Tonsillotomy for Periodic Fever Syndrome: A Randomized and Controlled Trial.

OBJECTIVE: Tonsillectomy is an effective treatment for periodic fever, aphthous stomatitis, pharyngitis, and cervical adenitis (PFAPA) syndrome. Tonsillotomy has a milder operative risk profile and postoperative morbidity in children than tonsillectomy. We aimed to compare the efficacy of tonsillotomy to observation-only in children with PFAPA syndrome at a 3-month follow-up. METHODS: This was a randomized multicenter trial with sequential design. Participants were randomized into a tonsillotomy group and a control group that was only observed. The trial started in 1/2017 and was accomplished in 12/2021 with 16 patients (10 boys, six girls, the mean age 4.2 years). The symptoms were monitored with daily symptom diaries. RESULTS: After the 3-month follow-up, 7/8 patients (87.5%) in the tonsillotomy group and 2/8 (25%) patients in the control group were free from PFAPA symptoms (95% CI 13% to 87%; p = 0.0021). The mean number of days with fever was 2.6 (SD 3.7) in the tonsillotomy group and 8.0 (SD 6.5) days in the control group (n = 8) (p = 0.06). Mean number of fever days compatible with PFAPA syndrome was 0.8 (SD 1.4) in the tonsillotomy group and 6.5 (SD 6.0) in the control group (95%CI -10% to -1%; p = 0.007). Rescue tonsillectomy was needed for all patients in the control group and none of the patients in the tonsillotomy group. CONCLUSIONS: Tonsillotomy might be an effective treatment option for children with PFAPA syndrome. Further studies are needed to clarify the long-term efficacy of tonsillotomy for treating PFAPA. LEVEL OF EVIDENCE: 2 Laryngoscope, 134:968-972, 2024.

Comparison of three common tonsil surgery techniques: cold steel with hot hemostasis, monopolar and bipolar diathermy.

PURPOSE: To analyze the risk of postoperative hemorrhage in tonsil surgery with different surgical methods, instruments, indications, and age groups. Monopolar diathermy compared to bipolar diathermy was of particular interest. METHODS: The data from tonsil surgery patients were retrospectively collected between 2012 and 2018 in the Hospital District of Southwest Finland. The surgical method, instruments, indication, sex and age and their association with a postoperative hemorrhage were analyzed. RESULTS: A total of 4434 patients were included. The postoperative hemorrhage rate for tonsillectomy was 6.3% and for tonsillotomy 2.2%. The most frequently used surgical instruments were monopolar diathermy (58.4%) cold steel with hot hemostasis (25.1%) and bipolar diathermy (6.4%) with the overall postoperative hemorrhage rates 6.1%, 5.9% and 8.1%, respectively. In tonsillectomy patients, the risk for a secondary hemorrhage was higher with bipolar diathermy compared to both monopolar diathermy (p = 0.039) and the cold steel with hot hemostasis technique (p = 0.029). However, between the monopolar and the cold steel with hot hemostasis groups, the difference was statistically non-significant (p = 0.646). Patients aged > 15 years had 2.6 times higher risk for postoperative hemorrhage. The risk of a secondary hemorrhage increased with tonsillitis as the indication, primary hemorrhage, tonsillectomy or tonsillotomy without adenoidectomy, and male sex in patients aged ≤ 15 years. CONCLUSION: Bipolar diathermy increased the risk for secondary bleedings compared to both monopolar diathermy and the cold steel with hot hemostasis technique in tonsillectomy patients. Monopolar diathermy did not significantly differ from the cold steel with hot hemostasis group regarding the bleeding rates.

Patient injuries from tonsil and adenoid surgery in Finland.

Objectives: The aims of this national register-based study were to examine patient injury claims related to tonsil and adenoid surgery injuries and to compare the frequency of claims between tonsillectomies and tonsillotomies in Finland. Methods: We analyzed the complaints related to tonsil and adenoid surgery received by the Finnish Patient Insurance Center (PIC) between the years 2000 and 2019. One hundred seventy-two cases were included in the analysis. The annual surgery rates between the years 2000 and 2018 were acquired from the Finnish Institute for Health and Welfare. Results: During the years 2000 to 2018, a total of 292,679 patients had tonsil and/or adenoid surgery nationwide. For tonsil or adenoid surgeries, the national average was 5.3 cases and 1.8 cases per 10,000, respectively, resulting in patient injury claims and compensations. A total of 33.1% of the claims regarding tonsil or adenoid surgery processed by the PIC were compensated. Most of the claims were made after a tonsillectomy (87.8%), and few were made after a tonsillotomy (1.7%). Seven deaths were recorded. Conclusion: Patient injuries from tonsil and adenoid surgeries were mostly related to traditional extracapsular tonsillectomies. Most surgeries, along with most complications, involved specialists, who performed routine operations in high-volume centers. Surgeries for acute or recurrent infections resulted in more claims. Severe complications arising from tonsil and adenoid surgeries were rare. Level of Evidence: 4.

Intracapsular tonsillectomy in the treatment of recurrent and chronic tonsillitis in adults: a protocol of a prospective, single-blinded, randomised study with a 5-year follow-up (the FINITE trial).

INTRODUCTION: The standard surgical treatment for recurrent or chronic tonsillitis is extracapsular tonsillectomy. Recent studies show that intracapsular tonsillectomy has the potential to reduce the postoperative morbidity of patients undergoing tonsil surgery. The Finnish Intracapsular Tonsillectomy (FINITE) trial aims to provide level I evidence to support the hypothesis that the recovery time from tonsil surgery can be reduced with intracapsular tonsillectomy. Additionally, from this trial, major benefits in quality of life, reduction of postoperative complications, treatment costs and throat symptoms might be gained. METHODS AND ANALYSIS: The FINITE trial is a prospective, randomised, controlled, patient-blinded, three-arm clinical trial. It is designed to compare three different surgical methods being extracapsular monopolar tonsillectomy versus intracapsular microdebrider tonsillectomy versus intracapsular coblation tonsillectomy in the treatment of adult patients (16-65 years) suffering from recurrent or chronic tonsillitis. The study started in September 2019, and patients will be enrolled until a maximum of 200 patients are randomised. Currently, we are in the middle of the study with 125 patients enrolled as of 28 February 2022 and data collection is scheduled to be completed totally by December 2027. The primary endpoint of the study will be the recovery time from surgery. Secondary endpoints will be the postoperative pain scores and the use of analgesics during the first 3 weeks of recovery, postoperative haemorrhage, quality of life, tonsillar remnants, need for revision surgery, throat symptoms, treatment costs and sick leave. A follow-up by a questionnaire at 1-21 days and at 1, 6, 24 and 60 months will be conducted with a follow-up visit at the 6-month time point. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Medical Ethics Committee of the Hospital District of Southwest Finland (reference number 29/1801/2019). Results will be made publicly available in peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: NCT03654742.

Treatment of sleep apnoea with tonsillectomy: a retrospective analysis using long-term follow-up data.

PURPOSE: This single-group, retrospective, pre-test-post-test study was performed to examine clinical outcomes in treating obstructive sleep apnoea (OSA) with tonsillectomy alone and had the longest follow-up periods to date. METHODS: We analysed 151 tonsillectomies in our district between the years 2004 and 2018 that had either sleep apnoea or snoring listed as a diagnosis. Twenty-one patients met our criteria and were included. Patient records were analysed for home sleep apnoea test and Epworth Sleepiness Scale (ESS) scores. RESULTS: We defined success as a > 50% reduction of the Apnoea-Hypopnea Index (AHI) and a total AHI of < 20 post-surgery. The averages before surgery were an AHI of 22.3 and an ESS of 7.22. The success rate was 47.6% after tonsillectomy as the sole treatment for obstructive sleep apnoea in our adult population. Eleven patients were non-responders. The average ESS score reduction was 0.69 and did not reach statistical significance. With follow-up times ranging from 1.8 to 171 months, this study had the longest follow-up period compared to other existing studies. No patient with a follow-up longer than one year was a responder. CONCLUSION: Our results support that tonsillectomy is an effective treatment for obstructive sleep apnoea in adults with tonsillar hypertrophy. With less severe OSA than those reported on previously, our patients also had less severe daytime sleepiness before surgery, and daytime sleepiness score reductions did not reach statistical significance. In the future, long-term results should be further analysed.

Biomaterial and implant induced ossification: in vitro and in vivo findings.

Material-induced ossification is suggested as a suitable approach to heal large bone defects. Fiber-reinforced composite-bioactive glasses (FRC-BGs) display properties that could enhance the ossification of calvarial defects. Here, we analyzed the healing processes of a FRC-BG implant in vivo from the perspective of material-induced ossification. Histological analysis of the implant, which was removed 5 months after insertion, showed the formation of viable, noninflammatory mesenchymal tissue with newly-formed mineralized woven bone, as well as nonmineralized connective tissue with capillaries and larger blood vessels. The presence of osteocytes was detected within the newly generated bone matrix. To expand our understanding on the osteogenic properties of FRC-BG, we cultured human adipose tissue-derived mesenchymal stromal cells (AD-MSCs) in the presence of two different BGs (45S5 and S53P4) and Al2 O3 control. AD-MSCs grew and proliferated on all the scaffolds tested, as well as secreted abundant extracellular matrix, when osteogenic differentiation was appropriately stimulated. 45S5 and S53P4 induced enhanced expression of COL2A1, COL10A1, COL5A1 collagen subunits, and pro-osteogenic genes BMP2 and BMP4. The concomitant downregulation of BMP3 was also detected. Our findings show that FRC-BG can support the vascularization of the implant and the formation of abundant connective tissue in vivo. Specifically, BG 45S5 and BG S53P4 are suited to evoke the osteogenic potential of host mesenchymal stromal cells. In conclusion, FRC-BG implant demonstrated material-induced ossification both in vitro and in vivo.

A Large Calvarial Bone Defect in a Child: Osseointegration of an Implant.

BACKGROUND: This original report describes the outcome of a cranioplasty at long-term follow-up. A large calvarial bone defect of a child was reconstructed with a bioactive and biostable nonmetallic implant. CASE DESCRIPTION: In a child with infantile fibrosarcoma of occipital bone, the malignancy was removed at 2.5 years of age, and the defect site was reconstructed with an onlay glass fiber-reinforced composite-bioactive glass implant. The follow-up examination at 5 years 7 months showed no signs of tumor recurrence. During the follow-up period, the contour of the reconstructed area followed skull anatomic development. Computed tomography demonstrated considerably large areas (approximately 70% of the total area) of bone ongrowth to the peridural surface of the implant. CONCLUSIONS: In the future, a synthetic cranioplasty material that is able to integrate with cranial bone may be considered superior to cryopreserved bone grafts in younger age groups.

Predictors of primary autograft cranioplasty survival and resorption after craniectomy.

OBJECTIVECraniectomy is a common neurosurgical procedure that reduces intracranial pressure, but survival necessitates cranioplasty at a later stage, after recovery from the primary insult. Complications such as infection and resorption of the autologous bone flap are common. The risk factors for complications and subsequent bone flap removal are unclear. The aim of this multicenter, retrospective study was to evaluate the factors affecting the outcome of primary autologous cranioplasty, with special emphasis on bone flap resorption.METHODSThe authors identified all patients who underwent primary autologous cranioplasty at 3 tertiary-level university hospitals between 2002 and 2015. Patients underwent follow-up until bone flap removal, death, or December 31, 2015.RESULTSThe cohort comprised 207 patients with a mean follow-up period of 3.7 years (SD 2.7 years). The overall complication rate was 39.6% (82/207), the bone flap removal rate was 19.3% (40/207), and 11 patients (5.3%) died during the follow-up period. Smoking (OR 3.23, 95% CI 1.50-6.95; p = 0.003) and age younger than 45 years (OR 2.29, 95% CI 1.07-4.89; p = 0.032) were found to independently predict subsequent autograft removal, while age younger than 30 years was found to independently predict clinically relevant bone flap resorption (OR 4.59, 95% CI 1.15-18.34; p = 0.03). The interval between craniectomy and cranioplasty was not found to predict either bone flap removal or resorption.CONCLUSIONSIn this large, multicenter cohort of patients with autologous cranioplasty, smoking and younger age predicted complications leading to bone flap removal. Very young age predicted bone flap resorption. The authors recommend that physicians extensively inform their patients of the pronounced risks of smoking before cranioplasty.

Cranioplasty After Severe Traumatic Brain Injury: Effects of Trauma and Patient Recovery on Cranioplasty Outcome.

BACKGROUND: In patients with severe traumatic brain injury (sTBI) treated with decompressive craniectomy (DC), factors affecting the success of later cranioplasty are poorly known. OBJECTIVE: We sought to investigate if injury- and treatment-related factors, and state of recovery could predict the risk of major complications in cranioplasty requiring implant removal, and how these complications affect the outcome. METHODS: A retrospective cohort of 40 patients with DC following sTBI and subsequent cranioplasty was studied. Non-injury-related factors were compared with a reference population of 115 patients with DC due to other conditions. RESULTS: Outcome assessed 1 day before cranioplasty did not predict major complications leading to implant removal. Successful cranioplasty was associated with better outcome, whereas a major complication attenuates patient recovery: in patients with favorable outcome assessed 1 year after cranioplasty, major complication rate was 7%, while in patients with unfavorable outcome the rate was 42% (p = 0.003). Of patients with traumatic subarachnoid hemorrhage (tSAH) on admission imaging 30% developed a major complication, while none of patients without tSAH had a major complication (p = 0.014). Other imaging findings, age, admission Glasgow Coma Scale, extracranial injuries, length of stay at intensive care unit, cranioplasty materials, and timing of cranioplasty were not associated with major complications. CONCLUSION: A successful cranioplasty after sTBI and DC predicts favorable outcome 1 year after cranioplasty, while stage of recovery before cranioplasty does not predict cranioplasty success or failure. tSAH on admission imaging is a major risk factor for a major complication leading to implant removal.

Load-bearing capacity and fracture behavior of glass fiber-reinforced composite cranioplasty implants.

BACKGROUND: Glass fiber-reinforced composites (FRCs) have been adapted for routine clinical use in various dental restorations and are presently also used in cranial implants. The aim of this study was to measure the load-bearing capacity and failure type of glass FRC implants during static loading with and without interconnective bars and with different fixation modes. METHODS: Load-bearing capacities of 2 types of FRC implants with 4 different fixation modes were experimentally tested. The sandwich-like FRC implants were made of 2 sheets of woven FRC fabric, which consisted of silanized, woven E-glass fiber fabrics impregnated in BisGMA-TEGDMA monomer resin matrix. The space between the outer and inner surfaces was filled with glass particles. All FRC implants were tested up to a 10-mm deflection with load-bearing capacity determined at 6-mm deflection. The experimental groups were compared using nonparametric Kruskal-Wallis analysis with Steel-Dwass post hoc test. RESULTS: FRC implants underwent elastic and plastic deformation until 6-mm deflection. The loading test did not demonstrate any protrusions of glass fibers or cut fiber even at 10-mm deflection. An elastic and plastic deformation of the implant occurred until the FRC sheets were separated from each other. In the cases of the free-standing setup (no fixation) and the fixation with 6 screws, the FRC implants with 2 interconnective bars showed a significantly higher load-bearing capacity compared with the implant without interconnective bars. CONCLUSIONS: FRC implants used in this study showed a load-bearing capacity which may provide protection for the brain after cranial bone defect reconstruction.

A glass fiber-reinforced composite - bioactive glass cranioplasty implant: A case study of an early development stage implant removed due to a late infection.

This case study describes the properties of an early development stage bioactive glass containing fiber-reinforced composite calvarial implant with histology that has been in function for two years and three months. The patient is a 33-year old woman with a history of substance abuse, who sustained a severe traumatic brain injury later unsuccessfully treated with an autologous bone flap and a custom-made porous polyethylene implant. She was thereafter treated with developmental stage glass fiber-reinforced composite - bioactive glass implant. After two years and three months, the implant was removed due to an implant site infection. The implant was analyzed histologically, mechanically, and in terms of chemistry and dissolution of bioactive glass. Mechanical integrity of the load bearing fiber-reinforced composite part of the implant was not affected by the in vivo period. Bioactive glass particles demonstrated surface layers of hydroxyapatite like mineral and dissolution, and related increase of pH was considerably less after two and three months period than that for fresh bioactive glass. There was a difference in the histology of the tissues inside the implant areas near to the margin of the implant that absorbed blood during implant installation surgery, showed fibrous tissue with blood vessels, osteoblasts, collagenous fibers with osteoid formation, and tiny clusters of more mature hard tissue. In the center of the implant, where there was less absorbed blood, only fibrous tissue was observed. This finding is in line with the combined positron emission tomography - computed tomography examination with (18F)-fluoride marker, which demonstrated activity of the mineralizing bone by osteoblasts especially at the area near to the margin of the implant 10 months after implantation. Based on these promising reactions found in the bioactive glass containing fiber-reinforced composite implant that has been implanted for two years and three months, calvarial reconstruction with the presented material appears to be a feasible method.

Paediatric cranial defect reconstruction using bioactive fibre-reinforced composite implant: early outcomes.

BACKGROUND: In children, approximately half of cryopreserved allograft bone flaps fail due to infection and resorption. Synthetic materials offer a solution for allograft bone flap resorption. Fibre-reinforced composite with a bioactive glass particulate filling is a new synthetic material for bone reconstruction. Bioactive glass is capable of chemically bonding with bone and is osteoinductive, osteoconductive and bacteriostatic. Fibre-reinforced composite allows for fabricating thin (0.8 mm) margins for implant, which are designed as onlays on the existing bone. Bioactive glass is dissolved over time, whereas the fibre-reinforced composite serves as a biostable part of the implant, and these have been tested in preclinical and adult clinical trials. In this study, we tested the safety and other required properties of this composite material in large skull bone reconstruction with children. METHOD: Eight cranioplasties were performed on seven patients, aged 2.5-16 years and having large (>16 cm(2)) skull bone defects. The implant used in this study was a patient-specific, glass-fibre-reinforced composite, which contained a bioactive glass particulate compound, S53P4. RESULTS: During follow-up (average 35.1 months), one minor complication was observed and three patients needed revision surgery. Two surgical site infections were observed. After treatment of complications, a good functional and cosmetic outcome was observed in all patients. The implants had an onlay design and fitted the defect well. In clinical and imaging examinations, the implants were in the original position with no signs of implant migration, degradation or mechanical breakage. CONCLUSIONS: Here, we found that early cranioplasty outcomes with the fibre-reinforced composite implant were promising. However, a longer follow-up time and a larger group of patients are needed to draw firmer conclusions regarding the long-term benefits of the proposed novel biomaterial and implant design. The glass-fibre-reinforced composite implant incorporated by particles of bioactive glass may offer an original, non-metallic and bioactive alternative for reconstruction of large skull bone defects in a paediatric population.

Outcomes of cranioplasty with synthetic materials and autologous bone grafts.

OBJECTIVE: Using current surgical methods, cranioplasty is associated with a high complication rate. We analyzed if there are preexisting medical conditions associated with complications and compared the effect of different implant materials on the degree of complications. METHODS: A retrospective review of the medical records of all patients who underwent cranioplasty for cranial bone defects during the period 2002-2012 was conducted, and 100 consecutive cranioplasty procedures that met eligibility criteria were identified. Patients were analyzed in 4 groups, which were created based on the cranioplasty material: autograft (n = 20), bioactive fiber-reinforced composite (n = 20), hydroxyapatite (n = 31), and other synthetic materials (n = 29). Survival estimates were constructed with Kaplan-Meier curves, and the differences between categorical variable levels were determined using a log-rank test. Multiple comparisons were adjusted using a Sidák correction. RESULTS: During a median follow-up time of 14 months (interquartile range 3-39 months), 32 of 100 patients (32.0%) developed at least 1 complication. A minor complication occurred in 13 patients (13.0%), whereas 19 patients (19.0%) developed a major complication, which required reoperation or removal of the implant. In the autograft subgroup, 40.0% of patients required removal of the cranioplasty. The 3-year survival of the autograft subgroup was lower compared with other subgroups of synthetic materials. In hydroxyapatite and bioactive fiber-reinforced composite groups, fewer complications were observed compared with the autograft group. CONCLUSIONS: Based on these results, synthetic materials for cranial bone defect reconstruction exhibit more promising outcomes compared with autograft. There were differences in survival rates among synthetic materials.

Craniofacial bone reconstruction with bioactive fiber-reinforced composite implant.

BACKGROUND: A novel, bioactive, fiber-reinforced composite implant is a solution to address the shortcomings in craniofacial bone reconstruction. A longitudinal clinical investigation with a follow-up time of 4 years was conducted. METHODS: A cranial bone reconstruction with the implant was performed on 12 patients. In these patients, the reasons for craniotomies resulting in craniofacial bone defects were traumatic and spontaneous intracranial bleeding as well as infections to the primary reconstruction material. The implant material consisted of a supporting fiber-reinforced framework, porous inner layers, and a bioactive glass (BG; S53P4) filling. The framework and the porous layers were made of a bisphenol-a-glycidyl methacrylate and triethyleneglycoldi-methacrylate (pBisGMA-pTEGDMA) resin matrix, which was reinforced with silanized E-glass. RESULTS: In clinical examinations and skull X-rays, the implants were in original positions providing the expected functional and aesthetic outcome at all time points. CONCLUSION: The implants functioned appropriately, which would provide a potential solution for craniofacial bone reconstruction in the future.