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Background: The most frequently occurring adverse events in individuals with a transfemoral amputation treated with a bone-anchored prosthesis are soft tissue infections and stoma-related complications. These soft tissue complications are believed to be influenced by surgical technique and implant design, but little is known about the effect of changes to treatment on these events. Questions/purposes: (1) What is the result of surgical technique and implant modifications on the incidence of soft tissue infections and stoma-related complications in transfemoral bone-anchored prosthesis users, depending on whether they had a conventional stoma and a cobalt-chrome-molybdenum (CoCrMo) osseointegration implant (treatment period 2009 to 2013) or a shallower stoma and titanium osseointegration implant (2015 to 2018)? (2) What is the incidence of serious complications, such as bone or implant infection, aseptic loosening, intramedullary stem breakage, and periprosthetic fracture? Methods: Between 2009 and 2013, we performed osseointegration implant surgery using a conventional surgical technique and a CoCrMo implant in 42 individuals who had a lower extremity amputation experiencing socket-related problems that resulted in limited prosthesis use. We considered all individuals treated with two-stage surgery with a standard press-fit transfemoral osseointegration implant as potentially eligible for inclusion. Based on this, 100% (42) were eligible, and 5% (two of 42) were excluded because they did not provide informed consent, leaving 95% (40 of 42) for analysis. Between 2015 and 2018, we treated 79 individuals with similar indications with osseointegration implant surgery, now also treating individuals with dysvascular amputations. We used an adapted surgical technique resulting in a shallower stoma combined with a titanium implant. Using the same eligibility criteria as for the first group, 51% (40 of 79) were eligible; 49% (39 of 79) were excluded because they were treated with transtibial amputation, a patient-specific implant, or single-stage surgery and 1% (one of 79) were lost before the 2-year follow-up interval, leaving 49% (39 of 79) for analysis. The period of 2013 to 2015 was a transitional period and was excluded from analysis in this study to keep groups reasonably comparable and to compare a historical approach with the present approach. Hence, we presented a comparative study of two study groups (defined by surgical technique and implant design) with standardized 2-year follow-up. The risk factors for adverse events were similar between groups, although individuals treated with the shallow stoma surgical technique and titanium implant potentially possessed an increased risk because of the inclusion of individuals with dysvascular amputation and the discontinuation of prolonged postoperative antibiotic prophylaxis. Outcomes studied were soft tissue infections and stoma-related complications (hypergranulation or keloid formation as well as stoma redundant tissue) and bone or implant infection, aseptic loosening, implant stem breakage, periprosthetic fracture, and death. Results: Patients treated with the shallow stoma surgical technique and titanium implant experienced fewer soft tissue infections (13 versus 76 events, absolute risk 0.17 [95% CI 0.09 to 0.30] versus 0.93 [95% CI 0.60 to 1.45]; p < 0.01), which were treated with less invasive measures, and fewer stoma redundant tissue events (0 versus five events, absolute risk 0 versus 0.06 [95% CI 0.03 to 0.14]) than patients treated with the conventional stoma surgical technique and CoCrMo implant. This was contrasted by an increased incidence of surgical site infections occurring between surgical stages 1 and 2, when no stoma was yet created, after the implementation of treatment changes (conventional surgery and CoCrMo implant versus shallow stoma surgery and titanium implant: one versus 11 events, absolute risk 0.01 [95% CI 0.00 to 0.08] versus 0.14 [95% CI 0.08 to 0.25]; p = 0.02). Patients treated with the shallow stoma surgical technique and titanium implant did not experience serious complications, although bone infections occurred (six events in 8% [three of 40] of patients) in the conventional surgery and CoCrMo implant group, all of which were successfully treated with implant retention. Conclusion: Adaptations to surgical technique and newer implant designs, as well as learning curve and experience, have resulted in a reduced incidence and severity of soft tissue infections and stoma redundant tissue, contrasted by an increase in surgical site infections before stoma creation. Serious complications such as deep implant infection were infrequent in this 2-year follow-up period. We believe the benefits of these treatment modifications outweigh the disadvantages and currently advise surgeons to create a shallower stoma with a stable soft tissue envelope, combined with a titanium implant. Level of Evidence: Level III, therapeutic study. [ABSTRACT FROM AUTHOR]

Background: Conventional surgical treatment for adolescent idiopathic scoliosis (AIS) consists of correction of the spinal deformity with rigid spinal instrumentation and fusion. Less-invasive and fusionless surgery could potentially improve patient outcomes. The purpose of the present study was to evaluate the efficacy of a recently U.S. Food and Drug Administration (FDA)-approved posterior peri-apical self-distracting device (ApiFix) that is designed to gradually correct the deformity without spinal fusion.Methods: In a prospective cohort study of 20 patients with AIS (Risser stage 1-4; Lenke 1 or 5; major curve Cobb angle, 40° to 55°; and Bunnell scoliometer rotation, <15°) were managed with the ApiFix device. Clinical and radiographic performance was assessed.Results: Twenty patients with a mean age (and standard deviation) of 14.8 ± 1.4 years were followed for a mean of 3.4 ± 1.0 years. The average major curve was reduced from 45.4° preoperatively to 31.4° at 2 weeks postoperatively and 31.0° at the time of the latest follow-up. The average minor curve measured 31.3° preoperatively, 26.1° at 2 weeks postoperatively, and 24.2° at the time of the latest follow-up. Ten patients had serious complications that required revision surgery, including osteolysis (n = 6), screw and/or rod breakage (n = 2), failure of the ratchet mechanism (n = 1), and pain without explainable cause (n = 1). During revision surgery, metallosis was observed in all patients and cultures showed growth of Cutibacterium acnes in 6 patients. Because of the high failure rate, the study was terminated early.Conclusions: The use of the unilateral peri-apical concave self-distracting ratchet rod initially was associated with promising clinical and radiographic results. However, no distraction was observed and the high rate of serious adverse events within 2 years was considered to be unacceptable for further clinical application of this device in our institution, despite recent FDA approval.Level Of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]

Nonoperative management of juvenile idiopathic scoliosis (JIS) has been reported to be less effective than that of infantile idiopathic scoliosis. The goal of this study was to analyse the results of casting and/or bracing in JIS. Clinical data from seven patients with JIS, treated with casting followed by bracing (n=3) or by bracing alone (n=4), were retrospectively collected, and curve severity was measured before, during and after treatment. The median Cobb angle decreased from 37° to 25°. No patient needed surgery at a median follow-up of 4.6 years (3.4-9.1 years). Casting and/or bracing is effective for the management of JIS.

Study Design: In this study, 330 patients with incapacitating low back pain underwent temporary external transpedicular fixation (TETF) of the lumbosacral spine in a prospective trial., Objective: To evaluate TETF as a test for selecting suitable candidates for segmental spinal fusion., Summary of Background Data: Few studies regarding TETF have been published, and contradictory results concerning predictive value and morbidity were reported., Methods: All patients were tested with the external fixator in two different positions: fixation and nonfixation. Before and during the test and at follow-up examination, pain was assessed on a Visual Analogue Scale (VAS). The TETF test was considered to be positive if the VAS score in the fixation state was 30 or more points lower than in the nonfixation state. Hence, a positive test would imply the decision to perform segmental lumbosacral fusion. When the reduction was less than 30 points, the test was negative. Individual pain reduction and working capacity were taken as measure of outcome., Results: Most of the patients in this study (62%) underwent spinal surgery previously. The positive and negative TETF groups were quite similar, but a large within-group variation was found. Within the fusion group of 123 patients, improvement in VAS scores and improvement in working capacity were not significantly better for the positive TETF group in comparison with the negative TETF group., Conclusion: In this heterogeneous group of chronic patients with low back pain, TETF of the spine (including a placebo trial) does not appear to be of value in selecting suitable candidates for spinal fusion.

Study Design: A historic cohort to determine short-term complications after 115 corrective osteotomies of the cervical and lumbar spine in patients with ankylosing spondylitis., Objectives: To describe the nature of complications of spinal osteotomies and sequelae., Summary of Background Data: Little is known about the rate and nature of complications after spinal osteotomy in these patients., Methods: A chart review of 106 patients (age, 21-82 years) was conducted. The following surgical techniques were performed: cervical-thoracic extending osteotomy at C6-Th1 (n = 22), lumbar closing-wedge osteotomy (n = 62), polysegmental lumbar osteotomy (n = 20), or a combined anterior-posterior lumbar correction (n = 11)., Results: Many complications (7.8% permanent neurologic deficit, 9.6% deep wound infections, and 10.4% major general complications) occurred after performing a spinal correction. Since 1998, there is a tendency for a lower rate of infections but a higher rate of neurologic and major general complications. Because of 27% deep wound infections and 18% major general complications, the technique of combined anterior and posterior surgery has been abandoned., Conclusion: High complication rates in this group of patients are partly due to the difficult surgery but also to the underlying disease. The surgery should be concentrated in specialized centers.

Study Design: Fifty-two patients with degenerative disc disease underwent single- or double-level anterior lumbar interbody fusion with SynCage and additional posterior fixation as treatment for degenerative disc disease and were prospectively followed for 4 years., Objectives: To test the clinical performance of anterior lumbar interbody fusion with SynCage, with emphasis on the safety and efficacy of the surgical procedure and the ability to restore anatomy and fuse the motion segment., Summary of Background Data: Anterior lumbar interbody fusion using femoral allograft and/or autologous bone has a high complication rate. With cage technology, some of these complications can be avoided. The design characteristics of the SynCage offer advantages in restoring and maintaining intervertebral height and restoration of lumbar lordosis., Methods: Thirty-three patients underwent single-level and 19 patients double-level anterior lumbar interbody fusion with SynCage and additional posterior fixation (translaminar screws, n = 32 or pedicle screws, n = 10). Radiologic and functional results (VAS and Oswestry score) were evaluated., Results: Intervertebral height was corrected from an average of 8.7 to 17.6 mm. Lordosis of the fused segment was significantly increased (average 10.6 degrees for the fused segment and 8 degrees for lumbosacral lordosis). After 2 years, there was radiologic evidence for fusion in 70 of 71 (98.6%) levels. Functional scores showed a significant improvement in pain and function up to the 2-year follow-up observation. At the 4-year follow-up observation, there was some loss of the initial improvement in VAS and Oswestry scores. Despite this loss, they remained significantly better than the preoperative scores., Conclusions: Anterior lumbar interbody fusion with SynCage and additional posterior fixation is a safe and effective procedure. Intervertebral height is corrected, and lumbosacral lordosis is restored. An initial improvement in VAS and Oswestry scores is partly lost at the 4-year follow-up observation, but 4-year results are still significantly better than the preoperative scores.

Study Design: A historic cohort study of the sagittal alignment in 33 consecutive patients with surgically corrected thoracic Scheuermann kyphosis., Objectives: To determine if postsurgical imbalance, sagittal malalignment, and decreased lumbar-pelvic range of motion in patients with thoracic Scheuermann kyphosis is related to tight hamstrings., Summary of Background Data: Tight hamstrings are a frequent sign in Scheuermann kyphosis. The importance of tight hamstrings in the surgical management of Scheuermann kyphosis has not yet been studied., Methods: Thirty-three patients with Scheuermann kyphosis were managed by surgical correction and fusion. Tight hamstrings, lumbar-pelvic range of motion, and sagittal balance were evaluated. Sixteen patients had tight hamstrings, and 17 patients had nontight hamstrings. Hamstrings were considered tight if the popliteal angle was >30 degrees., Results: Patients with tight hamstrings have a significantly greater risk of postoperative imbalance (P = 0.05), and these patients can only compensate for this risk by reducing their lumbar lordosis (P = 0.0227). Furthermore, the limitations in the lumbar and pelvic range of motion are predicted by tight hamstrings (P

Study Design: A descriptive historic cohort study was conducted., Objectives: To determine intraoperative response amplitude criteria for transcranial electrical motor-evoked potential monitoring that warn of neurologic damage, and to determine the additional value of monitoring six instead of two muscle sites., Summary of Background Data: Transcranial electrical motor-evoked potential monitoring provides immediate and reliable information about the integrity of the motor pathways during spine surgery. Although this monitoring technique is more frequently used, criteria for interpretation of the amplitude responses have not been defined., Methods: The intraoperative monitoring outcomes were compared with the patient's clinical outcomes. The sensitivity, specificity, positive predictive value, and negative predictive value were determined for four different monitoring criteria., Results: Transcranial electrical motor-evoked potential monitoring was possible 142 of 145 patients undergoing corrective surgery. In this study, 16 patients had a neurologic event, and 11 patients showed recovery of response amplitude after a second surgical maneuver, whereas the remaining 5 patients had permanent partial neurologic damage. The criterion that at least one of six recordings must show an amplitude decrease of more than 80% was sufficiently strict to achieve a sensitivity of 1.0 and a specificity of 0.91. Less strict criteria, including recording at two instead of six sites, resulted in lower sensitivity, with the lower bound of the 95% confidence interval at 0.62., Conclusions: Transcranial electrical motor-evoked potential monitoring allowed successful intraoperative monitoring. The criterion of one recording showing a response amplitude decrease of more than 80% during a surgical action can be considered a valuable warning criterion for neurologic damage. The authors also consider that monitoring at six instead of two muscles improves the value of neuromonitoring.

Study Design: A historic cohort study was conducted to investigate surgical correction and sagittal alignment in 33 patients with thoracic Scheuermann's disease., Objective: To evaluate kyphosis correction, correction loss, sagittal balance, and the effect of an anterior release., Summary of Background Data: Currently, both posterior and anteroposterior techniques seem to produce impressive corrections for Scheuermann's disease. However, few reports have been made on sagittal malalignment after surgery., Methods: A cohort of 33 patients who had undergone surgery for their Scheuermann's kyphosis were reviewed: Group A: posterior technique (n = 16), Group B: anteroposterior technique (n = 17). Pre- and postoperative curve morphometry (Cobb, Ferguson, Voutsinas), balance (C7 plumb line), and Oswestry score were compared., Results: The mean follow-up period was 4.5 +/- 2 years (range, 2-8.2 years). The mean preoperative kyphosis (Cobb) was 78.7 degrees +/- 8.9 degrees, and the mean postoperative kyphosis was 51.7 degrees +/- 10.3 degrees. At follow-up evaluation, the correction loss was 1,4 degrees +/- 3.9 degrees. There was no difference in curve morphometry, correction, sagittal balance, average age, and follow-up period between Groups A and B. One junctional kyphosis, in Group B, was noted. After surgery, all the patients were satisfied, and the Oswestry score showed significant improvement. No neurologic complications were observed., Conclusions: Good follow-up results included a 100% follow-up rate, adequate corrections, little correction loss, lower Oswestry scores, and a high satisfaction rate in both groups. The anteroposterior treatment did not influence the curve morphometry more than posterior fusion only. In reducing postoperative sagittal malalignment, the authors believe that surgical management should aim at a correction within the high normal kyphosis range of 40 degrees to 50 degrees, consequently providing good results and, particularly in flexible adolescents and young adults, minimizing the necessity for an anterior release.