Thermal Damage in Orthopaedics.

There are numerous potential sources of thermal damage encountered in orthopaedic surgery. An understanding of the preclinical mechanisms of thermal damage in tissues is necessary to minimize iatrogenic injuries and use these mechanisms therapeutically. Heat generation is a phenomenon that can be used to a surgeon's benefit, most commonly for hemostasis and local control of tumors. It is simultaneously one of the most dangerous by-products of orthopaedic techniques as a result of burring, drilling, cementation, and electrocautery and can severely damage tissues if used improperly. Similarly, cooling can be used to a surgeon's advantage in some orthopaedic subspecialties, but the potential for harm to tissues is also great. Understanding the potential of a given technique to rapidly alter local temperature-and the range of temperatures tolerated by a given tissue-is imperative to harness the power of heat and cold. In all subspecialties of orthopaedic surgery, thermal damage is a relevant topic that represents a direct connection between preclinical and clinical practice.

Are all Cages Created Equal? Analysis of Cervical Cage Malfunctions Using FDA MAUDE Database.

STUDY DESIGN: Retrospective case series. OBJECTIVE: To characterize failure rates of cervical cages based on manufacturer and design characteristics using the nationwide database of reported malfunctions. BACKGROUND: The Food and Drug Administration (FDA) aims to ensure the safety and efficacy of cervical interbody implants postimplantation; however, intraoperative malfunctions may be overlooked. MATERIALS AND METHODS: The FDA's Manufacturer and User Facility Device Experience database was queried for reports of cervical cage device malfunctions from 2012 to 2021. Each report was categorized based on the failure type, implant design, and manufacturer. Two market analyses were performed. First, "failure-to-market share indices" were generated by dividing the number of failures per year for each implant material by its yearly US market share in cervical spine fusion. Second, "failure-to-revenue indices" were calculated by dividing the total number of failures per year for each manufacturer by their approximate yearly revenue from spinal implants in the US. Outlier analysis was performed to generate a threshold value above which failure rates were defined as greater than the normal index. RESULTS: In total, 1336 entries were identified, and 1225 met the inclusion criteria. Of these, 354 (28.9%) were cage breakages, 54 (4.4%) were cage migrations, 321 (26.2%) were instrumentation-related failures, 301 (24.6%) were assembly failures, and 195 (15.9%) were screw failures. Poly-ether-ether-ketone implants had higher failure by market share indices for both migration and breakage compared with titanium. Upon manufacturer market analysis, Seaspine, Zimmer-Biomet, K2M, and LDR exceeded the failure threshold. CONCLUSION: The most common cause of implant malfunction was breakage. Poly-ether-ether-ketone cages were more likely to break and migrate compared with titanium ones. Many of these implant failures occurred intraoperatively during instrumentation, which underscores the need for FDA evaluation of these implants and their accompanying instrumentation under the appropriate loading conditions before commercial approval.

Laminoplasty in Motion: Evolving Techniques and Complications.

Cervical laminoplasty is an increasingly popular surgical option for the treatment of cervical spondylotic myelopathy (CSM) and ossification of the posterior longitudinal ligament (OPLL). Over the past few decades, there have been substantial developments in both surgical technique and hardware options. As the field of cervical surgery rapidly evolves, there is a timely need to reassess the evolving complications associated with newer techniques. This review aims to synthesize the available literature on cervical laminoplasty and associated mechanical complications pertaining to different laminoplasty hinge fixation options.

Spinolaminar locking plates improve fixation strength compared to pedicle screws: a biomechanical analysis.

INTRODUCTION: Pedicle screw loosening is a significant complication of posterior spinal fixation, particularly among osteoporotic patients and in deformity constructs. In orthopedic trauma surgery, locking plates and screws have revolutionized the fixation of osteoporotic fractures. We have combined the traumatology principle of fixed-angle locking plate fixation with the spine principles of segmental instrumentation. METHODS: A novel spinolaminar locking plate was designed based on morphometric studies of human thoracolumbar vertebrae. The plates were fixed to cadaveric human lumbar spines and connected to form 1-level L1-L2 or L4-L5 constructs and compared to similar pedicle screw constructs. Pure moment testing was performed to assess range of motion before and after 30,000 cycles of cyclic fatigue. Post-fatigue fixture pullout strength was assessed by applying a continuous axial tensile force oriented to the principal axis of the pedicle until pullout was observed. RESULTS: Spinolaminar plate fixation resulted in superior pullout strength compared to pedicle screws (1,065 ± 400N vs. 714 ± 284N, p = 0.028). Spinolaminar plates performed equivalently to pedicle screws in range of motion reduction during flexion/extension and axial rotation. Pedicle screws outperformed the spinolaminar plates in lateral bending. Finally, no spinolaminar constructs failed during cyclic fatigue testing, whereas one pedicle screw construct did. CONCLUSIONS: The spinolaminar locking plate maintained adequate fixation post-fatigue, particularly in flexion/extension and axial rotation compared to pedicle screws. Moreover, spinolaminar plates were superior to pedicle screw fixation with respect to cyclic fatiguing and pullout strength. The spinolaminar plates offer a viable option for posterior lumbar instrumentation in the adult spine.

An Analysis of a Decade of Lumbar Interbody Cage Failures in the United States: A MAUDE Database Study.

STUDY DESIGN: A retrospective case series. OBJECTIVE: This study aims to assess the rates of lumbar interbody cage failures based on their material and manufacturer. SUMMARY OF BACKGROUND DATA: Perioperative lumbar interbody cage malfunctions are underreported events in the spine literature and may result in complications. Although the Food and Drug Administration ensures the safety of these devices under physiological conditions after implantation, these devices may experience nonphysiological conditions during implantation, which may be overlooked. MATERIALS AND METHODS: The MAUDE database was examined for reports of lumbar cage device malfunctions from 2012 to 2021. Each report was categorized based on failure type and implant design. A market analysis was performed by dividing the total number of failures per year for each manufacturer by their approximate yearly revenue from spinal implants in the United States. Outlier analysis was performed to generate a threshold value above which failure rates were defined as greater than the normal index. RESULTS: Overall, 1875 lumbar cage malfunctions were identified. Of these, 1230 (65.6%) were cage breakages, 257 (13.7%) were instrument malfunctions, 177 (9.4%) were cage migrations, 143 (7.6%) were assembly failures, 70 (4.5%) were screw-related failures, and 21 (1.1%) were cage collapses. Of the breakages, 923 (74.9%) occurred during insertion or impaction and 97 entries detailed a medical complication or a retained foreign body. Of the migrations, 155 (88.6%) were identified postoperatively, of which 73 (47.1%) detailed complications and 52 (33.5%) required a revision procedure. Market analysis demonstrated that Medtronic, Zimmer Biomet, Stryker, Seaspine, and K2M exceeded the calculated threshold. CONCLUSIONS: Lumbar cages with polyether ether ketone core material failed more frequently by breakage, whereas titanium surface cages failed more frequently by migration. Failure rates varied depending on the manufacturer. Most cage breakages identified in the present study occurred intraoperatively during implantation. These findings call for a more detailed Food and Drug Administration evaluation of these intraoperative malfunctions before commercial approval. LEVEL OF EVIDENCE: Level 4.

Does the Bone Mineral Density of the Lumbar Spine Correlate With Dual-Energy X-ray Absorptiometry T Score? A Cadaveric-Based Analysis of Computed Tomography Densitometry.

BACKGROUND: Pedicle screw loosening is a complication of spinal instrumentation in osteoporotic patients. Dual-energy x-ray absorptiometry scans are not able to detect variations in bone mineral density (BMD) within specific regions of vertebrae. The purpose of this study was to investigate whether spine T scores correlate with cortical and cancellous BMD of pedicles and other 6 anatomical regions of lumbar spine. METHODS: Eleven cadaveric spines with a mean age of 73 years were digitally isolated by applying filters for cortical and cancellous bone on computed tomography images. Eleven L5 vertebrae were separated into 7 anatomical regions of interest using 3-dimensional software modeling. Hounsfield units (HU) were determined for each region and converted to cortical and cancellous BMD with calibration phantoms of known BMD. Correlations between T scores and HU values were calculated using Pearson correlation coefficient. RESULTS: Mean vertebral T score was 0.15. Cortical BMD of pedicles was strongly correlated with T score (R 2 = 0.74). There was moderate correlation between T score and cortical BMD of lamina, inferior articular process (IAP), superior articular process (SAP), spinous process, and vertebral body. There was weak correlation between T score and cortical BMD of transverse process (R 2 = 0.16). Cancellous BMD of vertebral body was strongly correlated with T score (R 2 = 0.82). There was moderate correlation between T score and cancellous BMD of pedicles, spinous process, and transverse process. There was weak correlation between T scores and cancellous BMD of lamina, IAP, and SAP. CONCLUSIONS: There is a strong correlation between T scores and cortical BMD of lumbar pedicle. There is strong correlation between T scores and cancellous BMD of vertebral body. Cortical and cancellous BMD of transverse process and lamina were weakly correlated with T score and less affected by osteoporosis. CLINICAL RELEVANCE: Patients with osteoporosis may especially benefit from the development of extrapedicular fusion strategies due to the relatively higher bone density of these fixation sites.

Fusion Mass Screws in Revision Spinal Deformity Surgery: A Simple and Safe Alternative Fixation.

BACKGROUND: Revision spinal deformity surgery has a high rate of complications. Fixation may be challenging due to altered anatomy. Screws through a fusion mass are an alternative to pedicle screw fixation. OBJECTIVE: The purpose of this retrospective study was to further elucidate the safety and efficacy of fusion mass screws (FMSs) in revision spinal deformity surgery. DESIGN: Retrospective case series. METHODS: Fifteen freehand FMSs were placed in 6 patients with adult spinal deformity between 2016 and 2018 by the senior author. FMSs were combined with pedicle screws, at times at the same level. FMSs were used to save distal levels from fusion, assist in closing a 3-column osteotomy and provide additional fixation in cases of severe instability. Computed tomography (CT) was used to assess bone mineral density (BMD) and thickness of each fusion mass preoperatively along with accuracy of FMS placement postoperatively. RESULTS: The mean BMD of the fusion mass was 397 Hounsfield units (HU; range: 156-628 HU). The mean AP thickness of the fusion mass was 15.5 ± 4.8 mm (range: 8.6-24.4 mm). The mean FMS length was 35.3 ± 5.5 mm (range: 25-40 mm). There was no evidence of FMS loosening, breakage, or pseudarthrosis at latest follow-up (mean: 2.2 years, range: 1.4-3.1 years). No neurologic deficits were observed. 1/15 screws had a low-grade breach into the canal (<2 mm). No patients required revision surgery. CONCLUSION: FMSs may be used to augment fixation in revision spinal deformity cases when pedicle screw placement may be challenging. FMSs may also provide an additional anchor at levels with pedicular fixation.

Validation of a Russian Language Oswestry Disability Index Questionnaire.

Study Design Retrospective reliability and validity study. Objective To validate a recently translated Russian language version of the Oswestry Disability Index (R-ODI) using standardized methods detailed from previous validations in other languages. Methods We included all subjects who were seen in our spine surgery clinic, over the age of 18, and fluent in the Russian language. R-ODI was translated by six bilingual people and combined into a consensus version. R-ODI and visual analog scale (VAS) questionnaires for leg and back pain were distributed to subjects during both their initial and follow-up visits. Test validity, stability, and internal consistency were measured using standardized psychometric methods. Results Ninety-seven subjects participated in the study. No change in the meaning of the questions on R-ODI was noted with translation from English to Russian. There was a significant positive correlation between R-ODI and VAS scores for both the leg and back during both the initial and follow-up visits (p < 0.01 for all). The instrument was shown to have high internal consistency (Cronbach α = 0.82) and moderate test-retest stability (interclass correlation coefficient = 0.70). Conclusions The R-ODI is both valid and reliable for use among the Russian-speaking population in the United States.

Scheuermann kyphosis in nonhuman primates.

STUDY DESIGN: A cadaveric survey of the thoracic spines of extant species of nonbipedal primates for the presence of Scheuermann kyphosis. OBJECTIVE: To determine the presence and prevalence of Scheuermann kyphosis in quadrupedal species of the closest living relatives to humans to demonstrate that bipedalism is not an absolute requirement for the development of Scheuermann kyphosis. SUMMARY OF BACKGROUND DATA: The etiology of Scheuermann kyphosis remains poorly understood. Biomechanical factors associated with upright posture are thought to play a role in the development of the disorder. To date, Scheuermann kyphosis has been described only in humans and extinct species of bipedal hominids. METHODS: Thoracic vertebrae from 92 specimens of Pan troglodytes (chimpanzee) and 105 specimens of Gorilla gorilla (gorilla) from the Hamann-Todd Osteological Collection at the Cleveland Museum of Natural History were examined for Scheuermann kyphosis on the basis of Sorenson criteria and the presence of anterior vertebral body extensions and for the presence of Schmorl nodes. RESULTS: Two specimens of P. troglodytes (2.2%) were found to have anatomic features consistent with Scheuermann kyphosis including vertebral body wedging greater than 5° at 3 or more adjacent levels and the presence of anterior vertebral body extensions. One of the affected specimens (50%) demonstrated the presence of Schmorl nodes whereas 2 of the unaffected specimens (2.2%) had Schmorl nodes. None of the specimens of G. gorilla (0%) were found to have anterior vertebral body extensions characteristic of Scheuermann kyphosis or Schmorl nodes. CONCLUSION: Thoracic kyphotic deformity consistent with Scheuermann kyphosis exists in quadrupedal nonhuman primates. Bipedalism is not a strict requirement for the development of Scheuermann kyphosis, and the evolutionary origins of the disease predate the vertebral adaptations of bipedal locomotion.

Kyphectomy in the treatment of patients with myelomeningocele.

BACKGROUND CONTEXT: Myelomeningocele kyphosis is a complex disorder that usually requires surgical intervention. Many complications can occur as a result of this disorder and its treatment, but only surgical correction offers the possibility of restoring spinal alignment. PURPOSE: The purpose of this retrospective study was to summarize the surgical results, complications, and short-term and midterm outcomes for surgical correction of severe kyphosis using a consistent surgical technique. STUDY DESIGN: This was a retrospective review of our database of pediatric patients with myelomeningocele and lumbar kyphosis who underwent kyphectomy with the use of the Warner and Fackler technique. PATIENT SAMPLE: Eleven pediatric kyphectomy cases performed by a single surgeon from 1984 to 2009 were reviewed. OUTCOME MEASURES: Outcome measures include imaging, kyphotic angle measurement, and physical examination. METHODS: Patients underwent the Warner and Fackler technique of posterior-only kyphectomy and bayonet-shaped anterior sacral fixation. RESULTS: The mean extent of kyphosis was 115.6° (range, 77-176°) preoperatively with a correction to 13.0° (range, 0-32°) postoperatively, and a reduction with an average of 102.6° (range, 65-160°), for an 88.7% correction. On an average, 2.0 (range, 1-6) vertebrae were resected. Immediately postoperatively and at follow-up, with an average of 67.2 months (range, 8-222 months), the average kyphosis angle was 13.0° (range, 0-32°). All patients undergoing the procedure were unable to lie supine preoperatively. All patients postoperatively could lie in the supine position. The functional outcome in patients and caretakers was rated very favorably because all patients and caretakers who provided feedback (9 of 11) reported that they were satisfied with the procedure and would undergo the procedure again if given the choice. CONCLUSIONS: This technique has become the most effective surgical reconstruction in myelomeningocele kyphosis. Although significant complications can occur during and after the procedure, most patients had satisfactory postoperative outcomes and restoration of sagittal balance with high patient and parent satisfaction.

Scoliosis and interspinous decompression with the X-STOP: prospective minimum 1-year outcomes in lumbar spinal stenosis.

BACKGROUND CONTEXT: The X-STOP interspinous decompression device, as a treatment for neurogenic intermittent claudication (NIC) because of lumbar spinal stenosis (LSS), has been shown to be superior to nonoperative control treatment. Current Food and Drug Administration labeling limits X-STOP use to NIC patients with a maximum of 25° concomitant lumbar scoliosis. This value was arrived at arbitrarily by the device developers and is untested. PURPOSE: To determine X-STOP utility for NIC in patients with concomitant lumbar scoliosis. STUDY DESIGN: A prospective, single institution, clinical outcome study comparing patients with scoliosis with patients without scoliosis who underwent X-STOP interspinous decompression for NIC because of LSS. PATIENT SAMPLE: A cohort of 179 consecutive patients, 63 with scoliosis (Cobb angle 11° or more) and 116 without scoliosis, with symptoms attributable to NIC treated between January 2006 and May 2007, were included in the study. OUTCOME MEASURES: All patients completed self-reported preoperative and minimum 1-year postoperative outcome forms. Functional measures included Oswestry Disability Index (ODI), visual analog scale (VAS) pain score, and maximum walking and standing times in minutes. Three questions measured patient satisfaction: How satisfied were you with the procedure (very satisfied, somewhat satisfied, somewhat dissatisfied, or very dissatisfied); Would you have the procedure again? (yes or no); Would you recommend the procedure to a friend? (yes or no). METHODS: Before analysis, the 179 consecutive X-STOP patients were divided into three groups: Group 1 (controls without scoliosis, n=116); Group 2 (low scoliosis: 11-25°, n=41), and Group 3 (high scoliosis: 26° or more, n=22). The three groups were not statistically different for any preoperative functional scores. Groups were analyzed for pre- to postoperative functional change and level of satisfaction. Segmental scoliosis at the treated level was also analyzed. RESULTS: Fifty-six percent of Group 1 and Group 2 patients, but only 18% of Group 3 patients, achieved the success criterion of an ODI improvement of 15 or more points (Group 3 the outlier, p=.004). The satisfaction rate was Group 1, 76%; Group 2, 78%; Group 3, 59% (Group 3 the outlier, p=.0001). On average, all three groups improved for each outcome: Group 1 (ODI 17.3, VAS 2.0, standing time 39 minutes, and walking time 43 minutes), Group 2 (ODI 20.0, VAS 1.9, standing time 65 minutes, and walking time 64 minutes), Group 3 (ODI 7.2, VAS 0.9, standing time 18 minutes, and walking time 16 minutes). There was no statistical relationship between any outcome and segmental scoliosis. CONCLUSIONS: The outcome success rate for the X-STOP procedure to treat NIC is lower in patients with overall lumbar scoliosis more than 25° but is unaltered by segmental scoliosis at the affected level. Although patients and surgeons must be aware that the presence of more than 25° of scoliosis portends less favorable results with X-STOP implantation for NIC because of LSS, success in these patients is not precluded, and selection of treatment must be put into the context of individual patient risk and other treatment options.

Interspinous process decompression with the X-STOP device for lumbar spinal stenosis: a 4-year follow-up study.

X-STOP is the first interspinous process decompression device that was shown to be superior to nonoperative therapy in patients with neurogenic intermittent claudication secondary to spinal stenosis in the multicenter randomized study at 1 and 2 years. We present 4-year follow-up data on the X-STOP patients. Patient records were screened to identify potentially eligible subjects who underwent X-STOP implantation as part of the FDA clinical trial. The inclusion criteria for the trial were age of at least 50 years, leg, buttock, or groin pain with or without back pain relieved during flexion, being able to walk at least 50 feet and sit for at least 50 minutes. The exclusion criteria were fixed motor deficit, cauda equina syndrome, previous lumbar surgery or spondylolisthesis greater than grade I at the affected level. Eighteen X-STOP subjects participated in the study. The average follow-up was 51 months and the average age was 67 years. Twelve patients had the X-STOP implanted at either L3-4 or L4-5 levels. Six patients had the X-STOP implanted at both L3-4 and L4-5 levels. Six patients had a grade I spondylolisthesis. The mean preoperative Oswestry score was 45. The mean postoperative Oswestry score was 15. The mean improvement score was 29. Using a 15-point improvement from baseline Oswestry Disability Index score as a success criterion, 14 out of 18 patients (78%) had successful outcomes. Our results have demonstrated that the success rate in the X-STOP interspinous process decompression group was 78% at an average of 4.2 years postoperatively and are consistent with 2-year results reported by Zucherman et al previously and those reported by Lee et al. Our results suggest that intermediate-term outcomes of X-STOP surgery are stable over time as measured by the Oswestry Disability Index.