absence of sacroiliac fixation increased |∆PI|. The risk of LL insufficient correction (PI-LL > 10°) associated with a |∆PI|> 6°, P = 0.05. Sacroiliac fixation diminished PI variability only during the first postoperative year. CONCLUSION: Preoperative variability and postoperative instability of PI diminish the applicability of the PI-LL < 10° goal to plan correction of LL. An alternative method is offered. LEVEL OF EVIDENCE: IV.

Long-Term Treatment Effect and Predictability of Spinopelvic Alignment After Surgical Correction of Adult Spine Deformity With Patient-Specific Spine Rods.

STUDY DESIGN: Retrospective case series. OBJECTIVE: To evaluate the short- and long-term treatment effect (TE) of spinopelvic parameters after surgical correction of adult spine deformity (ASD) utilizing preoperative planning and patient-specific spine rods (PSSRs), and to assess the correspondence between planned and real outcomes. SUMMARY OF BACKGROUND DATA: PSSR have been used in ASD correction for the last decade. However, a TE and predictability of spinopelvic alignment at long-term follow-up has not been studied. METHODS: Inclusion criteria: male or female; age more than 20 years; correction of ASD with PSSR; 24-month follow-up (or revision surgery). Studied parameters: sagittal vertical axis; lumbar lordosis (LL); pelvic tilt (PT); sacral slope; pelvic incidence (PI); and PI-LL. The measurement error, TE (the differences between postoperative and preoperative values), standardized TE, and predictability of the studied parameters assessed. The variables included categorical (optimal/nonoptimal) and continuous obtained by direct measurements and weighted by individual optimal values. Statistical significance was set at P ≤ 0.05. RESULTS: Thirty-four patients were included: 56% women; the mean age, 63.4 (standard deviation, 12.7); at each follow-up: 32 at 1 to 3 months, 34 at 11 to 13, and 14 at 23 to 25 with 9 followed to the revision surgery. Strong or moderate TE was shown for sagittal vertical axis, LL, and PI-LL. The TE of PT and sacral slope was less significant and lower than planned. PI was not stable in 18%. The changes of continuous variables were more prominent and statistically significant then categorical. The mean values did not show significant differences between planned and postoperative outcomes except for PT. However, the individual deviations were substantial for all parameters. Significant predictability was shown only for LL and PI. CONCLUSION: Use of PSSR showed strong and relatively stable TE in ASD during 2 postoperative years. However, improvement of the planning accuracy may contribute to further enhancement of the method's efficacy. LEVEL OF EVIDENCE: 4.

Validation of Pre-operative Templating for Total Disc Replacement Surgery.

OBJECTIVES: This was an analytic retrospective observational study. The aims were (1) to validate patient-specific templating process by comparing postoperative range of motion (ROM) with that predicted by the model, (2) to retrospectively determine the ideal implant size, height, configuration, and location to evaluate if the ROM achieved could have been improved, and (3) to correlate postoperative ROM and clinical outcome. BACKGROUND: Previous research revealed that after total disc replacement surgery, 34% of patients with less than 5° of postoperative ROM developed adjacent segment disease. The match between patient anatomy (size, facet orientation, disc height) and implant parameters are likely to affect postoperative ROM and clinical outcomes. METHODS: Seventeen consecutive patients were implanted with 22 ProDisc-L devices between 2008 and 2015. Three-dimensional finite element (FE) models of the implanted segment were constructed from preoperative computed tomography scans and virtually implanted with the ProDisc-L implant. ROM was determined with the endpoints of facet impingement in flexion and implant contact in extension. FE templating was used to determine the optimal implant size and location. ROM was then measured directly from flexion and extension radiographs and compared to predicted ROM. Pre and postoperative Oswestry Disability Index (ODI) data were used to correlate ROM with clinical outcomes. RESULTS: No significant difference was found between the actual and predicted ROM. The computational templating procedure identified an optimal ROM that was significantly greater than actual ROM. The ROM in our cohort could have been improved by an average of 1.2° or 12% had a different implant size or position been used. CONCLUSIONS: FE analyses accurately predicted ROM in this cohort and can facilitate selection of the optimal implant size and location that we believe will increase the chance of achieving clinical success with the application of this technology.

Stand-alone Anterior Lumbar Interbody, Transforaminal Lumbar Interbody, and Anterior/Posterior Fusion: Analysis of Fusion Outcomes and Costs.

Fusion outcomes and costs of stand-alone anterior lumbar interbody fusion (ALIF), transforaminal lumbar interbody fusion (TLIF) in association with posterior fusion, and anterior/posterior (A/P) fusion were compared using clinical, radiographic, and billing data. Adult patients with symptomatic 1- or 2-level degenerative disk disease in isolation or in association with a grade 1 or 2 degenerative or lytic spondylolisthesis and canal and/or foraminal stenosis who underwent elective stand-alone ALIF, TLIF, or A/P fusion were compared. The analysis focused primarily on fusion rates and costs and secondarily on radiographic and clinical parameters. One hundred six patients at least 2 years beyond surgery (ALIF, 53; TLIF, 17; A/P fusion, 36) were reviewed. Demographics were similar except for age, with the ALIF group being younger (mean, 37.8 years) than the other groups (TLIF, 53.1 years; A/P fusion, 48.2 years). There were no differences between the groups in fusion rates or outcomes as assessed by the Numeric Rating Scale. Compared with the other 2 groups, the ALIF group had a significantly shorter operative time, less blood loss, and a shorter stay (P<.0001). Evaluation of radiographic parameters revealed significant differences regarding disk angle (P<.001), disk height (P<.0001), and pelvic tilt (P=.001) favoring ALIF and A/P fusion over TLIF. Stand-alone ALIF should be considered in the management of patients with 1- or 2-level lumbar degenerative disk disease for which the pathology can be addressed adequately via this approach. [Orthopedics. 2018; 41(5):e655-e662.].

Spinopelvic Parameters in Asymptomatic Subjects Without Spine Disease and Deformity: A Systematic Review With Meta-Analysis.

STUDY DESIGN: A systematic review with meta-analysis. OBJECTIVE: To combine published data, focusing on the development of optimal spinopelvic parameters in adult asymptomatic subjects without spine deformity while taking into consideration the impact of potential confounders. SUMMARY OF BACKGROUND DATA: A well-grounded approach to define the optimal spinopelvic parameters is necessary for planning surgical correction of spine deformity. MATERIALS: Selection criteria: (1) randomized and nonrandomized prospective, cross-sectional, and retrospective studies; (2) participants: asymptomatic subjects without spine deformity aged above 18 years; (3) studied parameters: lumbar lordosis (LL), pelvic incidence, sacral slope, and pelvic tilt; (4) potential confounders: method of measurement, sex, age, ethnicity, weight, height, and body mass index. Search method: Ovid MEDLINE (1946-current) and EMBASE (1980-current), all years through October 2015 were included. Data were collected: number of enrolled subjects, means of the studied characteristics, SD, SE of the means, 95% confidence intervals. A meta-analysis was performed to evaluate the pooled means and range of optimal values (pooled mean±pooled SD) taking into consideration the impact of confounders. The GRADE approach was applied to evaluate the level of evidence. RESULTS: Seventeen of 1018 studies were included (2926 subjects from 9 countries). The pooled means and the optimal ranges were: LL (L1-S1), 54.6 (42-67) degrees; LL (L1-L5), 37.0 (22-53) degrees; pelvic incidence, 50.6 (39-62) degrees; sacral slope, 37.7 (28-48) degrees; pelvic tilt, 12.6 (3-22) degrees. The pooled results were statistically significant (P<0.001), but heterogeneous. Impact of the following confounders was revealed: method of measurement, ethnicity, age, and body mass index. A methodology was created to define an individualized optimal value and range of each studied parameter taking into consideration the influence of confounders. CONCLUSIONS: The pooled results and developed methodology can be used as diagnostic criteria for evaluation of the spinopelvic parameters, planning of surgical interventions and evaluation of the treatment effect.

Strain in Posterior Instrumentation Resulted by Different Combinations of Posterior and Anterior Devices for Long Spine Fusion Constructs.

STUDY DESIGN: Clinically related experimental study. OBJECTIVE: Evaluation of strain in posterior low lumbar and spinopelvic instrumentation for multilevel fusion resulting from the impact of such mechanical factors as physiologic motion, different combinations of posterior and anterior instrumentation, and different techniques of interbody device implantation. SUMMARY OF BACKGROUND DATA: Currently different combinations of posterior and anterior instrumentation as well as surgical techniques are used for multilevel lumbar fusion. Their impact on risk of device failure has not been well studied. Strain is a well-known predictor of metal fatigue and breakage measurable in experimental conditions. METHODS: Twelve human lumbar spine cadaveric specimens were tested. Following surgical methods of lumbar pedicle screw fixation (L2-S1) with and without spinopelvic fixation by iliac bolt (SFIB) were experimentally modeled: posterior (PLF); transforaminal (TLIF); and a combination of posterior and anterior interbody instrumentation (ALIF+PLF) with and without anterior supplemental fixation by anterior plate or diverging screws through an integrated plate. Strain was defined at the S1 screws, L5-S1 segment of posterior rods, and iliac bolt connectors; measurement was performed during flexion, extension, and axial rotation in physiological range of motion and applied force. RESULTS: The highest strain was observed in the S1 screws and iliac bolt connectors specifically during rotation. The S1 screw strain was lower in ALIF+PLF during sagittal motion but not rotation. Supplemental anterior fixation in ALIF+PLF diminished the S1 strain during extension. Strain in the posterior rods was higher after TLIF and PLF and was increased by SFIB; this strain was lowest after ALIF+PLF, as supplemental anterior fixation diminished the strain during extension, in particular, cages with anterior screws more than anterior plate. Strain in the iliac bolt connectors was mainly determined by direction of motion. CONCLUSIONS: Different devices modify strain in low posterior instrumentation, which is higher after transforaminal and posterior techniques, specifically with spinopelvic fixation. LEVEL OF EVIDENCE: N/A.

What Is the Clinical Relevance of Radiographic Nonunion After Single-Level Lumbar Interbody Arthrodesis in Degenerative Disc Disease?: A Meta-Analysis of the YODA Project Database.

STUDY DESIGN: Meta-analysis of 4 randomized controlled clinical trials (RCTs). OBJECTIVE: The aim of the study was to determine if patients with degenerative disc disease who achieve radiographic fusion after single-level lumbar interbody arthrodesis have better clinical outcomes than patients with radiographic pseudarthrosis at 12 and 24 months postoperative. SUMMARY OF BACKGROUND DATA: The clinical relevance of successful fusion after lumbar arthrodesis with recombinant human bone morphogenetic protein-2 or iliac crest bone autograft has recently been questioned in the literature. METHODS: Individual patient-level data of 4 RCTs were obtained from the Yale University Open Data Access Project project and analyzed. Clinical outcomes (Oswestry Disability Index [ODI]; Numeric Rating Scales [NRSs] for back and leg pain) were compared between patients with radiographically confirmed fusion and those with radiographic nonunion 1 and 2 years postoperative. The results of each study were first analyzed separately, and then were pooled by meta-analysis. The GRADE approach was applied to evaluate the level of evidence. RESULTS: A total of 496 patients with clinical and radiographic data at 1- and 2-year follow-ups were identified. Of these, 5.5% (95% confidence interval: 3.7; 8.3) had radiographic nonunion which did not require reoperation. Patients with fusion had better improvements in ODI (P < 0.001) and NRS back pain scores (P < 0.001). The overall percentage of fused patients with ODI and NRS back pain scores that exceeded the criteria for minimal clinically important differences was also significantly higher than that of patients with nonunion (ODI, odds ratio [OR] = 2.7, P = 0.019; NRS back pain, OR = 3.5, P = 0.033). The predictive values of fusion for clinical outcomes, however, were poor, with low specificity and low negative predictive values. CONCLUSION: The presence of radiographic fusion is clinically significant, as patients with fusion had better clinical outcomes at 1 and 2 years postoperative than those with nonunion; however, patient-centered clinical outcomes should also be taken into consideration as independent, complimentary variables when assessing treatment success.

Sacroiliac Joint Treatment Personalized to Individual Patient Anatomy Using 3-Dimensional Navigation.

During the past 10 years, the sacroiliac (SI) joint has evolved from being barely recognized as a source of pain, to being a joint treated only nonsurgically or with great surgical morbidity, to currently being a joint treated with minimally invasive techniques that are personalized to the individual patient. The complex 3-dimensional anatomy of the SI joint and lack of parallel to traditional imaging planes requires a thorough understanding of the structures within and around the SI joint that may be at risk of injury. Thus, the SI joint is ideally suited for intraoperative 3-dimensional imaging and surgical navigation when being treated minimally invasively.

Patient-Specific Templating of Lumbar Total Disk Replacement to Restore Normal Anatomy and Function.

The purpose of this study was to develop a tool to determine optimal placement and size for total disk replacements (TDRs) to improve patient outcomes of pain and function. The authors developed a statistical shape model to determine the anatomical variables that influence the placement, function, and outcome of lumbar TDR. A patient-specific finite element analysis model has been developed that is now used prospectively to identify patients suitable for TDR and to create a surgical template to facilitate implant placement to optimize range of motion and clinical outcomes. Patient factors and surgical techniques that determine success regarding function and pain are discussed in this article.

Retrograde ejaculation after anterior lumbar spine surgery.

STUDY DESIGN: A retrospective cohort study. OBJECTIVE: To compare the incidence of retrograde ejaculation (RE) after anterior lumbar spine surgery with disc replacement versus fusion with the use of recombinant human bone morphogenetic protein-2 (BMP). SUMMARY OF BACKGROUND DATA: Anterior lumbar interbody fusion (ALIF) has become a popular choice for treating a number of pathologies, largely because it preserves the posterior paravertebral muscles and ligaments. Despite these advantages, the anterior approach is also associated with various complications, one of which is RE. A recent study has questioned whether the risk of RE is increased by the use of BMP in ALIF procedures rather than by the approach alone. METHODS: We conducted a retrospective review of all male patients who received ALIF using BMP or artificial disc replacement (ADR) on at least the L5-S1 level between 2004 and 2011. Medical records were evaluated for the occurrence of RE, and patients were contacted via the phone to obtain current information. The incidence of RE was then compared between the 2 anterior lumbar surgery procedures. RESULTS: Of the 95 cases of anterior surgery including L5-S1, 54 patients underwent ALIF with BMP (56.8%) and 41 patients were treated with ADR (43.2%). Postoperative RE occurred in 4 of the 54 ALIF patients (7.4%) and in 4 of the 41 ADR patients (9.8%). The incidence of RE was not significantly different between groups (P = 0.7226). At latest follow-up, 1 ALIF and 1 ADR patient reported resolution of the RE. CONCLUSION: This study found that RE occurred at a similar rate in patients treated with ADR and ALIF with BMP. The overall rate of RE after retroperitoneal anterior lumbar surgery was higher than expected, which underscores the importance of counseling patients about this risk and specifically questioning patients about the symptoms of RE at postoperative visits.

A new stand-alone anterior lumbar interbody fusion device: biomechanical comparison with established fixation techniques.

STUDY DESIGN: Established lumbar fixation methods were assessed biomechanically, and a comparison was made with a new stand-alone anterior lumbar interbody cage device incorporating integrated anterior fixation. OBJECTIVES: To compare the stability of a new stand-alone anterior implant (Test-device) with established fixation methods to assess its suitability for clinical use. Our hypothesis being that the Test-device would provide stability comparable to that provided by an anterior cage when supplemented with posterior pedicle screw fixation. SUMMARY OF BACKGROUND DATA: It is accepted that the use of rigid pedicle screw instrumentation increases the chance of achieving a solid fusion, but its use may be associated with a significant increase in postoperative morbidity caused by disruption of the posterior musculature. It is also evident that this increased fusion rate is generally not associated with increased clinical success. This dilemma has led to a search for a solution and to the development of the Test-device anterior lumbar interbody device. METHODS: The kinematic properties of either the L3-L4 or L4-L5 lumbar motion segment of 8 cadaveric lumbar spines have been tested using the following sequence of fixation: intact, Test-device, Test-device and translaminar facet screws (TS), Cage and TS, Cage and Universal Spine System (USS), and Cage and small stature USS. RESULTS: All fixation techniques except the cage and TS decreased (P < 0.05) range of motion (ROM), neutral zone (NZ), and elastic zone (EZ), and increased (P < 0.05) stiffness in comparison to the intact motion segment in all test modes. There was a significant increase (P < 0.01) in the ROM, NZ, and EZ, and decrease in the stiffness of the cage and TS group in comparison to all other stabilization techniques in flexion and rotation. There was no significant difference in the ROM, NZ, EZ, and stiffness between the Test-device and cage and USS groups in flexion, extension, and bending. The Test-device resulted in a significantly lower EZ (P < 0.05) and a significantly higher stiffness (P < 0.05) in rotation than all other fixation methods. CONCLUSIONS: The Test-device alone provided similar and the Test-device and TS higher stability than the pedicle screw constructs evaluated. These results support progression to clinical trials using the Test-device as a stand-alone implant.

A randomized, double-blind, controlled trial: intradiscal electrothermal therapy versus placebo for the treatment of chronic discogenic low back pain.

STUDY DESIGN: A prospective, randomized, double-blind, placebo-controlled trial of intradiscal electrothermal therapy (IDET) for the treatment of chronic discogenic low back pain (CDLBP). OBJECTIVES: To test the safety and efficacy of IDET compared with a sham treatment (placebo). SUMMARY OF BACKGROUND DATA: In North America alone, more than 40,000 intradiscal catheters have been used to treat CDLBP. The evidence for efficacy of IDET is weak coming from retrospective and prospective cohort studies providing only Class II and Class III evidence. There is one study published with Class I evidence. This demonstrates statistically significant improvements following IDET; however, the clinical significance of these improvements is questionable. METHODS: Patients with CDLBP who failed to improve following conservative therapy were considered for this study. Inclusion criteria included the presence of one- or two-level symptomatic disc degeneration with posterior or posterolateral anular tears as determined by provocative computed tomography (CT) discography. Patients were excluded if there was greater than 50% loss of disc height or previous spinal surgery. Fifty-seven patients were randomized with a 2:1 ratio: 38 to IDET and 19 to sham procedure (placebo). In all cases, the IDET catheter was positioned to cover at least 75% of the annular tear as defined by the CT discography. An independent technician connected the catheter to the generator and then either delivered electrothermal energy (active group) or did not (sham group). Surgeon, patient, and independent outcome assessor were all blinded to the treatment. All patients followed a standard postprocedural rehabilitation program. Independent statistical analysis was performed. OUTCOME MEASURES: Low Back Outcome Score (LBOS), Oswestry Disability Index (ODI), Short Form 36 questionnaire (SF-36), Zung Depression Index (ZDI), and Modified Somatic Perceptions Questionnaire (MSPQ) were measured at baseline and 6 months. Successful outcome was defined as: no neurologic deficit, improvement in LBOS of greater then 7 points, and improvement in SF-36 subsets (physical function and bodily pain) of greater than 1 standard deviation. RESULTS: Baseline demographic data, initial LBOS, ODI, SF-36, ZDI, and MSPQ were similar for both groups. No neurologic deficits occurred. No subject in either arm showed improvement of greater than 7 points in LBOS or greater than 1 standard deviation in the specified domains of the SF-36. Mean ODI was 41.42 at baseline and 39.77 at 6 months for the IDET group, compared with 40.74 at baseline and 41.58 at 6 months for the placebo group. There was no significant change in ZDI or MSPQ scores for either group. CONCLUSIONS: The IDET procedure appeared safe with no permanent complications. No subject in either arm met criteria for successful outcome. Further detailed analyses showed no significant change in outcome measures in either group at 6 months. This study demonstrates no significant benefit from IDET over placebo.