[Physical, chemical, and biological property of silk reinforced polycaprolactone composites for bone tissue engineering].

Objective: To develop a biodegradable implantable bone material with compatible mechanics with the bone tissue, providing a new biomaterial for clinical bone repair and regeneration. Methods: Silk reinforced polycaprolactone composites (SPC) containing 20%, 40%, and 60% silk were prepared by layer-by-layer assembly and hot-pressing technology. Macroscopic morphology was observed and microstructure were observed by scanning electron microscopy, compressive mechanical properties were detected by compression test, surface wettability was detected by surface contact angle test, degradation of materials was observed after soaking in PBS for 180 days, and proliferation of MC3T3-E1 cells was detected by cell counting kit 8 assay. Six Sprague Dawley rats were subcutaneously implanted with polycaprolactone (PCL) and 20%-SPC, respectively. Masson staining was used to analyze the in vivo degradation behavior and vascularization effect within 180 days. Results: The pore defects of the three SPC sections were relatively few. In the range of 20% to 60%, as the silk content increased and the PCL content decreased, the interlayer spacing of silk fabric decreased, and the fibers almost covered the entire cross-section. The compressive modulus and compressive strength of SPC showed an increasing trend, and the compressive modulus of 60%-SPC was slightly lower than that of 40%-SPC. There were significant differences in compressive modulus and compressive strength between the materials ( P<0.05). In vitro simulated fluid degradation experiments showed that the mass loss of the three types of SPC after 180 days of degradation was within 5%, with the highest mass loss observed in 60%-SPC. The differences in mass loss between the materials were significant ( P<0.05). As the silk content increased, the static water contact angle of each material gradually decreased, and all could promote the proliferation of MC3T3-E1 cells. The subcutaneous degradation experiment in rats showed that 20%-SPC began to degrade at 30 days after implantation, and material degradation and vascularization were significant at 180 days, which was in sharp contrast to PCL. Conclusion: SPC has the mechanical and hydrophilic properties that are compatible with bone tissue. It maintains its mechanical strength for a long time in a simulated body fluid environment in vitro, and achieves dynamic synchronization of material degradation, tissue regeneration, and vascularization through the body's immune regulation mechanism in vivo. It is expected to provide a new type of implant material for clinical bone repair.

Safety and efficacy of intrawound vancomycin powder in the prevention of lumbar surgical site infection: A prospective, double-blind, randomized controlled study.

BACKGROUND: To evaluate the safety and efficacy of intra-wound vancomycin powder in reducing surgical site infections (SSIs) after spine surgery. DESIGN: A prospective, double-blind, randomized controlled study. PARTICIPANTS: Patients who underwent posterior lumbar interbody fusion (PLIF) surgery from May 2021 to September 2022. METHODS: Patients who underwent posterior lumbar interbody fusion (PLIF) surgery between May 2021 and September 2022 were included. Participants were randomized to the vancomycin treatment or control groups using block randomization (block size 4). Except for baseline and surgical data, the plasma levels of white blood cells, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), aspartate aminotransferase, alanine aminotransferase, and serum vancomycin concentration in the groups were analyzed on postoperative days (PODs) 1, 3, and 5. Vancomycin concentration was measured daily until the drainage tubes were removed. The primary outcomes were the 90-day vancomycin-related adverse reactions and SSI rates. Secondary outcomes were perioperative hematological parameters and vancomycin serum (drain) concentrations. RESULTS: A total of 156 participants (78 each in each group) were analyzed by an independent researcher. The follow-up rate was 91%. All participants were followed up for at least 90 days. The 90-day SSI rate in the vancomycin group was 1.3% (1/78), comprising one case of superficial infection. The SSI rate in the control group was 10.3% (8/78), comprising seven cases of superficial infection and one case of deep infection. Compared with that in the control group, the SSI rate in the vancomycin group was decreased by 87.5%, with a statistically significant difference (RR=0.125, 95% CI=0.016-0.976). Additionally, the vancomycin group demonstrated a statistically significant decrease in serum ESR on POD 3 (P=0.039) and CRP on POD 5 (P=0.024) compared to the control group. The local plasma concentration of vancomycin remained elevated for at least 4 days postoperatively, while the serum concentration of vancomycin remined low. Vancomycin-associated adverse reactions were not observed. CONCLUSION: Intra-wound application of vancomycin powder is a safe and effective procedure for reducing the risk of SSI during PLIF surgery.

Percutaneous endoscopic transforaminal discectomy and unilateral biportal endoscopic discectomy for lumbar disc herniation: a comparative analysis of learning curves.

OBJECTIVE: The purpose of this study was to investigate the learning curve of percutaneous endoscopic transforaminal discectomy (PETD) and interlaminar unilateral biportal endoscopic discectomy (UBED) in the treatment of lumbar disc herniation (LDH). METHODS: Between 2018 and 2023, 120 consecutive patients with lumbar disc herniation (LDH) treated by endoscopic lumbar discectomy were retrospectively included. The PETD group comprised 87 cases, and the UBED group comprised 33 cases. Cumulative sum analysis was used to evaluate the learning curve, with the occurrence of complications or unresolved symptoms defined as surgical failure, and variables of different phases of the learning curve being compared. RESULTS: The learning curve analysis identified the cutoff point at 40 cases in the PETD group and 15 cases in the UBED group. In the mastery phase, both PETD and UBED demonstrated a significant reduction in operation times (approximately 38 min for PTED and 49 min for UBED). In both PETD and UBED groups, the surgical failure rates during the learning and mastery phases showed no statistically significant differences. The visual analogue scale at the last follow-up was significantly lower than before surgery in both the PETD and UBED groups. CONCLUSION: PETD and UBED surgery are effective in the treatment of LDH with a low incidence of complications. However, achieving mastery in PETD necessitates a learning curve of 40 cases, while UBED requires a minimum of 15 cases to reach proficiency.

Low profile posterior lumbar-sacral interbody fusion for lumbosacral degenerative diseases: a technical note.

BACKGROUND: The purpose of this study was to report our surgical experience in patients with lumbosacral degenerative diseases who underwent posterior decompression and interbody fusion fixed with cortical bone trajectory screw and sacral alar screw, which is known as low-profile posterior lumbosacral interbody fusion (LP-PLSIF). METHODS: Patients with lumbosacral degenerative disease who underwent LP-PLSIF and traditional PLSIF (control group) internally fixed with pedicle screws were included retrospectively. Patients' demographic data, operative parameters, and perioperative complications were recorded and analyzed. RESULTS: A total of 18 patients were enrolled in this study, which included 9 patients (5 male and 4 female) who underwent LP-PLSIF, and 9 patients (4 male and 5 female) who underwent traditional PLSIF. There wasn't a significant difference in the average age between the two groups, 56.78 ± 10.92 years in the LP-PLSIF group and 60.22 ± 8.21 years in the PLSIF group (p = 0.460). The bone mineral density (BMD) of the two groups of patients were -2.00 ± 0.26 T and -2.13 ± 0.19 T, respectively (P = 0.239). The mean postoperative follow-up time was 12.7 months (range, 12-14 months). The mean operation time was 142.78 ± 11.21 min and 156.11 ± 13.41 min in the LP-PLSIF group and PLSIF group respectively (P < 0.05). The average blood loss was 137.78 ± 37.09 ml in the LP-PLSIF group, and 150.00 ± 27.84 ml in the PLSIF group (P = 0.441). The average postoperative drainage was 85.56 ± 37.45 ml and 122.22 ± 22.24 ml in the LP-PLSIF group and control group respectively (P < 0.05). Patients in the LP-PLSIF group had shorter incision length compared with the control group, 61.44 ± 10.56 mm vs. 74.56 ± 10.22 mm (P < 0.05). The average length of hospitalization of 11.33 ± 2.92 days in the LP-PLSIF group, and 11.11 ± 1.62 days in the PLSIF group (p = 0.844). All patients had significant improvement in VAS pain score, ODI, and JOA evaluation. However, patients in the LP-PLSIF group had better improvement in terms of VAS back pain and ODI in the short term after the operation. There were no neurological complications or wound infection. The fusion rate at the last follow-up was 100% (9 of 9) in the LP-PLSIF group, and 88.89% (8 of 9) in the control group based on CT scans. 1 patient in the control group had asymptomatic sacral pedicle screw loosening. CONCLUSIONS: LP-PLSIF is a safe and effective surgical technique for patients with lumbosacral degenerative disease, which has the potential strength of less invasive and better clinical improvement.

The accuracy of cortical bone trajectory screw placement guided by spinous process clamp hardware in lumbar spinal surgery: a retrospective study.

This study aimed to assess the accuracy of cortical bone trajectory (CBT) screws placement guided by a spinous process clamp (SPC) guide. A total of 32 patients who received single-level midline lumbar fusion (MIDLF) surgery between June 2019 and January 2020 were retrospectively analyzed and divided into free-hand (FH) and SPC-guided groups according to the surgical approach. In the FH group, CBT screws was implanted with the assistance of fluoroscopy, while in the SPC group, CBT screws was implanted using the SPC navigator hardwire. A total of 128 screws were assessed in this study, with higher rates of clinically acceptable screw placement (grades A and B) and grade A screws in the SPC group than in the FH guide group (92.2% vs. 79.7%, P = 0.042 and 54.7% vs. 35.9%, P = 0.033, respectively). Misplacement screws (grades C, D, and E) occurred more often in the FH group than in the SPC guide group (20.3% vs. 7.8%, P = 0.042). The incidence of proximal facet joint violation (FJV) was higher in the FH group than in the SPC group (15.6% vs. 3.1%, P = 0.030). The radiation dose and time in the SPC guide group were comparable to those in the FH group (P = 0.063 and P = 0.078). The average operative time was significantly longer in the SPC guide group than in the FH group (267.8 ± 45.5 min vs. 210.9 ± 44.5 min, P = 0.001). Other clinical parameters, such as the average bone mineral density (BMD), intraoperative blood loss, and postoperative hospital stay, were not significantly different. Oswestry disability index (ODI) and back pain visual analogue scale (VAS) scores were significantly improved in both groups compared with preoperatively. SPC guided screw placement was more accurate than the fluoroscopy-assisted FH technique for single-level MIDLF at L4/5. Patients undergoing SPC-guided screw placement can achieve similar clinical outcomes as the fluoroscopy-assisted FH technique.

Postoperative complications following Schwab-grade-I versus Schwab-grade-II PCO in treating severe rigid kyphoscoliosis patients: comparative matched-group outcomes with minimum 2-year follow-up.

BACKGROUND CONTEXT: Standard partial facetectomies, (Smith-Petersen Osteotomy, (SPO), (Schwab-grade-I) and complete facet resection also known as Ponte osteotomy, (PO), (Schwab-grade-II) are narrowly akin and collectively appreciated as posterior column shortening osteotomies (PCOs). The former is considered a gentler osteotomy grade than the latter. The spine literature provides very little information on their comparison regarding perioperative complications and major curve correction rate outcomes. PURPOSE: To determine whether Schwab-grade-I PCO (SPO) and Schwab-grade-II PCO (PO) are comparably safe in the surgical management of severe rigid scoliosis or kyphoscoliosis patients. STUDY DESIGN/SETTING: Retrospective single-center comparative clinical study. PATIENT SAMPLE: A total of 38 patients with severe rigid scoliosis or kyphoscoliosis were propensity score matched in this study, (SPO-treated); n=21 (55.30%) and (PO-treated); n=17 (44.70%), who underwent primary spinal deformity corrective surgery, respectively. OUTCOME MEASURES: Outcomes included demographics, baseline pulmonary functional outcomes, perioperative complications incidence, hospital costs, Oswestry disability index (ODI), and the Scoliosis Research Society-22 (SRS-22) questionnaire scores. METHODS: Following approval by the Institutional Review Board (IRB) of Beijing Chaoyang Hospital-Affiliated Capital Medical University in Beijing, out of a total of 82 consecutive surgical patients with complete data demonstrating severe and/or rigid spinal deformity, a pool of 38 of the 82 (46.3%) propensity-matched adult (≥18 years) patients with severe rigid scoliosis or kyphoscoliosis defined with a preoperative major curve magnitude of ≥80° on anteroposterior plain radiographs, and flexibility of <25% on bending plain radiographs who underwent primary spinal deformity corrective surgery were retrospectively evaluated. The patients were dichotomized into two osteotomy groups: standard (partial) facetectomy (SPO-treated), n=21 with an average age of 24.67 years, (Schwab-grade-I PCO) and complete facet excision, (PO-treated), (ie, Schwab-grade-II PCO), n=17 with an average age of 23.12 years. The minimum follow-up period was 2 years. Primary outcomes included baseline demographics and clinical features. Secondary outcomes included perioperative [intraoperative, immediate, and 2-year postoperative] complication rates. Tertiary outcomes included perioperative ODI and SRS-22 scores. Statistical analyses were carried out by Student t-test and Pearson's Chi-square test (Fisher's Exact Test), through Python statistical software package. Statistical significance was set at (p<.05). RESULTS: Of the 38 matched severe rigid scoliosis or kyphoscoliosis patients, 55.30% (n=21) were SPO-treated and 44.70% (n=17) were PO-treated patients, respectively. The overall average age of patients was 23.97 years, with a female incidence of 76.32%. Major curve correction rates were 49.19% and 57.40% in SPO-treated and PO-treated patients, respectively, (p>.05). Immediately following surgery, comparable overall complication rates of 28.57% (n=6/21) versus 29.41% (n=5/17) were observed in the SPO-treated and PO-treated patients, respectively, (p=.726). We observed incidences of 9.52%, (n=2/21) versus 5.88%, (n=1/17) for surgical intensive care unit (SICU) admission, and incidences of 4.76%, (n=1/21) versus 5.88%, (n=1/17) for cardiopulmonary events in SPO-treated versus PO-treated patients following corrective surgery, respectively, (p>.05). The incidences of neurological deficits in the SPO-treated and PO-treated patients were respectively, 14.29%, (n=3/21) versus 17.65%, (n=3/17) immediately following surgery, (p>.05), and 0.00%, (n=0/21) in SPO-treated versus 14.28%, (n=3/21) in PO-treated patients at ≥2 years postoperative, (p<.05). Among the three patients that reported neurological deficits in the PO-treated group at ≥2 years postoperative, two patients had pre-existing baseline neurological deficits. The ODI score in the PO-treated group was significantly inferior at a minimum 2-year follow-up, (p<.05). CONCLUSIONS: In the current study, both SPO-treated and PO-treated patients demonstrated statistically comparable surgical complications immediately following corrective surgery. Severe rigid kyphoscoliosis patients with preexisting baseline neurological deficits were more inclined to sustain neurological morbidity following corrective surgery. PCO corrective techniques are warranted as safe options for treating patients with severe rigid spine deformity phenotypes.

Comparison of complications, revisions, spinopelvic parameters, and health-related quality of life after posterior spinal fusion using multiple-rod constructs or two-rod constructs for adult spinal deformity: a systematic review and meta-analysis.

BACKGROUND: The incidence of mechanical complications is high in patients undergoing posterior spinal fusion (PSF) for adult spinal deformity (ASD), especially for cases with severe sagittal malalignment or a prior spinal fusion requiring three-column osteotomy (3-CO) or spinopelvic fixation (SPF). The purpose of this systematic review and meta-analysis was to compare the complications, revisions, radiographic spinopelvic parameters, health-related quality of life (HRQoL), and surgical data of PSF using multiple-rod constructs to those of two-rod constructs for the treatment of ASD. METHODS: A comprehensive literature search was performed for relevant studies in PubMed, EMBASE, Web of Science, and the Cochrane Library. Complications, revisions, spinopelvic parameters, HRQoL, and surgical date were compared between patients with ASD who underwent PSF using multiple-rod constructs (multi-rod group) and two-rod constructs (two-rod group). RESULTS: Ten studies, comprising 797 patients with ASD (399 in the multi-rod group and 398 in the two-rod group), were included. All these studies were retrospective cohort studies. There were no significant differences in the surgical, wound-related, and systemic complications between the groups. In the multi-rod group, we noted a significantly lower incidence of rod fracture (RR, 0.43; 95% CI 0.33 to 0.57, P < 0.01), pseudoarthrosis (RR, 0.38; 95% CI 0.28 to 0.53, P < 0.01), and revisions (RR, 0.44; 95% CI 0.33 to 0.58, P < 0.01); a superior restoration of PI-LL (WMD, 3.96; 95% CI 1.03 to 6.88, P < 0.01) and SVA (WMD, 31.53; 95% CI 21.16 to 41.90, P < 0.01); a better improvement of ODI score (WMD, 6.82; 95% CI 2.33 to 11.31, P < 0.01), SRS-22 total score (WMD, 0.44; 95% CI 0.06 to 0.83, P = 0.02), and VAS-BP score (WMD, 1.02; 95% CI 0.31 to 1.73, P < 0.01). CONCLUSION: Compared with the two-rod constructs, PSF using multiple-rod constructs was associated with a lower incidence of mechanical complications, a lower revision rate, a superior restoration of sagittal alignment, and a better improvement of HRQoL, without increasing surgical invasiveness. Multiple-rod constructs should be routinely considered to for ASD patients, especially for cases with severe sagittal malalignment or a prior spinal fusion requiring 3-CO or SPF.

Clinical Application of Personalized Digital Surgical Planning and Precise Execution for Severe and Complex Adult Spinal Deformity Correction Utilizing 3D Printing Techniques.

(1) Background: The three-dimensional printing (3DP) technique has been reported to be of great utility in spine surgery. The purpose of this study is to report the clinical application of personalized preoperative digital planning and a 3DP guidance template in the treatment of severe and complex adult spinal deformity. (2) Methods: eight adult patients with severe rigid kyphoscoliosis were given personalized surgical simulation based on the preoperative radiological data. Guidance templates for screw insertion and osteotomy were designed and manufactured according to the planning protocol and used during the correction surgery. The perioperative, and radiological parameters and complications, including surgery duration, estimated blood loss, pre- and post-operative cobb angle, trunk balance, and precision of osteotomy operation with screw implantation were collected retrospectively and analyzed to evaluate the clinical efficacy and safety of this technique. (3) Results: Of the eight patients, the primary pathology of scoliosis included two adult idiopathic scoliosis (ADIS), four congenital scoliosis (CS), one ankylosing spondylitis (AS), and one tuberculosis (TB). Two patients had a previous history of spinal surgery. Three pedicle subtraction osteotomies (PSOs) and five vertebral column resection (VCR) osteotomies were successfully performed with the application of the guide templates. The main cobb angle was corrected from 99.33° to 34.17°, and the kyphosis was corrected from 110.00° to 42.00°. The ratio of osteotomy execution and simulation was 97.02%. In the cohort, the average screw accuracy was 93.04%. (4) Conclusions: The clinical application of personalized digital surgical planning and precise execution via 3D printing guidance templates in the treatment of severe adult rigid deformity is feasible, effective, and easily generalizable. The preoperative osteotomy simulation was executed with high precision, utilizing personalized designed guidance templates. This technique can be used to reduce the surgical risk and difficulty of screw placement and high-level osteotomy.

Long-Term Radiographic and Pulmonary Function Outcomes After Dual Growing-Rod Treatment for Severe Early-Onset Scoliosis.

BACKGROUND: We evaluated long-term outcomes (radiographic parameters and pulmonary function) at a minimum follow-up of 5 years after use of dual growing rods (DGRs) to treat severe early-onset scoliosis (sEOS). METHODS: Among a total of 112 patients who were diagnosed with early-onset scoliosis (EOS) and were treated with DGRs between 2006 and 2015, 52 patients had sEOS, with a major Cobb angle of >80°. Of these patients, 39 with a minimum follow-up of 5 years had complete radiographic and pulmonary function test results and were included. The Cobb angle of the major curve, T1-S1 height, T1-T12 height, and maximum kyphosis angle in the sagittal plane were measured on radiographs. Pulmonary function test results were collected in all patients before the initial operation (preoperatively), 12 months after the initial operation (postoperatively), and at the last follow-up. The changes in pulmonary function and complications during treatment were analyzed. RESULTS: The mean age of patients before the initial operation was 7.7 ± 1.2 years, and the mean follow-up period was 75.0 ± 14.1 months. The mean number of lengthenings was 4.5 ± 1.3, and the mean interval between lengthenings was 11.2 ± 2.1 months. The Cobb angle improved from 104.5° ± 18.2° preoperatively to 38.1° ± 10.1° after the initial surgical procedure (postoperatively) and 21.9° ± 8.6° at the final follow-up. The T1-S1 height increased from 25.1 ± 4.0 cm preoperatively to 32.4 ± 3.5 cm postoperatively and to 39.5 ± 4.0 cm at the final follow-up. However, no significant difference was detected between the increased pulmonary function parameters at 1 year and those before the operation (p > 0.05), except for residual volume, whereas pulmonary function parameters had significantly increased at the final follow-up (p < 0.05). During the treatment period, 17 complications occurred in 12 patients. CONCLUSIONS: DGRs are effective in treating sEOS in the long term. They allow longitudinal growth of the spine, and the correction of the spinal deformity can provide conditions that make improving pulmonary function possible in patients with sEOS. LEVEL OF EVIDENCE: Therapeutic Level IV . See Instructions for Authors for a complete description of levels of evidence.

Distal foundation augmentation enhances the "Bridge" role of single traditional growing rods in the treatment of severe early-onset scoliosis: a retrospective comparative cohort study.

Background: Dual traditional growing rod (dTGR) implantation may not always be feasible for patients with severe early-onset scoliosis (EOS). The concave single traditional growing rod (sTGR) can serve as a starting construct. Distal foundation augmentation (DFA) with four pedicle screws with a cross-link can increase the spinal control provided by a dTGR. However, DFA has yet to be used with a sTGR. This study investigated the efficiency of DFA in patients with severe EOS who underwent sTGR implantation. Methods: From 2010 to 2021, 74 consecutive patients with severe EOS (major curve ≥80°) who underwent traditional growing rod implantation (48 sTGR and 26 dTGR) with a minimum 24-month follow-up were recruited. The sTGR cohort was further divided into two groups by whether or not DFA was performed. In our center, patients who were admitted for sTGR implantation after 2018 routinely underwent DFA. The implantation of a dTGR was based on the severity of thoracic torsion and BMI. Baseline clinical characteristics, complications, and radiographic parameters preoperatively, postoperatively, and at the last follow-up before conversion to a dual rod instrumentation were compared between the three groups. Results: There was no significant difference in baseline clinical characteristics between the three groups (P>0.05). Twenty-four patients in the sTGR cohort underwent DFA. There was no significant difference in preoperative radiographic parameters between the DFA and non-DFA group (P>0.05). Compared with the non-DFA group, the DFA group had superior results at the last follow-up in terms of maintaining the correction of the major curve (P=0.001), maximal kyphosis correction (P=0.001), the distance between the C7 plumb line and the central sacral vertical line (P=0.036), and distracting the growing thorax (P=0.032) and trunk (P=0.044). Furthermore, the incidence of implant-related complications (P=0.019), especially at the distal foundation (P=0.033), was significantly lower in the DFA group. There was no significant difference between the DFA and dTGR groups in radiographic outcomes or complications at the final follow-up (P>0.05). Conclusions: For patients with severe EOS who undergo sTGR implantation, DFA might better maintain the deformity correction, distract the growing spine, preserve balance, and decrease the incidence of implant-related complications. The efficiency of sTGR with DFA was comparable to that of the gold-standard dTGR treatment. Further multicenter randomized controlled trials are needed for more convincing conclusions.