Generating the American Shoulder and Elbow Surgeons Score Using Multivariable Predictive Models and Computer Adaptive Testing to Reduce Survey Burden.

BACKGROUND: The preferred patient-reported outcome measure for the assessment of shoulder conditions continues to evolve. Previous studies correlating the Patient-Reported Outcomes Measurement Information System (PROMIS) computer adaptive tests (CATs) to the American Shoulder and Elbow Surgeons (ASES) score have focused on a singular domain (pain or physical function) but have not evaluated the combined domains of pain and physical function that compose the ASES score. Additionally, previous studies have not provided a multivariable prediction tool to convert PROMIS scores to more familiar legacy scores. PURPOSE: To establish a valid predictive model of ASES scores using a nonlinear combination of PROMIS domains for physical function and pain. STUDY DESIGN: Cohort study (Diagnosis); Level of evidence, 3. METHODS: The Military Orthopaedics Tracking Injuries and Outcomes Network (MOTION) database is a prospectively collected repository of patient-reported outcomes and intraoperative variables. Patients in MOTION research who underwent shoulder surgery and completed the ASES, PROMIS Physical Function, and PROMIS Pain Interference at varying time points were included in the present analysis. Nonlinear multivariable predictive models were created to establish an ASES index score and then validated using "leave 1 out" techniques and minimal clinically important difference /substantial clinical benefit (MCID/SCB) analysis. RESULTS: A total of 909 patients completed the ASES, PROMIS Physical Function, and PROMIS Pain Interference at presurgery, 6 weeks, 6 months, and 1 year after surgery, providing 1502 complete observations. The PROMIS CAT predictive model was strongly validated to predict the ASES (Pearson coefficient = 0.76-0.78; R2 = 0.57-0.62; root mean square error = 13.3-14.1). The MCID/SCB for the ASES was 21.7, and the best ASES index MCID/SCB was 19.4, suggesting that the derived ASES index is effective and can reliably re-create ASES scores. CONCLUSION: The PROMIS CAT predictive models are able to approximate the ASES score within 13 to 14 points, which is 7 points more accurate than the ASES MCID/SCB derived from the sample. Our ASES index algorithm, which is freely available online (https://osf.io/ctmnd/), has a lower MCID/SCB than the ASES itself. This algorithm can be used to decrease patient survey burden by 11 questions and provide a reliable ASES analog to clinicians.

VA/DoD Clinical Practice Guideline: Diagnosis and Treatment of Low Back Pain.

DESCRIPTION: In September 2017, the U.S. Department of Veterans Affairs (VA) and U.S. Department of Defense (DoD) approved the joint Clinical Practice Guideline (CPG) for Diagnosis and Management of Low Back Pain. This CPG was intended to provide healthcare providers a framework by which to evaluate, treat, and manage patients with low back pain (LBP). METHODS: The VA/DoD Evidence-Based Practice Work Group convened a joint VA/DoD guideline development effort that included a multidisciplinary panel of practicing clinician stakeholders and conformed to the Institute of Medicine's tenets for trustworthy clinical practice guidelines. The guideline panel developed key questions in collaboration with the ECRI Institute, which systematically searched and evaluated the literature through September 2016, developed an algorithm, and rated recommendations by using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system. A patient focus group was also convened to ensure patient values and perspectives were considered when formulating preferences and shared decision making in the guideline. RECOMMENDATIONS: The VA/DOD LBP CPG provides evidence-based recommendations for the diagnostic approach, education and self-care, non-pharmacologic and non-invasive therapy, pharmacologic therapy, dietary supplements, non-surgical invasive therapy, and team approach to treatment of low back pain.

Knee Disarticulations Versus Transfemoral Amputations: Functional Outcomes.

OBJECTIVES: To determine whether there is a patient-reported functional difference between combat-related knee disarticulations (KDs) and transfemoral amputations (TFAs). SETTING: Role 3 Military Trauma Centers. PATIENTS: We identified and contacted all KDs and TFAs performed at the Walter Reed National Military Medical Center, Walter Reed Army Medical Center, and National Naval Medical Center from January 2003 until July 2012 to participate in a retrospective functional cohort analysis. Ten KD patients were available for study completion and were matched against 18 patients in the TFA group. INTERVENTION: Knee disarticulation versus transfemoral amputation. MAIN OUTCOME MEASUREMENTS: The following surveys were obtained from the participants-AAOS Lower Limb Outcome Questionnaire (LLQ), Tegner Activity Scale, SF-36, and Prosthetic Evaluation Questionnaires (PEQs). RESULTS: Ten KD patients agreed to participate in the study, and 18 TFA matched controls were interviewed. Patients were followed up at an average of 66 months (interquartile range 50-79 months) after injury. There were no significant differences with regard to the SF-36, PEQ, LLQ, and Tegner Activity Scale scores. CONCLUSIONS: We detected no functional differences measured on the PEQ, LLQ, SF-36, and Tegner Activity Scale scores between KDs and TFAs. In the absence of a proven functional difference, we advocate performing trauma-related amputations at the most distal level the osseous and soft tissue injuries permit. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Effects of rod reduction on pedicle screw fixation strength in the setting of Ponte osteotomies.

BACKGROUND CONTEXT: The use of a rod reduction device can have deleterious consequences on pedicle screw pullout strength (POS) in the thoracic spine. However, posterior-only osteotomies in the thoracic spine are often performed to improve flexibility of the spine and offset forces of deformity correction maneuvers. PURPOSE: To investigate the effect on pedicle screw POS caused by the rod reduction technique in the presence of facet osteotomies in the thoracic spine. STUDY DESIGN/SETTING: The study is a biomechanical study using human cadaveric spine specimens. METHODS: Thoracic Ponte osteotomies were performed on 3 thoracic levels in 15 cadaveric specimens. The right rod was contoured with a 5-mm residual gap at the middle level and was reduced using a rod reduction device. On the left side (paired control), a rod with no mismatch was placed. Biomechanical testing was performed with tensile load to failure "in line" with the screw axis and POS measured in Newtons (N). RESULTS: After rod reduction, thoracic pedicle screw POS was significantly decreased (40%) compared with the control (419±426 N vs. 708±462 N, p=.002) and remained statistically significant after adjusting for bone mineral density (BMD) (p=.05). Eleven (73%) of the pedicle screws had visible pullout/failure during the reduction attempt and occurred irrespective of BMD. CONCLUSIONS: Despite thoracic Ponte osteotomies and increased flexibility of the spinal segments, the rod reduction device still significantly decreased pedicle screw POS, typically resulting in outright failure of the screw-bone interface. Therefore, rod reduction technique of any kind should be performed with caution as it frequently results in suboptimal pedicle screw fixation.

Return to sports after surgery to correct adolescent idiopathic scoliosis: a survey of the Spinal Deformity Study Group.

BACKGROUND CONTEXT: There are no guidelines for when surgeons should allow patients to return to sports and athletic activities after spinal fusion for adolescent idiopathic scoliosis (AIS). Current recommendations are based on anecdotal reports and a survey performed more than a decade ago in the era of first/second-generation posterior implants. PURPOSE: To identify current recommendations for return to sports and athletic activities after surgery for AIS. STUDY DESIGN/SETTING: Questionnaire-based survey. PATIENT SAMPLE: Adolescent idiopathic scoliosis after corrective surgery. OUTCOME MEASURES: Type and time to return to sports. METHODS: A survey was administered to members of the Spinal Deformity Study Group. The survey consisted of surgeon demographic information, six clinical case scenarios, three different construct types (hooks, pedicle screws, hybrid), and questions regarding the influence of lowest instrumented vertebra (LIV) and postoperative physical therapy. RESULTS: Twenty-three surgeons completed the survey, and respondents were all experienced expert deformity surgeons. Pedicle screw instrumentation allows earlier return to noncontact and contact sports, with most patients allowed to return to running by 3 months, both noncontact and contact sports by 6 months, and collision sports by 12 months postoperatively. For all construct types, approximately 20% never allow return to collision sports, whereas all surgeons allow eventual return to contact and noncontact sports regardless of construct type. In addition to construct type, we found progressively distal LIV resulted in more surgeons never allowing return to collision sports, with 12% for selective thoracic fusion to T12/L1 versus 33% for posterior spinal fusion to L4. Most respondents also did not recommend formal postoperative physical therapy (78%). Of all surgeons surveyed, there was only one reported instrumentation failure/pullout without neurologic deficit after a patient went snowboarding 2 weeks postoperatively. CONCLUSIONS: Modern posterior instrumentation allows surgeons to recommend earlier return to sports after fusion for AIS, with the majority allowing running by 3 months, noncontact and contact sports by 6 months, and collision sports by 12 months.

Pedicle screw reinsertion using previous pilot hole and trajectory does not reduce fixation strength.

STUDY DESIGN: Fresh-frozen human cadaveric biomechanical study. OBJECTIVE: To evaluate the biomechanical consequence of pedicle screw reinsertion in the thoracic spine. SUMMARY OF BACKGROUND DATA: During pedicle screw instrumentation, abnormal appearance on fluoroscopic imaging or low current reading with intraoperatively evoked electromyographic stimulation of a pedicle screw warrants complete removal to reassess for pedicle wall violation or screw malposition. However, screw fixation strength has never been evaluated biomechanically after reinsertion using a previous pilot hole and trajectory. METHODS: Thirty-one thoracic individual fresh-frozen human cadaveric vertebral levels were instrumented bilaterally with 5.5-mm titanium polyaxial pedicle screws, and insertional torque (IT) was measured with each revolution. A paired comparison was performed for each level. Screw reinsertion was performed by completely removing the pedicle screw, palpating the tract, and then reinserting along the same trajectory. Screws were tensile loaded to failure "in-line" with the screw axis. RESULTS: There was no significant difference for pedicle screw pullout strength (POS) between reinserted and control screws (732 ± 307 N vs. 742 ± 320 N, respectively; P = 0.78). There was no significant difference in IT between initial insertion for the test group (INI) (0.82 ± 0.40 N·m) and control (0.87 ± 0.50 N·m) (P = 0.33). IT for reinserted screws (0.58 ± 0.47 N·m) had significantly decreased compared with INI and control screws (29% decrease, P = 0.00; 33% decrease, P = 0.00, respectively). The test group screws in the thoracic spine had significant correlations between initial IT and POS (r = 0.79, P = 0.00), and moderate correlations between reinsertion IT and POS in the thoracic spine (r = 0.56, P = 0.00). CONCLUSION: Despite a significant reduction in pedicle screw IT, there was no significant difference in pedicle screw POS with reinsertion. Therefore, when surgeons must completely remove a pedicle screw for tract inspection, reinsertion along the same trajectory may be performed without significantly compromising fixation strength. LEVEL OF EVIDENCE: N/A.

The effect of cervical posterior foraminotomy on segmental range of motion in the setting of total disc arthroplasty.

STUDY DESIGN: Human cadaveric biomechanical analysis. OBJECTIVE: To investigate the effect on cervical spine segmental stability that results from a posterior foraminotomy after cervical disc arthroplasty (CDA). SUMMARY OF BACKGROUND DATA: Posterior foraminotomy offers the ability to decompress cervical nerves roots while avoiding the need to extend a previous fusion or revise an arthroplasty to a fusion. However, the safety of a foraminotomy in the setting of CDA is unknown. METHODS: Segmental nondestructive range of motion (ROM) was analyzed in 9 human cadaveric cervical spine specimens. After intact testing, each specimen was sequentially tested according to the following 4 experimental groups: group 1=C5-C6 CDA, group 2=C5-C6 CDA with unilateral C5-C6 foraminotomy, group 3=C5-C6 CDA with bilateral C5-C6 foraminotomy, and group 4=C5-C6 CDA with C5-C6 and C4-C5 bilateral foraminotomy. RESULTS: No differences in ROM were found between the intact, CDA, and foraminotomy specimens at C4-C5 or C6-C7. There was a step-wise increase in C5-C6 axial rotation from the intact state (8°) to group 4 (12°), although the difference did not reach statistical significance. At C5-C6, the degree of lateral bending remained relatively constant. Flexion and extension at C5-C6 was significantly higher in the foraminotomy specimens, groups 2 (18.1°), 3 (18.6°), and 4 (18.2°), compared with the intact state, 11.2°. However, no ROM difference was found within foraminotomy groups (2-4) or between the foraminotomy groups and the CDA group (group 1), 15.3°. CONCLUSION: Our results indicate that cervical stability is not significantly decreased by the presence, number, or level of posterior foraminotomies in the setting of CDA. The addition of foraminotomies to specimens with a pre-existing CDA resulted in small and insignificant increases in segmental ROM. Therefore, biomechanically, posterior foraminotomy/foraminotomies may be considered a safe and viable option in the setting of recurrent or adjacent level radiculopathy after cervical disc replacement. LEVEL OF EVIDENCE: N/A.

Systematic review and meta-analysis of minimally invasive transforaminal lumbar interbody fusion rates performed without posterolateral fusion.

The need for posterolateral fusion (PLF) in addition to interbody fusion during minimally invasive (MIS) transforaminal lumbar interbody fusion (TLIF) has yet to be established. Omitting a PLF significantly reduces overall surface area available for achieving a solid arthrodesis, however it decreases the soft tissue dissection and costs of additional bone graft. The authors sought to perform a meta-analysis to establish the fusion rate of MIS TLIF performed without attempting a PLF. We performed an extensive Medline and Ovid database search through December 2010 revealing 39 articles. Inclusion criteria necessitated that a one or two level TLIF procedure was performed through a paramedian MIS approach with bilateral posterior pedicle screw instrumentation and without posterolateral bone grafting. CT scan verified fusion rates were mandatory for inclusion. Seven studies (case series and case-controls) met inclusion criteria with a total of 408 patients who underwent MIS TLIF as described above. The mean age was 50.7 years and 56.6% of patients were female. A total of 78.9% of patients underwent single level TLIF. Average radiographic follow-up was 15.6 months. All patients had local autologous interbody bone grafting harvested from the pars interarticularis and facet joint of the approach side. Either polyetheretherketone (PEEK) or allograft interbody cages were used in all patients. Overall fusion rate, confirmed by bridging trabecular interbody bone on CT scan, was 94.7%. This meta-analysis suggests that MIS TLIF performed with interbody bone grafting alone has similar fusion rates to MIS or open TLIF performed with interbody supplemented with posterolateral bone grafting and fusion.

Pedicle screw "hubbing" in the immature thoracic spine: a biomechanical and micro-computed tomography evaluation.

BACKGROUND: A previous biomechanical study using adult thoracic vertebrae (both normal and osteoporotic bone density) demonstrated the deleterious effect of the pedicle screw hubbing technique. Pedicle screw "hubbing" involves seating and engaging the ventral aspect of the screw head onto the dorsal lamina cortex. This technique is postulated to provide a load-sharing effect by improving pullout resistance, as well as decreasing cephalocaudad toggling and implant loosening. We hypothesized the elastic properties of immature bone may mitigate, and perhaps enhance the purported benefits of the hubbing technique. We set out to evaluate pullout strength of fixed-head pedicle screws after hubbing versus standard insertion in the immature thoracic calf spine. METHODS: Twenty-two (n=22) single-level disarticulated fresh-frozen immature calf thoracic vertebra specimens (ranging from T2 to T13) were prepared. Twelve specimens were instrumented with pedicle screws in group I (nonhubbed) and group II (hubbed) in the opposite pedicle. Cyclic loading in a cephalocaudad direction was applied for 2000 cycles at a rate of 1 Hz. Pullout testing was performed in-line with the midline of the vertebra and peak pullout strength was measured in Newtons. Ten different specimens underwent micro-computed tomography evaluation to assess for trabecular architecture and incidence of iatrogenic microfractures. RESULTS: Hubbed screws resulted in significantly lower pullout strength (747±197 vs. 922±112 N, P=0.01). With the hubbing technique, the dorsal cortex demonstrated plastic deformation and conformed to the screw head in 83% of cases compared with no visible plastic deformation in the control group. Micro-computed tomography demonstrated microfractures of the dorsal cortex in 10/10 for the hubbed group compared with 1/10 for the control group. CONCLUSIONS: This is the largest study ever performed on immature thoracic vertebra to evaluate this topic. Hubbed pedicle screws have significantly decreased pullout strength and frequently cause iatrogenic microfractures of the dorsal cortex. The unique ability of immature bone to exhibit plastic deformation did not provide a protective effect on immediate fixation strength, and the increased insertional torque during the hubbing technique should not give a false sense of added fixation. This study, along with our adult study, provides critical information to the surgeon to avoid this common misunderstanding with screw insertion technique. CLINICAL RELEVANCE: In vitro fresh-frozen immature calf spine study.

Incidence and morbidity of concomitant spine fractures in combat-related amputees.

BACKGROUND CONTEXT: High-energy blasts are the most frequent cause of combat-related amputations in Operations Iraqi and Enduring Freedom (OIF/OEF). The nondiscriminating effects of this mechanism often result in both appendicular and axial skeletal injuries. Despite this recognized coincident injury pattern, the incidence and consequence of spine fractures in trauma-related combat amputees are unknown. PURPOSE: This study sought to determine the incidence and morbidity of the associated spine fractures on patients with traumatic lower extremity amputation sustained during OIF/OEF. STUDY DESIGN/SETTING: Retrospective case control. PATIENT SAMPLE: Two hundred twenty-six combat-related lower extremity amputees presenting to a single institution and injured between 2003 and 2008 were included for analysis. OUTCOME MEASURES: Physiologic and functional outcome measures were used to determine the influence of spine fractures on combat amputees. Physiologic measures included intensive care unit (ICU) admission rates, injury severity score (ISS), rate of narcotic/neuropathic pain use, and heterotopic ossification (HO) rates. Functional outcome measures included return-to-duty rates and ambulatory status at final follow-up. METHODS: Data from 300 consecutive combat-related lower extremity amputations were retrospectively reviewed and grouped. Group 1 consisted of amputees with associated spine fractures, and Group 2 consisted of amputees without spine fractures. The results of the two groups were compared with regard to initial presentation and final functional outcomes. RESULTS: A total of 226 patients sustained 300 lower extremity amputations secondary to combat-related injuries, the most common mechanism being an improvised explosive device. Twenty-nine of these patients had a spine fracture (13%). Group 1 had a higher ISS than Group 2 (30 vs. 19, p<.001). Group 1 patients were also more likely to be admitted to the ICU (86% vs. 46%, p<.001). Furthermore, Group 1 patients had a significantly higher rate of HO in their residual limbs (82% vs. 55%, p<.005). CONCLUSIONS: The incidence of spine fractures in combat-related amputees is 13%. The results suggest that combat-related amputees with spine fractures are more likely to sustain severe injuries to other body systems, as indicated by the significantly higher ISS and rates of ICU admission. This group also had a significantly higher rate of HO formation, which may be attributable to the greater local and/or systemic injuries sustained by these patients.

A model to predict limb salvage in severe combat-related open calcaneus fractures.

BACKGROUND: Open calcaneus fractures can be limb threatening and almost universally result in some measure of long-term disability. A major goal of initial management in patients with these injuries is setting appropriate expectations and discussing the likelihood of limb salvage, yet there are few tools that assist in predicting the outcome of this difficult fracture pattern. QUESTIONS/PURPOSES: We developed two decision support tools, an artificial neural network and a logistic regression model, based on presenting data from severe combat-related open calcaneus fractures. We then determined which model more accurately estimated the likelihood of amputation and which was better suited for clinical use. METHODS: Injury-specific data were collected from wounded active-duty service members who sustained combat-related open calcaneus fractures between 2003 and 2012. One-hundred fifty-five open calcaneus fractures met inclusion criteria. Median followup was 3.5 years (interquartile range: 1.5, 5.1 years), and amputation rate was 44%. We developed an artificial neural network designed to estimate the likelihood of amputation, using information available on presentation. For comparison, a conventional logistic regression model was developed with variables identified on univariate analysis. We determined which model more accurately estimated the likelihood of amputation using receiver operating characteristic analysis. Decision curve analysis was then performed to determine each model's clinical utility. RESULTS: An artificial neural network that contained eight presenting features resulted in smaller error. The eight features that contributed to the most predictive model were American Society of Anesthesiologist grade, plantar sensation, fracture treatment before arrival, Gustilo-Anderson fracture type, Sanders fracture classification, vascular injury, male sex, and dismounted blast mechanism. The artificial neural network was 30% more accurate, with an area under the curve of 0.8 (compared to 0.65 for logistic regression). Decision curve analysis indicated the artificial neural network resulted in higher benefit across the broadest range of threshold probabilities compared to the logistic regression model and is perhaps better suited for clinical use. CONCLUSIONS: This report demonstrates an artificial neural network was capable of accurately estimating the likelihood of amputation. Furthermore, decision curve analysis suggested the artificial neural network is better suited for clinical use than logistic regression. Once properly validated, this may provide a tool for surgeons and patients faced with combat-related open calcaneus fractures in which decisions between limb salvage and amputation remain difficult.

Sequential free tissue transfers for simultaneous upper and lower limb salvage.

BACKGROUND: The Iraq and Afghanistan Wars have presented military reconstructive surgeons with a high volume of challenging extremity injuries. In recent years, a number of upper and lower extremity injuries requiring multiple tissue transfers for multiple limb salvages in the same casualty have been encountered. Our group will discuss the microsurgical challenges, algorithms, and success and complication rates for this cohort of war injured patients. METHODS: All consecutive limb salvage cases requiring free flaps from 2003 to 2012 were reviewed. Cases involving simultaneous free tissue transfers were identified. Data collected included success rates and complications with comparisons made between the single and multiple free-flap limb salvage cohorts. RESULTS: Seventy-four free flap limb salvage cases were performed over the 10-year period. Of these cases, four patients received two free flaps to separate upper and lower extremity injuries for limb salvage within a single operative setting. The complication rate was 63%, which was significantly higher than those cases in which a single microvascular anastomosis was performed (26%, p = 0.046). However, the higher complication rate did not increase the flap or limb salvage failure rates (p = 0.892 and 0.626). CONCLUSIONS: The last decade of war trauma has provided a high volume of extremity injuries requiring limb salvage procedures including casualties who underwent single and multiple free flap coverage procedures. Although multiple flap limb salvage procedures have a higher complication rate, they can be performed within the same patient without concern for increased failure rate in carefully selected and appropriately managed patients.

Outcomes following cervical disc arthroplasty in an active duty military population.

Symptomatic cervical radiculopathy is a common problem in the active duty military population and can cause significant disability leading to limited duty status and loss of operational readiness and strength. Based on their increasing experience with cervical disc arthroplasty (CDA) in this unique patient population, the authors set out to further evaluate the outcomes and complications of CDA in active duty military patients. A retrospective review of a single military tertiary medical center was performed between August 2008 and August 2012 and the clinical outcomes of patients who underwent cervical disc arthroplasty were evaluated. There were 37 active duty military patients, with a total of 41 CDA. The study found good relief of preoperative symptoms (92%) and the ability to maintain operational readiness with a high rate of return to full unrestricted duty (95%) with an average follow-up of 6 months. There was a low rate of complications related to the anterior cervical approach (5%-8%), with no device- or implant-related complications.

Update on the evidence for adjacent segment degeneration and disease.

BACKGROUND CONTEXT: The evidence surrounding the topic of adjacent segment degeneration and disease has increased dramatically with an abundant amount of literature discussing the incidence of and techniques to avoid it. However, this evidence is often confusing to discern because of various definitions of both adjacent segment degeneration and disease. PURPOSE: To organize and review the recent evidence for adjacent segment degeneration and disease. RESULTS: Although multifactorial, three distinct causes of adjacent segment disease in both the lumbar and cervical spine have been discussed: the natural history of the adjacent disc; biomechanical stress on the adjacent level caused by the fusion; and disruption of the anatomy at the adjacent level with the initial surgery. The incidence of adjacent segment degeneration in the lumbar spine has been widely reported in the literature from 0% to 100%; conversely, the reported incidence in the cervical spine is less variable. Similarly, strategies at avoiding adjacent segment disease in the lumbar spine include arthroplasty, dynamic fixation, and percutaneous fixation, whereas in the cervical spine the focus has remained on arthroplasty. CONCLUSIONS: Adjacent segment disease and degeneration remain a multifactorial problem with several techniques being developed recently to minimize them. In the future, it is likely that the popularity of these techniques will be dependent on the long-term results, which are currently unavailable.

A systematic review of cervical artificial disc replacement wear characteristics and durability.

STUDY DESIGN: Systematic review.Clinical questions: (1) What evidence is available from studies of cervical total disc arthroplasty (C-ADR) failure and retrieval regarding durability, wear, and reasons for failure of C-ADR? (2) What evidence is available from experimental models regarding the durability of C-ADR beyond 5 years? METHODS: We searched electronic databases to identify published reports of explanted cervical artificial discs and biomechanical simulations of disc wear. RESULTS: Nine articles were identified describing 17 devices explanted from human patients and four articles describing 23 devices explanted from non-human subjects. Wear properties were not consistently reported across studies, so summaries for specific variables are based on few cases. No device had been implanted longer than 4 years. In both human and non-human subjects, devices showed evidence of metallic and polymeric (for discs with polymer components) debris. Inflammatory cells were frequently present in surrounding soft tissues. Signs of infection were uncommon.Four patients had reactions interpreted as hypersensitivity to metal. We identified three articles on biomechanical wear simulations. Devices were tested between 10 and 20 million cycles in axial loading, flexion/extension, and lateral bending. No device failures were reported. One study suggests such simulations may represent 50 or more years of wear in actual patients. CONCLUSION: Cervical disc implants consistently produced polymeric and metallic debris, which was typically accompanied by inflammation. Hypersensitivity to metal may increase risk for device failure. Biomechanical simulations indicate that cervical disc implants may be durable beyond the currently reported length of clinical follow-up.

What is the best way to optimize thoracic kyphosis correction? A micro-CT and biomechanical analysis of pedicle morphology and screw failure.

STUDY DESIGN: A human cadaveric biomechanical analysis. OBJECTIVE: The purpose of this study was to evaluate the bone density/trabecular width of the thoracic pedicle and correlate that with its resistance against compressive loading used during correction maneuvers in the thoracic spine (i.e., cantilever bending). SUMMARY OF BACKGROUND DATA: As surgeons perform cantilever correction maneuvers in the spine, it is common to have pedicle screws pullout or displace while placing corrective forces on the construct. Currently, surgeons either compress against the cephalad aspect of the pedicle or vice versa. We set out to establish which aspect of the pedicle was the most dense and to determine the optimal direction for screw compression during kyphosis/deformity correction. METHODS: Fifteen fresh-frozen cadaveric vertebrae (n = 15) were examined by micro-computed tomography to determine percent bone volume/total volume (%BV/TV) within the cephalad and caudad aspects of the pedicle. Specimens were sectioned in the sagittal plane. Pedicles were instrumented according to the straightforward trajectory on both sides. Specimens were then mounted and loading to failure was performed perpendicular to the screw axis (either the cephalad or the caudad aspect of the pedicle). RESULTS: Mean failure when loading against the caudad aspect of the pedicle was statistically, significantly greater (454.5 ± 241.3 N vs. 334.79 1 ± 158.435 N) than for the cephalad pedicle (P < 0.001). In concordance with failure data, more trabecular and cortical bones were observed within the caudad half of the pedicle compared with the cephalad half (P < 0.001). CONCLUSION: Our results suggest that the caudad half of the pedicle is denser and withstands higher forces compared with the cephalad aspect. In turn, the incidence of intraoperative screw loosening and/or pedicle fracture may be reduced if the compressive forces (cantilever bending during deformity correction) placed upon the construct are applied against the caudad portion of the pedicle.