Systemic modulation of skeletal mineralization by magnesium implant promoting fracture healing: Radiological exploration enhanced with PCA-based machine learning in a rat femoral model

The clinical application of magnesium(Mg)and its alloys for bone fractures has been well supported by in vitro and in vivo trials.However,there were studies indicating negative effects of high dose Mg intake and sustained local release of Mg ions on bone metabolism or repair,which should not be ignored when developing Mg-based implants.Thus,it remains necessary to assess the biological effects of Mg implants in animal models relevant to clinical treatment modalities.The primary purpose of this study was to validate the beneficial effects of intramedullary Mg implants on the healing outcome of femoral fractures in a modified rat model.In addition,the mineralization parameters at multiple anatomical sites were evaluated,to investigate their association with healing outcome and potential clinical applications.Compared to the control group without Mg implantation,postoperative imaging at week 12 demonstrated better healing outcomes in the Mg group,with more stable unions in 3D analysis and high-mineralized bridging in 2D evaluation.The bone tissue mineral density(TMD)was higher in the Mg group at the non-operated femur and lumbar vertebra,while no differences between groups were identified regarding the bone tissue volume(TV),TMD and bone mineral content(BMC)in humerus.In the surgical femur,the Mg group presented higher TMD,but lower TV and BMC in the distal metaphyseal region,as well as reduced BMC at the osteotomy site.Principal component analysis(PCA)-based machine learning revealed that by selecting clinically relevant parameters,radiological markers could be constructed for differentiation of healing outcomes,with better performance than 2D scoring.The study provides insights and preclinical evidence for the rational investigation of bioactive materials,the identification of potential adverse effects,and the promotion of diagnostic capabilities for fracture healing.

A tantalum-containing zirconium-based metallic glass with superior endosseous implant relevant properties

Zirconium-based metallic glasses(Zr-MGs)are demonstrated to exhibit high mechanical strength,low elastic modulus and excellent biocompatibility,making them promising materials for endosseous implants.Meanwhile,tantalum(Ta)is also well known for its ideal corrosion resistance and biological effects.However,the metal has an elastic modulus as high as 186 GPa which is not comparable to the natural bone(10–30 GPa),and it also has a relative high cost.Here,to fully exploit the advantages of Ta as endosseous implants,a small amount of Ta(as low as 3 at.%)was successfully added into a Zr-MG to generate an advanced functional endosseous implant,Zr58Cu25Al14Ta3 MG,with superior comprehensive properties.Upon carefully dissecting the atomic structure and surface chemistry,the results show that amorphization of Ta enables the uniform distribution in material surface,leading to a significantly improved chemical stability and extensive material-cell contact regulation.Systematical analyses on the immunological,angiogenesis and osteogenesis capability of the material are carried out utilizing the next-generation sequencing,revealing that Zr_(58)Cu_(25)Al_(14)Ta_(3)MG can regulate angiogenesis through VEGF signaling pathway and osteogenesis via BMP signaling pathway.Animal experiment further confirms a sound osseointegration of Zr_(58)Cu_(25)Al_(14)Ta_(3)MG in achieving better bone-implant-contact and inducing faster periimplant bone formation.

Deep brain implantable microelectrode arrays for detection and functional localization of the subthalamic nucleus in rats with Parkinson’s disease

The subthalamic nucleus(STN)is considered the best target for deep brain stimulation treatments of Parkinson’s disease(PD).It is difficult to localize the STN due to its small size and deep location.Multichannel microelectrode arrays(MEAs)can rapidly and precisely locate the STN,which is important for precise stimulation.In this paper,16-channel MEAs modified with multiwalled carbon nanotube/poly(3,4-ethylenedioxythiophene):poly(styrene sulfonate)(MWCNT/PEDOT:PSS)nanocomposites were designed and fabricated,and the accurate and rapid identification of the STN in PD rats was performed using detection sites distributed at different brain depths.These results showed that nuclei in 6-hydroxydopamine hydrobromide(6-OHDA)-lesioned brains discharged more intensely than those in unlesioned brains.In addition,the MEA simultaneously acquired neural signals from both the STN and the upper or lower boundary nuclei of the STN.Moreover,higher values of spike firing rate,spike amplitude,local field potential(LFP)power,and beta oscillations were detected in the STN of the 6-OHDA-lesioned brain,and may therefore be biomarkers of STN localization.Compared with the STNs of unlesioned brains,the power spectral density of spikes and LFPs synchronously decreased in the delta band and increased in the beta band of 6-OHDA-lesioned brains.This may be a cause of sleep and motor disorders associated with PD.Overall,this work describes a new cellular-level localization and detection method and provides a tool for future studies of deep brain nuclei.

Additively manufactured Ti–Ta–Cu alloys for the next-generation load-bearing implants

Bacterial colonization of orthopedic implants is one of the leading causes of failure and clinical complexities for load-bearing metallic implants. Topical or systemic administration of antibiotics may not offer the most efficient defense against colonization, especially in the case of secondary infection, leading to surgical removal of implants and in some cases even limbs. In this study, laser powder bed fusion was implemented to fabricate Ti3Al2V alloy by a 1:1 weight mixture of CpTi and Ti6Al4V powders. Ti-Tantalum(Ta)–Copper(Cu) alloys were further analyzed by the addition of Ta and Cu into the Ti3Al2V custom alloy. The biological,mechanical, and tribo-biocorrosion properties of Ti3Al2V alloy were evaluated. A 10 wt.% Ta(10Ta) and 3 wt.% Cu(3Cu) were added to the Ti3Al2V alloy to enhance biocompatibility and impart inherent bacterial resistance. Additively manufactured implants were investigated for resistance against Pseudomonas aeruginosa and Staphylococcus aureus strains of bacteria for up to 48 h. A 3 wt.% Cu addition to Ti3Al2V displayed improved antibacterial efficacy, i.e.78%–86% with respect to CpTi. Mechanical properties for Ti3Al2V–10Ta–3Cu alloy were evaluated, demonstrating excellent fatigue resistance, exceptional shear strength, and improved tribological and tribo-biocorrosion characteristics when compared to Ti6Al4V. In vivo studies using a rat distal femur model revealed improved early-stage osseointegration for alloys with10 wt.% Ta addition compared to CpTi and Ti6Al4V. The 3 wt.% Cu-added compositions displayed biocompatibility and no adverse infammatory response in vivo. Our results establish the Ti3Al2V–10Ta–3Cu alloy’s synergistic effect on improving both in vivo biocompatibility and microbial resistance for the next generation of load-bearing metallic implants.

Current knowledge for the risk factors of early permanent pacemaker implantation following transcatheter aortic valve replacement and what is next for the primary prevention?

In this editorial,we comprehensively summarized the preoperative risk factors of early permanent pacemaker implantation after transcatheter aortic valve replacement(TAVR)among patients with severe aortic stenosis from several renowned clinical studies and focused on the primary prevention of managing the modifiable factors,e.g.,paroxysmal atrial fibrillation before the TAVR.

Impact of High Sodium Diet on Neovascularization and Osseointegration around Titanium Implant:An in Vivo and in Vitro Study

Objective A high sodium(HS)diet is believed to affect bone metabolism processes.Clarifying its impact on osseointegration of titanium(Ti)implants holds significant implications for postoperative dietary management of implanted patients.Methods This investigation probed the impact of sodium ions(Na^(+))on neovascularization and osteogenesis around Ti implants in vivo,utilizing micro-computed tomography,hematoxylin and eosin staining,and immunohistochemical analyses.Concurrently,in vitro experiments assessed the effects of varied Na^(+)concentrations and exposure durations on human umbilical vein endothelial cells(HUVECs)and MC3T3-E1 cells.Results In vivo,increased dietary sodium(0.8%-6.0%)led to a substantial decline in CD34 positive HUVECs and new bone formation around Ti implants,alongside an increase in inflammatory cells.In vitro,an increase in Na^(+)concentration(140-150 mmol/L)adversely affected the proliferation,angiogenesis,and migration of HUVECs,especially with prolonged exposure.While MC3T3-E1 cells initially exhibited less susceptibility to high Na^(+)concentrations compared to HUVECs during short-term exposure,prolonged exposure to a HS environment progressively diminished their proliferation,differentiation,and osteogenic capabilities.Conclusion These findings suggest that HS diet had a negative effect on the early osseointegration of Ti implants by interfering with the process of postoperative vascularized bone regeneration.

Is primary transcatheter aortic valve implantation the new normal?

Degenerative calcific aortic valve stenosis(AS)is the most common valvular heart disease in elderly.^[1] It is well documented that symptomatic severe AS follows a malignant course leading to cardiogenic shock(CS).

Transcatheter aortic valve implantation versus surgery:4-year survival according to life expectancy

Background In the last years,transcatheter aortic valve implantation(TAVI)indication has expanded to younger and lower risk patients.Consequently,interest in mid and long-term follow up and in the role of life expectancy,as a key factor for selecting the most tailored treatment,has grown.The aim of this retrospective study is to compare the 4-year survival of patients who underwent aortic valve replacement(AVR)vs.TAVI at our department.Methods From September 2017 to December 2020,673 consecutive patients with severe aortic valve stenosis were enrolled for AVR(n=283)or TAVI(n=390).Inclusion criteria was isolated severe aortic stenosis,while exclusion criteria were redo surgery,valve-in-valve procedure and the need for concomitant surgical procedures.Based on the Lee index,patients were divided into four groups according to their 4-year life expectancy.Four-year survival was assessed and reported using the Kaplan-Meier method.A multivariate regression analysis of risk factors for 4-year mortality was performed.Results Four years survival is always superior in the AVR patients(89.8%vs.75.6%,P<0.001).Surgery is associated with a higher incidence of acute kidney injury(23%vs.5.1%,P<0.001),while TAVI is related to a higher incidence of new onset left bundle branch block(0 vs.23.8%,P<0.001),pace-maker implantation(2.5%vs.11.8%,P=0,02)and mild-to-moderate paravalvular leak(0.3%vs.5.4%,P<0.001).The independent risk factors for 4-years mortality are post-procedural AKI,poor mobility and transcatheter procedure.Conclusion In our analysis,4 years survival is always superior in the AVR patients.Life expectancy is a key factor for selecting the most appropriate approach for each patient.A longer follow up is mandatory before extending TAVI indication to patients with a long-life expectancy.

Delayed endophthalmitis caused by Gordonia bronchialis after intraocular collamer lens implantation

Dear Editor,We report a case of bacterial endophthalmitis following implantation of a Staar intraocular collamer lens(ICL)caused by Gordonia bronchialis.ICL implantation is an effective method to correct myopia which generally offers excellent safety.There are a few reports of ocular infection caused by Gordonia bronchialis,but no ICL-related endophthalmitis has been reported to date.We present the first case of delayed-onset endophthalmitis after ICL implantation caused by Gordonia bronchialis,identified by metagenomic next-generation sequencing(mNGS).

Nursing Care and Causative Analysis of Grade IV Capsular Contracture Following Breast Cancer Expander Implantation

Objective: By observing the treatment and nursing care of a patient with Grade IV capsular contracture following breast cancer expander implantation and subsequent Stage II reconstruction, we aim to analyze the reasons for the formation of capsular contracture after Stage I expander implantation and prevent its recurrence following Stage II reconstruction. Methods: In May 2020, the patient noticed an increase in the size of a breast mass. In August, she underwent AC-THP neoadjuvant chemotherapy, followed by a “right breast-conserving nipple-areolar subglandular excision + right axillary lymph node dissection + expander implantation” surgery in November 2020. Radiation therapy began in January 2021. During radiation therapy, the patient experienced severe breast hardening, distortion, tenderness, and was diagnosed with Grade IV capsular contracture. To relieve the capsular contracture, the patient underwent a “contracted capsule incision and release procedure + removal of the right breast expander + right breast implantation” surgery in July 2021. Postoperatively, measures were taken to prevent incision infection, emphasizing aseptic techniques, ensuring smooth negative pressure drainage, reducing skin flap tension, monitoring skin flap blood supply, actively preventing subcutaneous effusion and hematoma, and applying appropriate compression dressings. Results: The patient was discharged after the removal of the drainage tube. During the postoperative follow-up at 3 and 6 months, there was no recurrence of capsular contracture, and the breast appeared full, upright, and relatively soft. There were no complications such as hematoma, infection, breast implant rupture, breast sagging, or displacement. The patient had a good outcome without additional financial or surgical burdens. Conclusion: The occurrence of Grade IV capsular contracture in the patient is generally related to infection after Stage I expander implantation, improper compression dressing, excessive saline injection causing content infiltration, and radiation therapy. Therefore, it is recommended to enhance the intraoperative and postoperative prophylactic use of antibiotics after Stage I expander implantation. Intermittent saline injection after surgery, with the amount of saline gradually increasing rather than filling all at once, is advisable. This helps the breast tissue gradually adapt to expansion, reducing the risk of capsular contracture. Postoperatively, patients should be instructed to wear pressure garments and breast elastic bandages while intensifying breast monitoring during radiation therapy and increasing postoperative follow-up.

Burden of routine orthopedic implant removal a single center retrospective study

BACKGROUND Open reduction and internal fixation represent prevalent orthopedic procedures,sparking ongoing discourse over whether to retain or remove asymptomatic implants.Achieving consensus on this matter is paramount for orthopedic surgeons.This study aims to quantify the impact of routine implant removal on patients and healthcare facilities.A retrospective analysis of implant removal cases from 2016 to 2022 at King Fahad Hospital of the University(KFHU)was conducted and subjected to statistical scrutiny.Among these cases,44%necessitated hospitalization exceeding one day,while 56%required only a single day.Adults exhibited a 55%need for extended hospital stays,contrasting with 22.8%among the pediatric cohort.The complication rate was 6%,with all patients experiencing at least one complication.Notably,34.1%required sick leave and 4.8%exceeded 14 d.General anesthesia was predominant(88%).Routine implant removal introduces unwarranted complications,particularly in adults,potentially prolonging hospitalization.This procedure strains hospital resources,tying up the operating room that could otherwise accommodate critical surgeries.Clearly defined institutional guidelines are imperative to regulate this practice.AIM To measure the burden of routine implant removal on the patients and hospital.METHODS This is a retrospective analysis study of 167 routine implant removal cases treated at KFHU,a tertiary hospital in Saudi Arabia.Data were collected in the orthopedic department at KFHU from February 2016 to August 2022,which includes routine asymptomatic implant removal cases across all age categories.Nonroutine indications such as infection,pain,implant failure,malunion,nonunion,restricted range of motion,and prominent hardware were excluded.Patients who had external fixators removed or joints replaced were also excluded.RESULTS Between February 2016 and August 2022,360 implants were retrieved;however,only 167 of those who met the inclusion criteria were included in this study.The remaining implants were rejected due to exclusion criteria.Among the cases,44%required more than one day in the hospital,whereas 56%required only one day.55%of adults required more than one day of hospitalization,while 22.8%of pediatric patients required more than one day of inpatient care.The complication rate was 6%,with each patient experiencing at least one complication.Sick leave was required in 34.1%of cases,with 4.8%requiring more than 14 d.The most common type of anesthesia used in the surgeries was general anesthesia(88%),and the mean(SD)surgery duration was 77.1(54.7)min.CONCLUSION Routine implant removal causes unnecessary complications,prolongs hospital stays,depletes resources and monopolizing operating rooms that could serve more critical procedures.

In‑depth proteome characterization of endometrium and extraembryonic membranes during implantation in pig

Background Proteome characterization of the porcine endometrium and extraembryonic membranes is important to understand mother-embryo cross-communication.In this study,the proteome of the endometrium and cho-rioallantoic membrane was characterized in pregnant sows(PS)during early gestation(d 18 and 24 of gestation)and in the endometrium of non-pregnant sows(NPS)during the same days using LC-MS/MS analysis.The UniProtKB database and ClueGO were used to obtain functional Gene Ontology annotations and biological and functional networks,respectively.Results Our analysis yielded 3,254 and 3,457 proteins identified in the endometrium of PS and NPS,respectively;of these,1,753 being common while 1,501 and 1,704 were exclusive to PS and NPS,respectively.In addition,we iden-tified 3,968 proteins in the extraembryonic membranes of PS.Further analyses of function revealed some proteins had relevance for the immune system process and biological adhesion in endometrium while the embryonic chorion displayed abundance of proteins related to cell adhesion and cytoskeletal organization,suggesting they dominated the moment of endometrial remodeling,implantation and adhesion of the lining epithelia.Data are available via Pro-teomeXchange with identifier PXD042565.Conclusion This is the first in-depth proteomic characterization of the endometrium and extraembryonic mem-branes during weeks 3 to 4 of gestation;data that contribute to the molecular understanding of the dynamic environ-ment during this critical period,associated with the majority of pregnancy losses.

Graphene-calcium carbonate coating to improve the degradation resistance and mechanical integrity of a biodegradable implant

Biodegradable implants are critical for regenerative orthopaedic procedures,but they may suffer from too fast corrosion in human-body environment.This necessitates the synthesis of a suitable coating that may improve the corrosion resistance of these implants without compromising their mechanical integrity.In this study,an AZ91 magnesium alloy,as a representative for a biodegradable Mg implant material,was modified with a thin reduced graphene oxide(RGO)-calcium carbonate(CaCO_(3))composite coating.Detailed analytical and in-vitro electrochemical characterization reveals that this coating significantly improves the corrosion resistance and mechanical integrity,and thus has the potential to greatly extend the related application field.

HVOF-sprayed HAp/S53P4 BG composite coatings on an AZ31 alloy for potential applications in temporary implants

Bioactive thermal spray coatings produced via high-velocity oxygen fuel spray(HVOF)from hydroxyapatite(HAp)and bioactive glasses(BG)have the potential to be employed on temporary implants due to the ability of both HAp and BG to dissolve and promote osseointegration,considering that both phases have different reaction and dissolution rates under in-vitro conditions.In the present work,75%wt.HAp-25%wt.S53P4 bioactive glass powders were HVOF-sprayed to obtain HAp/S53P4 BG composite coatings on a bioresorbable AZ31 alloy.The study is focused on exploring the effect of the stand-off distance and fuel/oxygen ratio variation as HVOF parameters to obtain stable structural coatings and to establish their effect on the phases and microstructure produced in those coatings.Different characterization techniques,such as scanning electron microscopy,X-ray diffraction,and Fourier transform infrared spectroscopy,were employed to characterize relevant structural and microstructural properties of the composite coatings.The results showed that thermal gradients during coating deposition must be managed to avoid delamination due to the high temperature achieved(max 550℃)and the differences in coefficients of thermal expansion.It was also found that both spraying distance and oxygen/fuel ratio allowed to keep the hydroxyapatite as the main phase in the coatings.In addition,in-vitro electrochemical studies were performed on the obtained HAp/S53P4 BG composite coatings and compared against the uncoated AZ31 alloy.The results showed a significant decrease in hydrogen evolution(at least 98%)when the bioactive coating was applied on the Mg alloy during evaluation in simulated body fluid(SBF).

Migration of a Progestin Implant into a Pulmonary Artery: Observation of a Case at the Reference Health Center of Commune III of the District of Bamako in Mali

It was a 36-year-old patient, 5th Pregnancy, 5th Delivery, 4 live children, and I deceased, had a consultation in the department for the removal of implants. Questioning revealed that she had had the implant three years ago without medical follow-up. It was in view of the difficulties in extracting the capsule that the chest X-ray and CT scan carried out concluded that the implant had migrated into a branch of the left pulmonary artery. Therapeutic abstention has been the attitude of cardiovascular surgeons.

Peri-implant gas accumulation in response to magnesium-based musculoskeletal biomaterials:Reframing current evidence for preclinical research and clinical evaluation

Historically,the rapid degradation and massive gas release from magnesium(Mg)implants resulted in severe emphysema and mechanical failure.With the advent of new alloys and surface treatment methods,optimized Mg implants have re-entered clinics since last decade with reliable performance.However,the optimization aims at slowing down the degradation process,rather than exemption of the gas release.This study involved a systematic evaluation of current preclinical and clinical evidence,regarding the physical signs,symptoms,radiological features,pathological findings and complications potentially associated with peri±implant gas accumulation(PIGA)after musculoskeletal Mg implantation.The literature search identified 196 potentially relevant publications,and 51 papers were enrolled for further analysis,including 22 preclinical tests and 29 clinical studies published from 2005 to 2023.Various Mg-based materials have been evaluated in animal research,and the application of pure Mg and Mg alloys have been reported in clinical follow-ups involving multiple anatomical sites and musculoskeletal disorders.Soft tissue and intraosseous PIGA are common in both animal tests and clinical follow-ups,and potentially associated with certain adverse events.Radiological examinations especially micro-CT and clinical CT scans provide valuable information for quantitative and longitudinal analysis.While according to simulation tests involving Mg implantation and chemical processing,tissue fixation could lead to an increase in the volume of gas cavity,thus the results obtained from ex vivo imaging or histopathological evaluations should be interpreted with caution.There still lacks standardized procedures or consensus for both preclinical and clinical evaluation of PIGA.However,by providing focused insights into the topic,this evidence-based study will facilitate future animal tests and clinical evaluations,and support developing biocompatible Mg implants for the treatment of musculoskeletal disorders.

Review on the Fabrication of Surface Functional Structures for Enhancing Bioactivity of Titanium and Titanium Alloy Implants

Titanium and its alloys have been widely applied in many biomedical fields because of its excellent mechanical properties,corrosion resistance and good biocompatibility.However,problems such as rejection,shedding and infection will occur after titanium alloy implantation due to the low biological activity of titanium alloy surface.The structures with specific functions,which can enhance osseointegration and antibacterial properties,are fabricated on the surface of titanium implants to improve the biological activity between the titanium implants and human tissues.This paper presents a comprehensive review of recent developments and applications of surface functional structure in titanium and titanium alloy implants.The applications of surface functional structure on different titanium and titanium alloy implants are introduced,and their manufacturing technologies are summarized and compared.Furthermore,the fabrication of various surface functional structures used for titanium and titanium alloy implants is reviewed and analyzed in detail.Finally,the challenges affecting the development of surface functional structures applied in titanium and titanium alloy implants are outlined,and recommendations for future research are presented.

Interfacial delivery of carbon monoxide via smart titanium implant coating for enhanced soft tissue integration with switchable antibacterial and immunomodulatory properties

Soft tissue integration around titanium(Ti)implants is weaker than that around natural teeth,compromising long-term success of Ti implants.Carbon monoxide(CO)possesses distinctive therapeutic properties,rendering it as a highly promising candidate for enhancing STI.However,achieving controlled CO generation at the STI interface remains challenging.Herein,a controlled CO-releasing dual-function coating was constructed on Ti surfaces.Under near-infrared(NIR)irradiation,the designed surface could actively accelerate CO generation for antibiosis against both aerobic and anaerobic bacteria.More importantly,in the absence of NIR,the slow release of CO induces macrophage polarization from pro-inflammatory phenotype towards pro-regenerative phenotype.In a rat implantation model with induced infection,the designed surface effectively controlled the bacterial infection,alleviates accompanying inflammation and modulated immune microenvironment,leading to enhanced STI.Single-cell sequencing revealed that the coating alters the cytokine profile within the soft tissue,thereby influencing cellular functions.Differentially expressed genes in macrophages are highly enriched in the PIK3-Akt pathway.Furthermore,the cellular communication between fibroblasts and macrophages was significantly enhanced through the CXCL12/CXCL14/CXCR4 and CSF1-CSF1R ligand-receptor pair.These findings indicate that our coating showed an appealing prospect for enhancing STI around Ti implants,which would ultimately contribute to the improved long-term success of Ti implants.

An overview of magnesium-based implants in orthopaedics and a prospect of its application in spine fusion

Due to matching biomechanical properties and significant biological activity,Mg-based implants present great potential in orthopedic applications.In recent years,the biocompatibility and therapeutic effect of magnesiumbased implants have been widely investigated in trauma repair.In contrast,the R&D work of Mg-based implants in spinal fusion is still limited.This review firstly introduced the general background for Mg-based implants.Secondly,the mechanical properties and degradation behaviors of Mg and its traditional and novel alloys were reviewed.Then,different surface modification techniques of Mg-based implants were described.Thirdly,this review comprehensively summarized the biological pathways of Mg degradation to promote bone formation in neuro-musculoskeletal circuit,angiogenesis with H-type vessel formation,osteogenesis with osteoblasts activation and chondrocyte ossification as an integrated system.Fourthly,this review followed the translation process of Mg-based implants via updating the preclinical studies in fracture fixation,sports trauma repair and reconstruction,and bone distraction for large bone defect.Furthermore,the pilot clinical studies were involved to demonstrate the reliable clinical safety and satisfactory bioactive effects of Mg-based implants in bone formation.Finally,this review introduced the background of spine fusion surgeryand the challenges of biological matching cage development.At last,this review prospected the translation potential of a hybrid Mg-PEEK spine fusion cage design.

Comparison between local-made and imported porous polyethylene orbital implant:a randomized controlled equivalence trial and multicenter study

AIM:To compare the exposure rate,infection rate,percentage of enhancement,and success rate between Medpor and the three-dimensional printed polyethylene(3DP-PE)orbital implant in a preliminary report.METHODS:This prospective,randomized,equivalence,controlled trial was conducted at two institutes.The equivalent margin was±10%.The sample size for the equivalence trial was 174 participants per group.Patients who were eligible for enucleations received either Medpor or 3DP-PE implants based on a randomized block of six.The surgeries were performed by five oculoplastic surgeons.The assessor and patients were masked.The magnetic resonance imaging(MRI)of the orbit was performed at least 6mo after operation and the fibrovascular ingrowth was analyzed using the Image J software.Follow-up continued at least 1y after surgery.The intention to treat and per protocol approaches were used.RESULTS:Totally 128 patients met the criteria in the report.Fifty Medpor and 553DP-PE cases completed the trial.The most common cause of blindness was trauma.The mean follow-up times of Medpor and 3DP-PE were 33 and 40mo respectively.The exposure rate was not statistically significant between two groups(6.0%and 7.3%),P<0.05,95%CI(-9.8%,+12.0%).The success rates were 94%(Medpor)and 92.7%(3DP-PE).No postoperative infection was reported.Nine patients had MRI tests and two had implant exposures with 66.3% enhancement at 75mo(Medpor)and 58% enhancement at 57mo(3DP-PE)postoperatively.CONCLUSION:There is no statistically significant difference in exposure rate and success rate between Medpor and 3DP-PE in enucleation in the report.However,we cannot conclude that they are equivalent in terms of the exposure rate and success rate because the 95%CI is wider than±10%.The infection rate is equivalent in both groups.