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Breast (Edinburgh, Scotland) Feb 2021The impact of neoadjuvant chemotherapy (NACT) on surgical outcomes following immediate breast reconstruction (IBR) remains unclear. While it is generally considered safe... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The impact of neoadjuvant chemotherapy (NACT) on surgical outcomes following immediate breast reconstruction (IBR) remains unclear. While it is generally considered safe practice to perform an IBR post NACT, reported complication rates in published data are highly variable with the majority of studies including fewer than 50 patients in the NACT and IBR arm. To evaluate this further, we conducted a systematic review and meta-analysis on the effect of NACT on autologous and implant based immediate breast reconstructions. We aimed to assess for differences in the post-operative course following IBR between patients who received NACT with those who did not.
METHODS
PubMed, EMBASE, and Cochrane Library were searched from 1995 to Sept 2, 2020 to identify articles that assessed the impact of NACT on IBR. All included studies assessed outcomes following IBR. Only studies comparing reconstructed patients receiving NACT to a control group of women who did not receive NACT were included. Unadjusted relative risk of outcomes between patients who received or did not receive NACT were synthesized using a fixed-effect meta-analysis. The evidence was assessed using the Newcastle Ottawa Scale scores and GRADE. Primary effect measures were risk ratios (RRs) with 95% confidence intervals.
RESULTS
A total 17 studies comprising 3249 patients were included in the meta-analyses. Overall, NACT did not increase the risk of complications after immediate breast reconstructions (risk ratio [RR]: 0.91, 95% CI 0.74 to 1.11, p = 0.34). There was a moderate, but not significant, increase in flap loss following NACT compared with controls (RR: 1.23, 95% CI 0.70 to 2.18, p = 0.47; I = 0%). Most notably, there was a statistically significant increase in implant/expander loss after NACT (RR: 1.54, 95% CI 1.04 to 2.29, p = 0.03; I = 34%). NACT was not shown to significantly increase the incidence of hematomas, seromas or wound complications, or result in a significant delay to commencing adjuvant therapy (RR: 1.59, 95% CI 0.66 to 3.87, p = 0.30).
CONCLUSION
Immediate breast reconstruction after NACT is a safe procedure with an acceptable post-operative complication profile. It may result in a slight increase in implant loss rates, but it does not delay commencing adjuvant therapy.
Topics: Breast Neoplasms; Chemotherapy, Adjuvant; Combined Modality Therapy; Female; Humans; Mammaplasty; Neoadjuvant Therapy; Postoperative Complications
PubMed: 33341706
DOI: 10.1016/j.breast.2020.11.023 -
Journal of Biomaterials Applications Feb 2020Medical devices made of polydioxanone (a synthetic biodegradable polymer) have been available since the early 1980s. However, no review regarding their performance and...
BACKGROUND
Medical devices made of polydioxanone (a synthetic biodegradable polymer) have been available since the early 1980s. However, no review regarding their performance and safety has been published.
OBJECTIVE
This systematic review intends to review and assess commercially available polydioxanone implants and their safety and performance in patients.
METHODS
We searched for approved polydioxanone implants in several Food and Drug Administration databases. Then, we performed a literature search for publications and clinical trials where polydioxanone devices were implanted in patients. This search was performed on MEDLINE, Embase, Scopus and other databases. Safety and performance of polydioxanone implants in patients were assessed and compared with the implantation of non-polydioxanone devices, when possible, based on scoring systems developed by the authors that analyse surgical site infection rates, inflammatory reaction rates, foreign body response, postoperative pain and fever.
RESULTS
Food and Drug Administration databases search revealed that 48 implants have been approved since 1981, with 1294 adverse reactions or product malfunction in the last decade and 16 recalls. A total of 49 clinical trials and 104 scientific publications were found. Polydioxanone sutures and meshes/plates had low rates of surgical site infection, inflammatory reaction, foreign body response and postoperative fever. Polydioxanone clips/staples reported high rates of surgical site infection, postoperative fever and pain, with sub-optimal clinical performance and poor safety rates. The remaining implants identified showed high levels of safety and performance. Safety scores of polydioxanone implants and non-polydioxanone alternatives are similar. Polydioxanone monofilament sutures perform better than non-polydioxanone alternatives but performance did not differ with remaining polydioxanone implant types.
CONCLUSIONS
Although polydioxanone clips/staples should be implanted with caution and monitored carefully, in general, safety and performance scores of other polydioxanone implants did not differ from non-polydioxanone alternatives. This review will be a useful reference for researchers and industries developing new polydioxanone medical devices.
Topics: Absorbable Implants; Biocompatible Materials; Device Approval; Humans; Inflammation; Medical Device Recalls; Polydioxanone
PubMed: 31771403
DOI: 10.1177/0885328219888841 -
Journal of Dentistry (Shiraz, Iran) Sep 2022Bone morphogenetic protein (BMP), a potential osteoinductive agent, was systematically reviewed for merits and demerits when used as a bone additive that was intervened...
STATEMENT OF THE PROBLEM
Bone morphogenetic protein (BMP), a potential osteoinductive agent, was systematically reviewed for merits and demerits when used as a bone additive that was intervened during the surgical phase of dental implant placement; and suitable drug carriers that could withstand the functional load and deliver BMP at its lowest concentration.
PURPOSE
To identify the carriers and concentration of BMP acceptable during surgical phase of implant placement and evaluate its efficacy in bone gain and osseointegration.
MATERIALS AND METHOD
The study design was systematic review. Literature search as per PICO format was carried out within a time range from 2000 to July 2021. The review fol-lowed PRISMA guidelines and registered with the PROSPERO (CRD42020171667). The focus question included the population with an intra-oral implant placed in both animal and human models that were intervened with BMP-2 as an external additive biomaterial during the surgical phase. 2631 articles selected from the initial search were systematically filtered and yielded 16 articles that were qualitatively analysed.
RESULTS
The inter-rater reliability and level of agreement were 93.71%, κ(Kappa)>0.81 re-spectively. Results revealed the collagen carrier was commonly used for BMP delivery but lacked the property to withstand functional load and sustained release. BMP concentration varied in the range of 0.215μg to 0.8mg and the study revealed significantly indifferent out-come with low dose compared to the highest dose. BMP supplement showed better osseointe-gration in comparison with non-supplemented sites during the early period (within 6 months).
CONCLUSION
BMP at lower concentrations and with appropriate carriers, collagen sponge, hydroxyapatite/tricalcium phosphate (HA/TCP) with a bio ceramic bulking agent, and poly (D, L-lactide-co-glycolic acid) (PLGA) reinforced with gelatin/HA/TCP accelerated bone growth during the initial stages of healing. Further long-term clinical trials for dental implant, analysing the sustained release of BMP with biodegradable and load-bearing carriers should be considered.
PubMed: 36588970
DOI: 10.30476/DENTJODS.2021.90931.1536 -
Laryngoscope Investigative... Jun 2024To establish audiological and other outcomes following cochlear implantation in humans and animals with eluting electrodes. (Review)
Review
OBJECTIVES
To establish audiological and other outcomes following cochlear implantation in humans and animals with eluting electrodes.
METHODS
Systematic review and narrative synthesis. Databases searched (April 2023): MEDLINE, EMBASE, CENTRAL, ClinicalTrials.gov, and Web of Science. Studies reporting outcomes in either humans or animals following cochlear implantation with a drug-eluting electrode were included. No limits were placed on language or year of publication. Risk of bias assessment was performed on all included studies using either the Brazzelli or Systematic Review Centre for Laboratory animal Experimentation (SYRCLE) assessment tools. The review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 statement.
RESULTS
Searches identified 146 abstracts and 108 full texts. Of these, 18 studies met the inclusion criteria, reporting outcomes in 523 animals (17 studies) and 24 humans (1 study). Eluting electrodes included dexamethasone (16 studies), aracytine (1 study), nicotinamide adenine dinucleotide (1 study), the growth factors insulin-like growth factor 1 (IGF1) and hepatocyte growth factor (HGF) (1 study), and neurotrophin-3 (1 study). All included studies compare outcomes following implantation with an eluting electrode with a control non-eluting electrode. In the majority of studies, audiological outcomes (e.g., auditory brainstem response threshold) were superior following implantation with an eluting electrode compared with a standard electrode. Most studies which investigated post-implantation impedance reported lower impedance following implantation with an eluting electrode. The influence of eluting electrodes on other reported outcomes (including post-implantation cochlear fibrosis and the survival of hair cells and spiral ganglion neurons) was more varied across the included studies.
CONCLUSIONS
Eluting electrodes have shown promise in animal studies in preserving residual hearing following cochlear implantation and in reducing impedance, though data from human studies remain lacking. Further in-human studies will be required to determine the clinical usefulness of drug-eluting cochlear implants as a future treatment for sensorineural hearing loss.
PubMed: 38855776
DOI: 10.1002/lio2.1263 -
Frontiers in Pharmacology 2022To compare the efficacy and safety of advanced intravitreal therapeutic regimens, including a dexamethasone implant at 350 and 700 μg; a fluocinolone acetonide (FA)...
To compare the efficacy and safety of advanced intravitreal therapeutic regimens, including a dexamethasone implant at 350 and 700 μg; a fluocinolone acetonide (FA) implant, 0.2 µg/day, 0.59 and 2.1 mg; intravitreal bevacizumab, 1.25 mg; intravitreal ranibizumab, 0.5 mg; intravitreal triamcinolone acetonide (IVTA), 2 and 4 mg; and standard of care (SOC, systemic therapy) for noninfectious uveitis. We searched the Cochrane Library database, EMBASE, Medline, clinicaltrials.gov until April 2021 with 13 RCTs (1806 participants) identified and conducted a pairwise and Bayesian network meta-analysis with random effects. No specific regimen showed a statistically significant advantage or disadvantage to another treatment regimen with regard to efficacy. However, the FA implant, 0.59 mg was associated with a higher risk of cataract (RR 4.41, 95% CI 1.51-13.13) and raise in intraocular pressure (IOP) (RR 2.53 95% CI 1.14-6.25) compared with SOC at 24 months. IVTA, 4 mg at 6 months was associated with lower risk of IOP rising compared with FA implant, 0.2 µg/day at 36 months (RR 3.43 95% CI 1.12-11.35). No intravitreal therapeutic regimens showed a significant advantage or disadvantage with regard to efficacy. However, SOC was associated with lower risk of side effects compared with FA implants. IVTA, 4 mg, might be the best choice with lowest risk of IOP rising. clinicaltrials.gov, identifier CRD42020172953.
PubMed: 35450045
DOI: 10.3389/fphar.2022.749312 -
PloS One 2021In 2002 a pyrocarbon interphalangeal joint implant was granted Food and Drug Administration approval with limited evidence of effectiveness. It is important to... (Meta-Analysis)
Meta-Analysis
BACKGROUND
In 2002 a pyrocarbon interphalangeal joint implant was granted Food and Drug Administration approval with limited evidence of effectiveness. It is important to understand device use and outcomes since this implant entered clinical practice in order to establish incremental evidence, appropriate study design and reporting. This systematic review summarised and appraised studies reporting pyrocarbon proximal interphalangeal joint arthroplasty.
METHODS
Systematic review of MEDLINE, EMBASE, SCOPUS, Web of Science, BIOSIS, CINAHL and CENTRAL from inception to November 2020. All study designs reporting pyrocarbon proximal interphalangeal joint arthroplasty in humans were included. Data extracted included information about study characteristics, patient selection, regulatory (gaining research ethics approval) and governance issues (reporting of conflicting interests), operator and centre experience, technique description and outcome reporting. Descriptive and narrative summaries were reported.
RESULTS
From 4316 abstracts, 210 full-text articles were screened. A total of 38 studies and 1434 (1-184) patients were included. These consisted of three case reports, 24 case series, 10 retrospective cohort studies and one randomised trial. Inclusion and exclusion criteria were stated in 25 (66%) studies. Most studies (n = 27, 71%) gained research ethics approval to be conducted. Six studies reported conflicting interests. Experience of operating surgeons was reported in nine (24%) and caseload volume in five studies. There was no consensus about the optimal surgical approach. Technical aspects of implant placement were reported frequently (n = 32) but the detail provided varied widely. Studies reported multiple, heterogenous outcomes. The most commonly reported outcome was range of motion (n = 37).
CONCLUSIONS
This systematic review identified inconsistencies in how studies describing the early use and update of an innovative procedure were reported. Incremental evidence was lacking, risking the implant being adopted without robust evaluation. This review adds to evidence highlighting the need for more rigorous evaluation of how implantable medical devices are used in practice following licencing.
Topics: Arthroplasty; Biocompatible Materials; Carbon; Evaluation Studies as Topic; Humans; Joint Prosthesis; Medical Device Legislation; Patient Selection
PubMed: 34665802
DOI: 10.1371/journal.pone.0257497 -
International Journal of Implant... Jul 2018The literature states that Strontium (Sr) is able to simultaneously stimulate bone formation and suppress bone resorption. Recent animal studies suggest that the... (Review)
Review
The literature states that Strontium (Sr) is able to simultaneously stimulate bone formation and suppress bone resorption. Recent animal studies suggest that the systemic administration of Sr, in the form of strontium ranelate (SRAN), would enhance the osseointegration of implants. The purpose of the present study was to undertake a systematic review on animal studies evaluating the systemic administration of Sr to enhance the osseointegration of titanium implants and the remodeling of bone grafts. The MEDLINE (PubMed) and Scopus bibliographic databases were searched from 1950 to October 2017 for reports on the use of systemic and non-radioactive Sr to enhance the osseointegration of titanium implants and the remodeling of bone grafts in animals. The search strategy was restricted to English language publications using the combined terms: "strontium" and "implant or graft or biomaterial or bone substitute". Five studies were included, all related to the systemic administration of Sr in the form SRAN, and its effects on osseointegration of titanium implants. No studies on the use of SRAN-based therapy to enhance the remodeling of bone grafts were found. The studies differed notably with respect to the study population (healthy female rats, healthy male rats, and female rats with induced osteoporosis) and SRAN dose (ranging from 500 to 1000 mg/kg/day). Results were diverse, but a tendency suggesting positive influence of systemic SRAN administration on the osseointegration of titanium implants was observed. No major side-effects due to strontium administration were reported. Systemic Sr administration, in the form of SRAN, seems to enhance peri-implant bone quality and implant osseointegration in animals, however, at a moderate extent. Further studies, evaluating both the effects of this drug on implant osseointegration and the risk/benefit of its use, are needed to provide a rationale of this therapeutic approach.
PubMed: 30014305
DOI: 10.1186/s40729-018-0132-8 -
Medicina Oral, Patologia Oral Y Cirugia... Mar 2019The aim of this study was to determine if the treatment with bisphosphonates other anti-resorptive and antiangiogenic agents influences the success of regenerative and /...
BACKGROUND
The aim of this study was to determine if the treatment with bisphosphonates other anti-resorptive and antiangiogenic agents influences the success of regenerative and / or implant treatments.
MATERIAL AND METHODS
We reviewed the literature from the last 5 years in the PubMed database, using the following words: "Sinus Floor Augmentation"[Mesh] OR "Dental Implants"[Mesh]) OR "Guided Tissue Regeneration"[Mesh]) AND "Osteonecrosis"[Mesh]. The articles were selected following the inclusion and exclusion criteria and were evaluated using the 22 items of the STROBE declaration. The following PICO clinical question was applied: Does the treatment with agents associated with drug osteonecrosis influence the success of regenerative and implant treatments?
RESULTS
The initial search resulted in a total of 27 articles. After eliminating those that did not refer to the topic, were duplicated or did not meet the inclusion / exclusion criteria, a full reading of the articles was made evaluating their methodological quality, obtaining six studies with high methodological quality and two with moderate.
CONCLUSIONS
The literature regarding this topic is scarce, randomized clinical trials would be necessary to establish protocols relative to implant treatment in patients on antiresorptive treatments. The risk of developing an osteonecrosis associated with the regeneration / implant placement in patients with benign bone diseases is scarce, but it exists and it should not be underestimated. Especially, in the posterior areas of the jaw, if the duration of treatment with BP is greater than 3 years, and if the patient is under therapy with systemic corticosteroids.
Topics: Animals; Antibodies, Monoclonal; Bone Regeneration; Databases, Factual; Dental Implantation, Endosseous; Dental Implants; Dental Restoration Failure; Diphosphonates; Drug Antagonism; Humans; Osteonecrosis; Sinus Floor Augmentation
PubMed: 30818312
DOI: 10.4317/medoral.22691 -
Orthopaedics & Traumatology, Surgery &... Apr 2023Atypical periprosthetic/peri-implant fractures are not recognised in any widely used classification and therefore little focus is given to them. Multiple case reports... (Meta-Analysis)
Meta-Analysis
Is bisphosphonate use a risk factor for atypical periprosthetic/peri-implant fractures? - A metanalysis of retrospective cohort studies and systematic review of the current evidence.
INTRODUCTION
Atypical periprosthetic/peri-implant fractures are not recognised in any widely used classification and therefore little focus is given to them. Multiple case reports and case series demonstrate these fractures exist and are related to bisphosphonate (BP) use.
HYPOTHESIS
Are patients taking long-term BPs at an increased risk of developing an atypical periprosthetic/peri-implant fracture? Is a particular BP drug causing an increased risk of fracture? Is there a correlation between the time of BP use and the incidence of fractures? Do vitamin D analogues or parathyroid hormones reduce the time to union?
MATERIAL AND METHODS
Systematic review of all available evidence on the existence of periprosthetic/peri-implant atypical fractures in patients taking long-term BPs and metanalysis of available retrospective cohort studies. Selected 1 systematic review, 7 retrospective cohort studies (5 used for metanalysis) and 32 case reports.
RESULTS
Metanalysis reported a risk ratio of 14.1, p=0.25, suggesting bisphosphonates are a risk factor in the development of periprosthetic/peri-implant atypical fractures. The secondary outcomes couldn't be reliably identified due to the small size of available studies and risk of significant bias.
DISCUSSION
Atypical periprosthetic/peri-implant fractures are an entity and seem to be associated with the use of bisphosphonates. The benefits of bisphosphonates use outweigh the risks, but clinicians should be aware of atypical fractures and actively search for them when patients on long-term bisphosphonates attend with non-specific pain close to the implant/prosthesis or reduced mobility.
LEVEL OF EVIDENCE
II, Systematic review and metanalysis.
Topics: Humans; Diphosphonates; Femoral Fractures; Periprosthetic Fractures; Retrospective Studies; Risk Factors
PubMed: 36347461
DOI: 10.1016/j.otsr.2022.103475 -
Frontiers in Cellular and Infection... 2023Peri-implant diseases are pathological conditions that affect the survival of dental implants. Etiological studies are limited, accepting a prevalence of 20% at the... (Meta-Analysis)
Meta-Analysis Review
Peri-implant diseases are pathological conditions that affect the survival of dental implants. Etiological studies are limited, accepting a prevalence of 20% at the implant level and 24% at the patient level. The benefits of adjuvant metronidazole are controversial. A systematic review and meta-analysis of RCTs according to PRISMA and PICOS was performed with an electronic search over the last 10 years in MEDLINE (PubMed), WOS, Embase, and Cochrane Library. The risk of bias was measured using the Cochrane Risk of Bias tool and the methodological quality using the Jadad scale. Meta-analysis was performed with RevMan version 5.4.1, based on mean difference and standard deviation, with 95% confidence intervals; the random-effects model was selected, and the threshold for statistical significance was defined as < 0.05. A total of 38 studies were collected and five were selected. Finally, one of the studies was eliminated because of unanalyzable results. All studies reached a high methodological quality. A total of 289 patients were studied with follow-up periods from 2 weeks to 1 year. Statistical significance was only found, with respect to the use of adjunctive metronidazole, in the pooled analysis of the studies ( = 0.02) and in the analysis of the radiographic values reported on peri-implant marginal bone levels, in the studies with a 3-month follow-up ( = 0.03). Discrepancies in the use of systemic metronidazole require long-term randomized clinical trials (RCTs) to determine the role of antibiotics in the treatment of peri-implantitis.
Topics: Humans; Peri-Implantitis; Metronidazole; Anti-Bacterial Agents; Combined Modality Therapy; Bias
PubMed: 37287463
DOI: 10.3389/fcimb.2023.1149055