Lumbar Discectomy With Bone-Anchored Annular Closure Device in Patients With Large Annular Defects: One-Year Results.

BACKGROUND: Reherniation rates following lumbar discectomy are low for most patients; however, patients with a large defect in the annulus fibrosis have a significantly higher risk of recurrence. Previous results from a randomized controlled trial (RCT) demonstrated that the implantation of a bone-anchored annular closure device (ACD) during discectomy surgery lowered the risk of symptomatic reherniation and reoperation over one year with fewer serious adverse events (SAEs) compared to discectomy alone. OBJECTIVE: The objective of this prospective, post-market, historically controlled study was to evaluate the use of an ACD during discectomy, and to confirm the results of the RCT that was used to establish regulatory approval in the United States. METHODS: In this post-market study, all patients (N = 55) received discectomy surgery with a bone-anchored ACD. The comparison population was patients enrolled in the RCT study who had discectomy with an ACD (N = 262) or discectomy alone (N = 272). All other eligibility criteria, surgical technique, device characteristics, and follow-up methodology were comparable between studies. Endpoints included rate of symptomatic reherniation or reoperation, SAEs, and patient-reported measures of disability, pain, and quality of life. RESULTS: Fifty-five patients received ACD implants at 12 sites between May 2020 and February 2021. In the previous RCT, 272 control patients had discectomy surgery alone (RCT-Control), and 262 patients had discectomy surgery with an ACD implant (RCT-ACD). Baseline characteristics across groups were typical of the overall population undergoing lumbar discectomy. The proportion of patients who experienced reherniation and/or reoperation was significantly lower in the ACD group compared to RCT-ACD and RCT-Control groups (p < 0.05). In the ACD study, the one-year rate of symptomatic reherniation was 3.7%, compared to 8.5% in the RCT-ACD group and 17.0% in the RCT-Control group. In the ACD group, the risk of reoperation was 5.5%, compared to 6.5% in the RCT-ACD group and 12.5% in the RCT-Control group. There were no device-related SAEs or device integrity failures in the ACD, and there were clinically meaningful improvements in patient-reported measures of disability, pain, and quality of life. CONCLUSION: In this post-market study of bone-anchored ACD in patients with large annular defects, rates of symptomatic reherniation, reoperation, and SAEs were all low. Compared to the RCT, the post-market ACD study demonstrated lower rates of reherniation and/or reoperation and measures of back pain one-year post-surgery.

Does the ACS NSQIP Surgical Risk Calculator Accurately Predict Complications Rates After Anterior Lumbar Interbody Fusion Procedures?

STUDY DESIGN: Clinical case series. OBJECTIVE: The aim of this study was to determine the effectiveness of the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) surgical risk calculator in the prediction of complications after anterior lumbar interbody fusion (ALIF). SUMMARY OF BACKGROUND DATA: Identifying at-risk patients may aid in the prevention of complications after spine procedures. The ACS NSQIP surgical risk calculator was developed to predict 30-day postoperative complications for a variety of operative procedures. METHODS: Medical records of patients undergoing ALIF at our institution from 2009 to 2019 were retrospectively reviewed. Demographic and comorbidity variables were entered into the ACS NSQIP surgical risk calculator to generate percentage predictions for complication incidence within 30 days postoperatively. The observed incidences of these complications were also abstracted from the medical record. The predictive ability of the ACS NSQIP surgical risk calculator was assessed in comparison to the observed incidence of complications using area under the curve (AUC) analyses. RESULTS: Two hundred fifty-three (253) patients were analyzed. The ACS NSQIP surgical risk calculator was a fair predictor of discharge to non-home facility (AUC 0.71) and surgical site infection (AUC 0.70). The ACS NSQIP surgical risk calculator was a good predictor of acute kidney injury/progressive renal insufficiency (AUC 0.81). The ACS NSQIP surgical risk calculator was not an adequate predictive tool for any other category, including: pneumonia, urinary tract infections, venous thromboembolism, readmission, reoperations, and aggregate complications (AUC < 0.70). CONCLUSION: The ACS NSQIP surgical risk calculator is an adequate predictive tool for a subset of complications after ALIF including acute kidney injury/progressive renal insufficiency, surgical site infections, and discharge to non-home facilities. However, it is a poor predictor for all other complication groups. The reliability of the ACS NSQIP surgical risk calculator is limited, and further identification of models for risk stratification is necessary for patients undergoing ALIF.Level of Evidence: 3.

Lumbar Discectomy With Barricaid Device Implantation in Patients at High Risk of Reherniation: Initial Results From a Postmarket Study.

Background Patients with large defects in the annulus fibrosus following lumbar discectomy have high rates of symptomatic reherniation and reoperation. An FDA randomized controlled trial (RCT) with a bone-anchored device (Barricaid, Intrinsic Therapeutics, Woburn, MA) that occludes the annular defect reported significantly lower risk of symptomatic reherniation and reoperation compared to patients receiving discectomy only. However, results of the Barricaid device in real-world use remain limited.  Methods This was a post-market study to determine the real-world outcomes of the Barricaid device when used in addition to primary lumbar discectomy in patients with large annular defects. Main outcomes included leg pain severity, Oswestry Disability Index (ODI), adverse events, symptomatic reherniation, and reoperation. Imaging studies were read by an independent imaging core laboratory. This paper reports the initial three-month primary endpoint results from the trial; one-year patient follow-up is ongoing. Results Among 55 patients (mean age 41±13 years, 60% male), the mean percent reduction in leg pain severity was 92%, and the mean percent reduction in ODI score was 79%. The three-month rate of symptomatic reherniation was 3.6% and the rate of reoperation was 1.8%. The serious adverse event rate was 5.5%; no device migrations or fractures were observed.  Conclusion Among patients with large annular defects following lumbar discectomy treated with the Barricaid device in real-world conditions, early results demonstrated clinically meaningful improvements in patient symptoms and low rates of symptomatic reherniation, reoperation, and complications, which were comparable to those observed with the device in an FDA-regulated trial.

Multicenter study of lumbar discectomy with Barricaid annular closure device for prevention of lumbar disc reherniation in US patients: A historically controlled post-market study protocol.

BACKGROUND: Patients with large defects in the annulus fibrosus following lumbar discectomy have high rates of symptomatic reherniation. The Barricaid annular closure device provides durable occlusion of the annular defect and has been shown to significantly lower the risk of symptomatic reherniation in a large European randomized trial. However, the performance of the Barricaid device in a United States (US) population has not been previously reported. DESIGN AND METHODS: This is a historically controlled post-market multicenter study to determine the safety and efficacy of the Barricaid device when used in addition to primary lumbar discectomy in a US population. A total of 75 patients with large annular defects will receive the Barricaid device following lumbar discectomy at up to 25 sites in the US and will return for clinical and imaging follow-up at 4 weeks, 3 months, and 1 year. Trial oversight will be provided by a data safety monitoring board and imaging studies will be read by an independent imaging core laboratory. Patients treated with the Barricaid device in a previous European randomized trial with comparable eligibility criteria, surgical procedures, and outcome measures will serve as historical controls. Main outcomes will include back pain severity, leg pain severity, Oswestry Disability Index, health utility on the EuroQol-5 Dimension questionnaire, complications, symptomatic reherniation, and reoperation. Propensity score adjustment using inverse probability of treatment weighting will be used to adjust for differences in baseline patient characteristics between the US trial participants and European historical controls. ETHICS AND DISSEMINATION: This study was approved by a central institutional review board. The study results of this trial will be widely disseminated at conference proceedings and published in peer-reviewed journals. The outcomes of this study will have important clinical and economic implications for all stakeholders involved in treating patients with lumbar discectomy in the US. STUDY REGISTRATION: ClinicalTrials.gov (https://clinicaltrials.gov): NCT03986580. LEVEL OF EVIDENCE: 3.

A comparison of the Wiltse versus midline approaches in degenerative conditions of the lumbar spine.

OBJECTIVE The objective of this study was to determine if there is a significant difference in surgical site infection (SSI) when comparing the Wiltse and midline approaches for posterior instrumented interbody fusions of the lumbar spine and, secondarily, to evaluate if the reoperation rates and specific causes for reoperation were similar for both approaches. METHODS A total of 358 patients who underwent 1- or 2-level posterior instrumented interbody fusions for degenerative lumbar spinal pathology through either a midline or Wiltse approach were prospectively followed between March 2005 and January 2011 at a single tertiary care facility. A retrospective analysis was performed primarily to evaluate the incidence of SSI and the incidence and causes for reoperation. Secondary outcome measures included intraoperative complications, blood loss, and length of stay. A matched analysis was performed using the Fisher's exact test and a logistic regression model. The matched analysis controlled for age, sex, comorbidities, number of index levels addressed surgically, number of levels fused, and the use of bone grafting. RESULTS All patients returned for follow-up at 1 year, and adverse events were followed for 2 years. The rate of SSI was greater in the midline group (8 of 103 patients; 7.8%) versus the Wiltse group (1 of 103 patients; 1.0%) (p = 0.018). Fewer additional surgical procedures were performed in the Wiltse group (p = 0.025; OR 0.47; 95% CI 0.23-0.95). Proximal adjacent segment failure requiring reoperation occurred more frequently in the midline group (15 of 103 patients; 14.6%) versus the Wiltse group (6 of 103 patients; 5.8%) (p = 0.048). Blood loss was significantly lower in the Wiltse group (436 ml) versus the midline group (703 ml); however, there was no significant difference between the 2 groups in intraoperative complications or length of stay. CONCLUSIONS The patients who underwent the Wiltse approach had a decreased risk of wound breakdown and infection, less blood loss, and fewer reoperations than the midline patients. The risk of adjacent segment failure in short posterior constructs is lower with a Wiltse approach.

Incidence and risk of delayed surgical site infection following instrumented lumbar spine fusion.

We reviewed a retrospective case series of patients with delayed infections after spinal fusion, and surveyed medical experts in Canada and the USA regarding their use of prophylactic antibiotics for patients undergoing invasive procedures following spine surgery. Infections after spinal fusion are a relatively common complication, which typically occur early in the postoperative period. Infections which occur more than 3months from the index procedure are rare and are often caused by atypical pathogens. The proportion of infections that required debridement and occurred 6 months after the index procedure was 4.3% (7/162). Over 85% of these infections were polymicrobial, with one third of those containing methicillin-resistant Staphylococcus aureus. The most common operative indications were either trauma or tumour, and most patients with a delayed infection had a distant chronic infection. The majority of spine experts do not routinely recommend prophylactic antibiotics for invasive procedures after spine fusion. In the multivariate analysis, experts were more likely to recommend antibiotics for patients undergoing a non-dental procedure, those who were diabetic, and those who were greater than 1year out from their procedure. In summary, the delayed presentation of infection after instrumented spinal fusion is a rare but serious complication. However, due to its infrequency, routine prophylaxis to prevent haematogenous seeding is likely unnecessary.

Controlled Laboratory Comparison Study of Motion With Football Equipment in a Destabilized Cervical Spine: Three Spine-Board Transfer Techniques.

BACKGROUND: Numerous studies have shown that there are better alternatives to log rolling patients with unstable spinal injuries, although this method is still commonly used for placing patients onto a spine board. No previous studies have examined transfer maneuvers involving an injured football player with equipment in place onto a spine board. PURPOSE: To test 3 different transfer maneuvers of an injured football player onto a spine board to determine which method most effectively minimizes spinal motion in an injured cervical spine model. STUDY DESIGN: Controlled laboratory study. METHODS: Five whole, lightly embalmed cadavers were fitted with shoulder pads and helmets and tested both before and after global instability was surgically created at C5-C6. An electromagnetic motion analysis device was used to assess the amount of angular and linear motion with sensors placed above and below the injured segment during transfer. Spine-boarding techniques evaluated were the log roll, the lift and slide, and the 8-person lift. RESULTS: The 8-person lift technique resulted in the least amount of angular and linear motion for all planes tested as compared with the lift-and-slide and log-roll techniques. This reached statistical significance for lateral bending (P = .031) and medial-lateral translation (P = .030) when compared with the log-roll maneuver. The lift-and-slide technique was significantly more effective at reducing motion than the log roll for axial rotation (P = .029) and lateral bending (P = .006). CONCLUSION: The log roll resulted in the most motion at an unstable cervical injury as compared with the other 2 spine-boarding techniques examined. The 8-person lift and lift-and-slide techniques may both be more effective than the log roll at reducing unwanted cervical spine motion when spine boarding an injured football player. Reduction of such motion is critical in the prevention of iatrogenic injury.

Surgeon-industry conflict of interest: survey of North Americans' opinions regarding surgeons consulting with industry.

BACKGROUND CONTEXT: Surgeon-industry conflict of interest (COI) has become a source of considerable interest. Professional medical societies, industry, and policy makers have attempted to regulate potential COI without consideration for public opinion. PURPOSE: The objective of this study was to report on the opinions of individuals representing the general public regarding surgeon-industry consulting relationships. STUDY DESIGN/SETTING: Web-based survey. METHODS: Survey was administered using a "spine Web site," and opinions are collected on surgeon-industry consulting and regulation. Associations among responses to similar questions were assessed to ensure validity and subgroup analysis performed for respondent age, sex, education, insurance, employment, and patient status. RESULTS: Six hundred ten of 642 surveys had complete data. The sample population comprised more females and was older and more educated than the American population. About 80% of respondents felt it was ethical and either beneficial or of no influence to the quality of health care if surgeons were consultants for surgical device companies. Most felt disclosure of an industry relationship was important and paying surgeons royalties for devices, other than those they directly implant, would not affect quality of care. Respondents support multidisciplinary surgeon-industry COI regulation and trust doctors and their professional societies to head this effort. CONCLUSIONS: Despite the known potential negative impact of surgeon-industry COI on patient care, this study revealed that this does not seem to be reflected in the opinion of the general public. The respondents felt that disclosure is deemed one of the most important means of self-regulation and COI management, which is in agreement with current trends of most spine societies and journals that are increasing the stringency of disclosure policies.

Surgeon-industry conflict of interest: survey of opinions regarding industry-sponsored educational events and surgeon teaching: clinical article.

OBJECT: Conflict of interest (COI) as it applies to medical education and training has become a source of considerable interest, debate, and regulation in the last decade. Companies often pay surgeons as faculty for educational events and often sponsor and give financial support to major professional society meetings. Professional medical societies, industry, and legislators have attempted to regulate potential COI without consideration for public opinion. The practice of evidence-based medicine requires the inclusion of patient opinion along with best available evidence and expert opinion. The primary goal of this study was to assess the opinion of the general population regarding surgeon-industry COI for education-related events. METHODS: A Web-based survey was administered, with special emphasis on the surgeon's role in industry-sponsored education and support of professional societies. A survey was constructed to sample opinions on reimbursement, disclosure, and funding sources for educational events. RESULTS: There were 501 completed surveys available for analysis. More than 90% of respondents believed that industry funding for surgeons' tuition and travel for either industry-sponsored or professional society educational meetings would either not affect the quality of care delivered or would cause it to improve. Similar results were generated for opinions on surgeons being paid by industry to teach other surgeons. Moreover, the majority of respondents believed it was ethical or had no opinion if surgeons had such a relationship with industry. Respondents were also generally in favor of educational conferences for surgeons regardless of funding source. Disclosures of a surgeon-industry relationship, especially if it involves specific devices that may be used in their surgery, appears to be important to respondents. CONCLUSIONS: The vast majority of respondents in this study do not believe that the quality of their care will be diminished due to industry funding of educational events, for surgeon tuition, and/or travel expenses. The results of this study should help form the basis of policy and continued efforts at surgeon-industry COI management.

Motion is reduced in the unstable spine with the use of mechanical devices for bed transfers.

CONTEXT: Excessive spinal motion generated during multiple bed transfers of patients with unstable spine injuries may contribute to neurological deterioration. OBJECTIVE: To evaluate spinal motion in a cadaveric model of global spinal instability during hospital bed transfers using several commonly used techniques. DESIGN/PARTICIPANTS: A motion analysis and evaluation of hospital bed transfer techniques in a cadaveric model of C5-C6 and T12-L2 global spinal instability. Setting/outcome measures: Global instability at C5-C6 and T12-L2 was created. The motion in three planes was measured in both the cervical and lumbar spine during each bed transfer via electromagnetic motion detection devices. Comparisons between transfers performed using an air-assisted lateral transfer device, manual transfer, a rolling board, and a sliding board were made based on the maximum range of motion observed. RESULTS: Significantly less lateral bending at C5-C6 was observed in air-assisted device transfers when compared with the two other boards. Air-assisted device transfers produced significantly less axial rotation at T12-L2 than the rolling board, and manual transfers produced significantly less thoracolumbar rotation than both the rolling and sliding boards. No other significant differences were observed in cervical or lumbar motion. Motion versus time plots indicated that the log roll maneuvers performed during rolling board and sliding board transfers contributed most of the observed motion. CONCLUSIONS: Each transfer technique produced substantial motion. Transfer techniques that do not include the logroll maneuver can significantly decrease some components of cervical and lumbar motion. Thus, some spinal motion can be reduced through selection of transfer technique.

Does intraoperative neurophysiological monitoring have predictive value for functional recovery following spinal cord injury? A case report.

To present a case report of a patient with an ASIA B spinal cord injury with partially intact baseline IONM who made a complete functional recovery postoperatively. A thirty-three year old male presented after a motor vehicle accident. Imaging studies revealed a C4-C5 bilateral facet dislocation. On presentation the patient had 4/5 strength in bilateral biceps and wrist extensors, 3/5 strength in bilateral triceps, and 0/5 strength in the finger flexors, intrinsics and all lower extremity muscles. Motor level was C7. Sensation was grossly intact to light touch throughout all extremities, intact to pinprick from C2 to T7, and absent to pinprick caudal to T7. Rectal tone and contraction were absent. After attempts at closed reduction failed the patient underwent an open reduction and posterior C4-C5 fusion. Intraoperative neurophysiologic monitoring (IONM) revealed the presence of baseline responses to the posterior tibial nerve using somatosensory evoked potentials and to the right abductor hallucis using transcranial motor evoked potentials. At the 6 weeks postoperative visit the patient had full 5/5 motor strength to all muscles except the left deltoid that was 4/5 due to a rotator cuff injury. This case illustrates a potential prognostic value of IONM. Despite lack of clinical motor function at the time of surgery, IONM was able to illicit a motor response in the right lower extremity. Further prospective studies are needed for further investigation.

Estimating the effective radiation dose imparted to patients by intraoperative cone-beam computed tomography in thoracolumbar spinal surgery.

STUDY DESIGN: Observational. OBJECTIVE: To estimate the radiation dose imparted to patients during typical thoracolumbar spinal surgical scenarios. SUMMARY OF BACKGROUND DATA: Minimally invasive techniques continue to become more common in spine surgery. Computer-assisted navigation systems coupled with intraoperative cone-beam computed tomography (CT) represent one such method used to aid in instrumented spinal procedures. Some studies indicate that cone-beam CT technology delivers a relatively low dose of radiation to patients compared with other x-ray-based imaging modalities. The goal of this study was to estimate the radiation exposure to the patient imparted during typical posterior thoracolumbar instrumented spinal procedures, using intraoperative cone-beam CT and to place these values in the context of standard CT doses. METHODS: Cone-beam CT scans were obtained using Medtronic O-arm (Medtronic, Minneapolis, MN). Thermoluminescence dosimeters were placed in a linear array on a foam-plastic thoracolumbar spine model centered above the radiation source for O-arm presets of lumbar scans for small or large patients. In-air dosimeter measurements were converted to skin surface measurements, using published conversion factors. Dose-length product was calculated from these values. Effective dose was estimated using published effective dose to dose-length product conversion factors. RESULTS: Calculated dosages for many full-length procedures using the small-patient setting fell within the range of published effective doses of abdominal CT scans (1-31 mSv). Calculated dosages for many full-length procedures using the large-patient setting fell within the range of published effective doses of abdominal CT scans when the number of scans did not exceed 3. CONCLUSION: We have demonstrated that single cone-beam CT scans and most full-length posterior instrumented spinal procedures using O-arm in standard mode would likely impart a radiation dose within the range of those imparted by a single standard CT scan of the abdomen. Radiation dose increases with patient size, and the radiation dose received by larger patients as a result of more than 3 O-arm scans in standard mode may exceed the dose received during standard CT of the abdomen. Understanding radiation imparted to patients by cone-beam CT is important for assessing risks and benefits of this technology, especially when spinal surgical procedures require multiple intraoperative scans.

Accuracy of intraoperative computed tomography-based navigation for placement of percutaneous pedicle screws.

MISS techniques have gained recent popularity. The proposed benefits of these techniques include reduced tissue trauma, reduced blood loss, less perioperative pain, and a quicker recovery and return to normal activities. The purpose of this study was to evaluate the accuracy of intraoperative computed tomography (CT)-based navigation for placement of percutaneous pedicle screws in a cadaveric model. Outcome measures included accuracy of screw placement. Two cadaveric specimens were utilized. CT images were obtained using an O-Arm (Medtronic, Memphis, Tennessee, United States) and were coupled to the Stealth navigation system (Medtronic). Computer navigation was used for placement of percutaneous pedicle screws. Screws were placed bilaterally from T5 to S1. Postinsertion CT scans were obtained. Pedicle breach was assessed and classified (I: none, II: < 2 mm, III: 2 to 4 mm, or IV: > 4 mm) with direction of breach. Thirty thoracic screws were placed with 3 (10%) medial breaches and 17 (56.7%) lateral breaches (grade III). Of 20 lumbar screws there were 0 medial breaches and 2 (10%) lateral breaches (1 grade III, 1 grade IV). Four sacral screws were placed without breaches. The real-time computer-aided navigation tool ("simulated screw") was limited in identifying a breach. Manipulation of the surgeon's hand or driver could change the orientation of the navigation tool without changing the screw trajectory. CT-based navigation for percutaneous pedicle screw placement appears safe for the lumbar spine. Lateral thoracic breaches appeared commonly but were not felt to be clinically significant. The 10% rate of medial thoracic breach was concerning, but definitive conclusions could not be made due to the small sample size.

An evidence-based medicine process to determine outcomes after cervical spine trauma: what surgeons should be telling their patients.

STUDY DESIGN: A systematic review of the available medical literature from 1980 to 2010 was conducted and combined with expert opinion from a recent survey of experts regarding cervical spine fractures. Using an objective, hierarchical approach, the best available evidence is presented for health-related quality-of-life outcomes for these injuries. OBJECTIVE: To provide an evidence-based set of guidelines for cervical spine injuries in order to reduce variability in the information given to patients and their families. SUMMARY OF BACKGROUND DATA: Patients' expectations regarding quality-of-life outcomes are highly dependent on the information provided by surgeons early in the treatment course. Our previous work has demonstrated that there is substantial variability in what surgeons tell patients regarding outcomes of cervical spine injuries, thus patients' expectations will differ and outcomes vary. METHODS: Four common cervical spine injuries (C1 burst, Hangman fracture, odontoid fracture, and unilateral facet fracture) treated both surgically and nonsurgically were considered. We assessed the evidence regarding 5 health-related quality-of-life outcomes: time to return to work, activity level, hospital stay, the proportion of patients who are pain free and patients who have regained full range of motion at 1 year after the injury. RESULTS: Published outcome data were available for most injuries. Using consensus expert opinion and the literature, answers to each question were achieved. Overall, expert opinion was relatively homogeneous across injury types, suggesting that experts do not distinguish between specific injuries when advising patients of expected outcomes such as pain. CONCLUSION: By overcoming gaps in the literature with consensus expert opinion, our study provides surgeons and others with evidence-based medicine guidelines for patient-centered outcomes after cervical spine injury. This information can be presented to patients to frame expectations of typical outcomes during and after treatment to optimize patient care and quality of life.

Physician-industry conflict of interest: public opinion regarding industry-sponsored research.

OBJECT: The nature of physician-industry conflict of interest (COI) has become a source of considerable concern, but is often not discussed in the research setting. With reduced funding available from government and nonprofit sources, industry support has enthusiastically grown, but along with this comes the potential for COI that must be regulated. In this era of shared decision making in health care, society must have input into this regulation. The purpose of this study was to assess the opinions of a North American population sample on COI regarding industry-funded research and to analyze population subgroups for trends. METHODS: A survey was developed for face and content validity, underwent focus group evaluation for clarity and bias reduction, and was administered via the World Wide Web. Demographic and general survey results were summarized as a percentage for each answer, and subgroup analysis was done using logistic regression. Generalizability of the sample to the US population was also assessed. RESULTS: Of 541 surveys, 40 were excluded due to missing information, leaving 501 surveys for analysis. The sample population was composed of more females, was older, and was more educated than a representative cross-section of the American population. Respondents support multidisciplinary surgeon-industry COI regulation and trust doctors and their professional societies the most to head this effort. Respondents trust government officials and company representatives the least with respect to regulation of COI. Most respondents feel that industry-sponsored research can involve physicians and be both objective and beneficial to patients. CONCLUSIONS: Most respondents in this study felt that surgeons should be involved in industry-sponsored research and that more research, regardless of funding source, will ultimately benefit patients. The majority of respondents distrust government or industry to regulate COI. The development of evidence-based treatment recommendations requires the inclusion of patient preference. The authors encourage regulatory bodies to follow suit and include society's perspective on regulation of COI in research.

Postoperative infection treatment score for the spine (PITSS): construction and validation of a predictive model to define need for single versus multiple irrigation and debridement for spinal surgical site infection.

BACKGROUND CONTEXT: There is very little evidence to guide treatment of patients with spinal surgical site infection (SSI) who require irrigation and debridement (I&D) in deciding need for single or multiple I&Ds or more complex wound management such as vacuum-assisted closure dressing or soft-tissue flaps. PURPOSE: The purpose of this study was to build a predictive model that stratifies patients with spinal SSI, allowing us to determine which patients will need single versus multiple I&D. The model will be validated and will serve as evidence to support a scoring system to guide treatment. STUDY DESIGN: A consecutive series of 128 patients from a tertiary spine center (collected from 1999 to 2005) who required I&D for spinal SSI were studied based on data from a prospectively collected outcomes database. METHODS: More than 30 variables were identified by extensive literature review as possible risk factors for SSI and tested as possible predictors of risk for multiple I&D. Logistic regression was conducted to assess each variable's predictability by a "bootstrap" statistical method. A prediction model was built in which single or multiple I&D was treated as the "response" and risk factors as "predictors." Next, a second series of 34 different patients meeting the same criteria as the first population were studied. External validation of the predictive model was performed by applying the model to the second data set, and predicted probabilities were generated for each patient. Receiver operating characteristic curves were constructed, and the area under the curve (AUC) was calculated. RESULTS: Twenty-four of one hundred twenty-eight patients with spinal SSI required multiple I&D. Six predictors: anatomical location, medical comorbidities, specific microbiology of the SSI, the presence of distant site infection (ie, urinary tract infection or bacteremia), the presence of instrumentation, and the bone graft type proved to be the most reliable predictors of need for multiple I&D. Internal validation of the predictive model yielded an AUC of 0.84. External validation analysis yielded AUC of 0.70 and 95% confidence interval of 0.51 to 0.89. By setting a probability cutoff of .24, the negative predictive value (NPV) for multiple I&D was 0.77 and positive predictive value (PPV) was 0.57. A probability cutoff of .53 yielded a PPV of 0.85 and NPV of 0.46. CONCLUSIONS: Patients with positive methicillin-resistant Staphylococcus aureus culture or those with distant site infection such as bacteremia were strong predictors of need for multiple I&D. Presence of instrumentation, location of surgery in the posterior lumbar spine, and use of nonautograft bone graft material predicted multiple I&D. Diabetes also proved to be the most significant medical comorbidity for multiple I&D. The validation of this predictive model revealed excellent PPV and good NPV with appropriately chosen probability cutoff points. This study forms the basis for an evidence-based classification system, the Postoperative Infection Treatment Score for the Spine that stratifies patients who require surgery for SSI, based on specific spine, patient, infection, and surgical factors to assess a low, indeterminate, and high risk for the need for multiple I&D.

Morbidity and mortality of major adult spinal surgery. A prospective cohort analysis of 942 consecutive patients.

BACKGROUND CONTEXT: To date, most reports on the incidence of adverse events (AEs) in spine surgery have been retrospective and dependent on data abstraction from hospital-based administrative databases. To our knowledge, there have been no previous rigorously performed prospective analysis of all AEs occurring in the entire population of patients presenting to an academic quaternary referral center. PURPOSE: To determine the mortality and true incidence and severity of morbidity (major and minor, medical and surgical) in adults undergoing complex spinal surgery, both trauma and elective, in a quaternary referral center. To examine the influence of the introduction of a dedicated weekly multidisciplinary rounds, and a formal abstraction tool, on the recording of this prospective perioperative morbidity data. To examine the validity and inter- and intraobserver reliability of a dedicated Spine AdVerse Events Severity system, version 2 (SAVES V2) AE abstraction tool. STUDY DESIGN: Ours is an academic quaternary referral center serving a population of 4.5 million people. Beginning in April 2008, a spine-specific AE-recording instrument, entitled SAVES V2, was introduced at our center for reporting, categorization, and classification of AEs. The use of this system remains an ongoing prospective study. PATIENT SAMPLE: All adult patients admitted to the spine service of a quaternary referral center for a 12-month period. OUTCOME MEASURES: A validity and an inter- and intraobserver reliability examination of the SAVES V2 system, as used at our institution. Morbidity and inhospital deaths, unplanned second surgeries during index admission, wound infections requiring reoperation, and readmissions during the same calendar year. We also examined in detail all intraoperative and nonsurgical postoperative AEs, as well as hospital length of stay (LOS). METHODS: Data on all patients undergoing surgery over a 12-month period were prospectively collected using a perioperative morbidity abstraction tool at weekly dedicated mortality and morbidity rounds. This tool allows identification of each specific AE and grades the severity. Before the introduction of this system, and using the hospital inpatient database, our documented perioperative morbidity rate (major and minor, medical and surgical) was 23%. Diagnosis, operative data, hospital data, major and minor complications both medical and surgical, and deaths were recorded. RESULTS: One hundred percent of all patients discharged from the unit had complete data available for analysis. Nine hundred forty-two patients with an age range of 16 to 90 years (mean, 54 years; mode, 38 years) were identified. There were 552 males and 390 females. Around 58.5% of patients had undergone elective surgery. Thirty percent of patients were American Spinal Injury Association class D or worse on admission. The average LOS was 13.5 days (range, 1-221 days). Eight hundred twenty-two (87%) patients had at least one documented complication. Thirty-nine percent of these adversely affected hospital LOS. There were 14 mortalities during the study period. The rate of intraoperative surgical complication was 10.5% (4.5% incidental durotomy and 1.9% hardware malposition requiring revision and 2.2% blood loss >2 L). The incidence of postoperative complication was 73.5% (wound complications, 13.5%; delerium, 8%; pneumonia, 7%; neuropathic pain, 5%; dysphagia, 4.5%; and neurological deterioration, 3%). CONCLUSIONS: Major spinal surgery in the adult is associated with a high incidence of intra- and postoperative complications. We identified a very high rate of previously unrecognized postoperative complications, which adversely affect LOS. Without strict adherence to a prospective data collection system, the true complexity of this surgery may be greatly underestimated.

Spinal instability neoplastic score: an analysis of reliability and validity from the spine oncology study group.

PURPOSE: Standardized indications for treatment of tumor-related spinal instability are hampered by the lack of a valid and reliable classification system. The objective of this study was to determine the interobserver reliability, intraobserver reliability, and predictive validity of the Spinal Instability Neoplastic Score (SINS). METHODS: Clinical and radiographic data from 30 patients with spinal tumors were classified as stable, potentially unstable, and unstable by members of the Spine Oncology Study Group. The median category for each patient case (consensus opinion) was used as the gold standard for predictive validity testing. On two occasions at least 6 weeks apart, each rater also scored each patient using SINS. Each total score was converted into a three-category data field, with 0 to 6 as stable, 7 to 12 as potentially unstable, and 13 to 18 as unstable. RESULTS: The κ statistics for interobserver reliability were 0.790, 0.841, 0.244, 0.456, 0.462, and 0.492 for the fields of location, pain, bone quality, alignment, vertebral body collapse, and posterolateral involvement, respectively. The κ statistics for intraobserver reliability were 0.806, 0.859, 0.528, 0.614, 0.590, and 0.662 for the same respective fields. Intraclass correlation coefficients for inter- and intraobserver reliability of total SINS score were 0.846 (95% CI, 0.773 to 0.911) and 0.886 (95% CI, 0.868 to 0.902), respectively. The κ statistic for predictive validity was 0.712 (95% CI, 0.676 to 0.766). CONCLUSION: SINS demonstrated near-perfect inter- and intraobserver reliability in determining three clinically relevant categories of stability. The sensitivity and specificity of SINS for potentially unstable or unstable lesions were 95.7% and 79.5%, respectively.