The aim of this study is to determine if extended-release, bioabsorbable, subcutaneous naltrexone (NTX) implants can mitigate respiratory depression after an intravenous injection (IV) of fentanyl. Six different BIOabsorbable Polymeric Implant Naltrexone (BIOPIN) formulations, comprising combinations of Poly-d,l-Lactic Acid (PDLLA) and/or Polycaprolactone (PCL-1 or PCL-2), were used to create subcutaneous implants. Both placebo and naltrexone implants were implanted subcutaneously in male dogs. The active naltrexone implants consisted of two doses, 644 mg and 1288 mg. A challenge with IV fentanyl was performed in 33 male dogs at 97-100 days after implantation. Following the administration of a 30 μg/kg intravenous fentanyl dose, the placebo cohort manifested a swift and profound respiratory depression with a ~50% reduction in their pre-dose respiratory rate (RR). The BIOPIN NTX-implanted dogs were exposed to escalating doses of intravenous fentanyl (30 μg/kg, 60 μg/kg, 90 μg/kg, and 120 μg/kg). In contrast, the dogs implanted with the BIOPIN naltrexone implants tolerated doses up to 60 μg/kg without significant respiratory depression (<50%) but had severe respiratory depression with fentanyl doses of 90 μg/kg and especially at 120 μg/kg. Bioabsorbable, extended-release BIOPIN naltrexone implants are effective in mitigating fentanyl-induced respiratory depression in male canines at about 3 months after implantation. This technology may also have potential for mitigating fentanyl-induced respiratory depression in humans.

OBJECTIVE: Intra capsular fracture of the neck of femur (FNF) treated traditionally with a dynamic hip screw (DHS) or three cancellous screws (3CS) has a high incidence of complications with reoperation rates between 20 % and 45 %. We hypothesized that FNF unites by primary healing. Therefore, intra-operative compression and absolute stability post-operatively until healing are essential. We postulated that FNF requires 2 types of implants- those which provide absolute stability for young patients with good bone stock and another with sliding mechanism for elderly patients with osteoporosis. We developed three novel fixation systems at our research institute in India using a modified DHS. In patients with good bone stock, locking DHS, called LHS and GSK triangular system (GSKT) provided intra-operative compression and absolute stability during the post-operative period. In those with poor bone stock, the controlled sliding DHS (CSDHS)was used as a locking implant might penetrate the hip joint.
METHODS: 42 patients of FNF <55 years of age were studied. Among 39 patients with good bone stock, LHS was used in five patients and GSKT system was used in 34 patients. CSDHS was used in three patients with poor bone stock or communition. The patients were followed up for a minimum of eight months up to a maximum of two years, with the average follow up duration of 14 months.
RESULTS: 32 out of 34 fractures treated by GSKT system united. Five cases managed by LHS and three by CSDHS, all united. The union rate was 95.2 %. Of the two failed cases, one patient had nonunion (NU), the other had deep infection. Avascular necrosis of the head (AVN) was detected in three patients treated with GSKT system in the second year following surgery. Two of them had hip pain while one was asymptomatic. Eight cases of FNF Pauwels type III underwent a primary valgus osteotomy. All of them united without complications.
CONCLUSIONS: In patients with good bone stock, LHS and GSKT system allowed intra-operative compression and absolute post-operative stability without sliding of head fragment as the triangle construct is biomechanically the strongest. When bones are osteoporotic, a CSDHS provided controlled sliding (1 to 5 mm only). This pilot study showed a promising success rate of 95.2 %. We propose that the GSKT system may be used to treat intertrochanteric and other metaphyseal fractures as well. Further biomechanical studies are underway to strenghten the evidence needed for the widespread use of these implants.

Background: Pediatric forearm fractures represent a substantial proportion of childhood injuries, requiring effective and minimally invasive treatments. Our study investigated the mid-term outcomes of biodegradable poly-L-lactide-co-glycolide (PLGA) intramedullary implants in managing diaphyseal forearm fractures in children. Methods: A follow-up cohort study was conducted with 38 patients treated with PLGA implants. Control examinations were performed one year post-operation, assessing bone healing through radiographic evaluations and functional outcomes using injured and uninjured limb range of motion (ROM) comparisons. Scarring was evaluated employing the Vancouver Scar Scale (VSS), and satisfaction via a questionnaire. Results: Children were predominantly female (76.4%), with a mean age of 9.71 (SD: 2.69) years. Effective fracture stabilization and bone healing were found in all patients, with a minor reduction (mean difference of -1.5°, p = 0.282) in elbow flexion on the operated side (139.3°) compared to the intact (140.8°). Elbow extension presented negligible average changes (0.2°, p = 0.098). Forearm movements were slightly reduced on the operated side (mean pronation: 80.8° vs. 83.7°, p = 0.166; average supination: 83.5° vs. 85.7°, p = 0.141). Wrist palmar flexion and dorsiflexion showed no significant differences. VSS ratings indicated minimal scarring (mean guardian and doctor scores were 1.13 and 0.55, respectively, p = 0.020), and all patients reported satisfaction with the treatment outcomes. Conclusions: Biodegradable implants are effective for pediatric forearm fractures, providing stable bone healing while preserving functional ROM with minimal scarring and high patient satisfaction. PLGA proved to be a viable alternative to traditional metal implants, eliminating secondary removal surgeries.

BACKGROUND: This clinical study investigates platelet-rich fibrin\'s (PRF) impact on dental implant stability, addressing global oral health challenges and limitations of traditional methods. Emphasizing osseointegration\'s pivotal role, the study explores PRF\'s potential in enhancing implant stability, assessing it through resonance frequency analysis (RFA) and implant stability quotient (ISQ). The hypothesis suggests PRF may improve both primary and secondary stability, aiming to uncover clinical benefits in dental implant procedures Materials and methods: The study involved 24 subjects from the Department of Periodontics outpatient clinics with a meticulously designed methodology. This included a pre-surgical protocol with oral prophylaxis, impressions, and cone-beam computed tomography (CBCT) analysis. PRF preparation utilized a minimally invasive venipuncture technique. Implant placement followed a two-stage surgical protocol, assessing primary stability with MEGA ISQ (Ostell). Post-surgery, patients received instructions and underwent recall for secondary stability after three months. Clinical parameters such as plaque index (PI), gingival index (GI), implant probing pocket depth (IPPD), sulcus bleeding index (SBI), and implant stability (IS) were systematically recorded. Robust statistical analyses, using IBM SPSS Statistics for Windows v20.0 (IBM Corp., Armonk, USA) software, incorporated Mann-Whitney U and Wilcoxon signed-rank tests for group and within-time point comparisons, with a significance level of p<0.05. This comprehensive study yields nuanced insights into the impact of PRF and implant procedures on key clinical parameters, contributing significantly to the field.
RESULTS: This study compared dental implants with and without PRF in 24 patients. Both groups showed significant improvements in the PI, GI, and SBI. The PRF group exhibited higher IS in the third and sixth months, while IPPD was lower in the PRF group in the sixth month.
CONCLUSIONS: The findings of the study highlight a positive impact on implant stability contributing to better implant outcomes.

BACKGROUND: Different protocols and procedures for sinus lift and implant placement are available, generally involving the use of grafts to increase the tissue volume and/or prevent the Schneiderian membrane from collapsing. Among xenografts, deproteinised bovine bone graft (DBBP) is frequently used in sinus lift procedures. Leaving an ungrafted space following membrane elevation has proven to have a bony regenerative potential as well. This study aimed to compare the clinical and histological features of sinus lift surgery performed with or without biomaterials.
METHODS: Patients with severe maxillary posterior atrophy (residual bone height 2-6 mm and residual crest thickness ≥4 mm), and in need of sinus lift surgery to allow the placement of three implants were enrolled and randomly divided into two groups. They underwent sinus lifts with DBBP (control) or with a graftless technique (test) and immediate placement of two implants (a mesial and distal one). After 6 months, a bone sample was retrieved from the area between the previously inserted fixtures, and a third, central implant was placed. The collected bone samples were analyzed morphologically and histomorphometrically. The patients were provided with prosthetic restorations after 6 months and followed up for 5-12 years.
RESULTS: Ten patients were enrolled in the test and nine in the control group. The 6-month follow-up showed in the control group an average augmentation of 10.31 mm (±2.12), while in the test group it was 8.5 mm (±1.41) and a success rate of 96.3% in the control and 86.7% in the test group (p > 0.05). The histological analysis evidenced the presence of new bone tissue surrounded by immature osteoid matrix in the test group, and a variable number of DBBP particles surrounded by an immature woven bone matrix in the control group.
CONCLUSIONS: The results of the present trial indicate that, with residual bone height of 2-6 mm and residual crest thickness ≥4 mm, sinus lift surgery with or without biomaterials followed by implant restoration, produces similar clinical and histological outcomes.

BACKGROUND: The Norwegian Government introduced in 2002 a reimbursement scheme for hormonal contraceptives to adolescents at the same time as public health nurses and midwives received authorization to prescribe hormonal contraceptives. This study examines the impact of increased accessibility and public funding on hormonal contraceptive use among adolescents.
METHODS: The Norwegian Prescription Database, Statistics Norway, and Norwegian Institute of Public Health served as data sources for this cohort study. The study population comprised 174 653 Norwegian women born 1989-1990, 1994-1995, and 1999-2000. We examined use of hormonal contraceptives through dispensed prescriptions from age 12 through age 19 with duration of first continuous use as primary outcome. The statistical analyses were done in SPSS using chi-squared test, survival analysis, and Joinpoint regression analysis with p-values < 0.05.
RESULTS: By age 19, ~75% of the cohorts had used at least one hormonal method. The main providers of the first prescription were general practitioners and public health nurses. Starters of progestogen-only pills (POPs) have increased across the cohorts, while starters of combined oral contraceptives (COCs) have decreased. The use of long-acting reversible contraceptives (LARCs) has increased since its inclusion in the reimbursement scheme (2015). Most switchers shifted from COCs or POPs as a start method to implants after LARCs became part of the reimbursement scheme. There has been a significant increase across the cohorts in the number of women who continuously used hormonal contraceptives from start to the end of the calendar year they became 19 years with the same method and after switching methods. We could not correlate changes in decreasing trends for teenage births or induced abortions (Joinpoint analysis) to time for implementation or changes in the reimbursement of hormonal contraceptives from 2002.
CONCLUSIONS: Primarily public health nurses and to a lesser extent midwives became soon after they received authorization to prescribe COCs important providers. The expansion of the reimbursement scheme to cover POPs, patches, vaginal ring, and depot medroxyprogesterone acetate in 2006 had minor impact on increasing the proportion of long-term first-time users. However, the inclusion of LARCs in 2015 significantly increased the proportion of long-term first-time hormonal contraceptive users.

Background Intracapsular femoral neck fractures account for a majority of hip fractures. This study aimed to investigate the efficacy of valgus osteotomy as a primary treatment for intracapsular femoral neck fractures in adult patients aged 15-60 years, assessing its impact on functional outcomes and fracture union. Methodology A retrospective clinical analysis was conducted at the Department of Orthopedics and Traumatology, Osmania Government General Hospital, Hyderabad, India, focusing on patients treated with primary intertrochanteric valgus osteotomy for intracapsular femoral neck fractures. The study reviewed medical charts and radiographs of six patients aged between 15 and 60 years, diagnosed with recent isolated intracapsular femoral neck fractures, presenting between May 2019 and October 2021. The intervention involved Pauwels\' intertrochanteric valgus osteotomy with various fixation methods. Main outcome measures included radiographic union, functional ability assessed by the Harris Hip Score, and evaluation for complications. Results All six patients achieved radiographic union at fracture and osteotomy sites, totaling a 100% success rate. The average follow-up duration was 14.8 months (12-20 months), with an average time of 5.1 months (2.5-6 months) from surgery to radiographic union. One patient experienced union with retroversion, while another developed avascular necrosis (AVN) by the study\'s conclusion. No instances of hardware failure or non-union were observed. The average Harris Hip Score obtained during the most recent clinical follow-up was 84, ranging from 69 to 94. All six patients regained independent walking ability without any support by the end of the follow-up period. Conclusion The combination of primary Pauwels\' intertrochanteric valgus osteotomy with fixed-angle plating proves to be a highly effective method for addressing recent intracapsular femoral neck fractures, resulting in a 100% success rate in achieving union among the patient cohort.

The aim of the current study was to retrospectively investigate the prevalence of peri-implant mucositis (PIM) and peri-implantitis (P) in a long-term follow-up (≥20 years) of implants with the same body design and body surface but different collar surfaces with laser-microtextured grooves (LMGSs) vs. no laser-microtextured grooves (no-LMGSs) in private practice patients. Furthermore, several patient-related, implant-related, site-, surgical-, and prosthesis-related potential disease risk factors were analyzed. A chart review of patients receiving at least one pair of implants (one with an LMGS and the other without LMGS) in the period 1993-2002 was used. Chi-square analysis was used to determine if a statistically significant difference between the investigated variables and PIM/P was present. Possible risk factors were statistically evaluated by a binary logistic regression analysis. A total of 362 patients with 901 implant-supported restorations (438 with LMGS and 463 no-LMGS) were included in the study. The cumulative survival rates of implants at 5, 10, 15, and 20 years were 98.1%, 97.4%, 95.4%, and 89.8%, respectively, for the LMGS group, and 93.2%, 91.6%, 89.5%, and 78.3% for the no-LMGS group. The difference was statistically significant at all timepoints (p < 0.05). In total, at the end of the follow-up period, 45.7% of patients and 39.8% of implants presented PIM, and 15.6% of patients and 14% of implants presented P. A total of 164 LMGS implants (37.4%) and 195 no-LMGS implants (42.1%) presented peri-implant mucositis, while 28 (6.3%) of LMGS implants and 98 (21.1%) no-LMGS implants demonstrated peri-implantitis. Differences between LMGS implants and no-LMGS implants were statistically significant (p < 0.05). The binary logistic regression identified collar surface, cigarette smoking, histories of treated periodontitis, and lack of peri-implant maintenance as risk factors for P. After at least 20 years of function in patients followed privately, LMGS implants compared to no-LMGS implants presented a statistically and significantly lower incidence of P. Implant collar surface, cigarette smoking, previously treated periodontitis, and lack of peri-implant maintenance are factors with significant association to P.

UNASSIGNED: Clinical trials of innovative neural implants are rapidly increasing and diversifying, but little is known about participants\' post-trial access to the device and ongoing clinical care. This exploratory study examines common practices in the planning and coordination of post-trial access to neurosurgical devices. We also explore the perspectives of trial investigators on the barriers to post-trial access and ongoing care, as well as ethical questions related to the responsibilities of key stakeholder groups.
UNASSIGNED: Trial investigators (n=66) completed a survey on post-trial access in the most recent investigational trial of a surgically implanted neural device they had conducted. Survey respondents predominantly specialized in neurosurgery, neurology and psychiatry, with a mean of 14.8 years of experience working with implantable neural devices.
UNASSIGNED: Outcomes of interest included rates of device explantation during or at the conclusion of the trial (pre-follow-up) and whether plans for post-trial access were described in the study protocol. Outcomes also included investigators\' greatest \'barrier\' and \'facilitator\' to providing research participants with post-trial access to functional implants and perspectives on current arrangements for the sharing of post-trial responsibilities among key stakeholders.
UNASSIGNED: Trial investigators reported either \'all\' (64%) or \'most\' (33%) trial participants had remained implanted after the end of the trial, with \'infection\' and \'non-response\' the most common reasons for explantation. When asked to describe the main barriers to facilitating post-trial access, investigators described limited funding, scarcity of expertise and specialist clinical infrastructure and difficulties maintaining stakeholder relationships. Notwithstanding these barriers, investigators overwhelmingly (95%) agreed there is an ethical obligation to provide post-trial access when participants individually benefit during the trial.
UNASSIGNED: On occasions when devices were explanted during or at the end of the trial, this was done out of concern for the safety and well-being of participants. Further research into common practices in the post-trial phase is needed and essential to ethical and pragmatic discussions regarding stakeholder responsibilities.

OBJECTIVE: The aim of this study was to determine clinically and genetically the allergic effects of titanium and poly-ether-ether-ketone (PEEK) implants following loading in rabbit tibias.
METHODS: This study included 18 white New Zealand male rabbits (n = 18) divided evenly into three groups: control, titanium (Ti), and PEEK (P). Clinically, the allergenic effect of titanium and PEEK was investigated by detecting the effect on lymph nodes. Furthermore, RT-PCR and ELISA were used to detect the expression of certain genes IL-6, TNF-α, OPG, RANKL, and RUNX-2 through both types of implants.
RESULTS: Our findings demonstrated that titanium implants induced enlarged lymph nodes, which PEEK did not. Overall, RT-PCR and ELISA techniques revealed that Ti implants had higher expression of the inflammatory genes IL-6 and TNF-α. Ti had the highest expression in OPG findings, while PEEK had the lowest. RANKL expression was highest in the control group and lowest in the PEEK group. RUNX-2 is the highest for the control group and the lowest for the titanium group.
CONCLUSIONS: Although titanium implants elicited greater allergy responses than PEEK implants, titanium has the highest expression of bone formation genes and the lowest expression of bone resorption genes, making it preferable to PEEK.