-
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 -
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 -
Journal of the American Academy of... Nov 2022The influence of sex on the failure of débridement antibiotics and implant retention (DAIR) for treating prosthetic joint infection (PJI) is important for... (Meta-Analysis)
Meta-Analysis
The Impact of Sex on the Outcomes of Prosthetic Joint Infection Treatment with Debridement, Antibiotics and Implant Retention: A Systematic Review and Individual Patient Data Meta-analysis.
BACKGROUND
The influence of sex on the failure of débridement antibiotics and implant retention (DAIR) for treating prosthetic joint infection (PJI) is important for decision-making, patient counseling, and equitable health care. However, very few studies in the orthopaedic literature conduct sex-specific analyses.
AIM
The primary aim was to determine whether sex influences treatment success after DAIR.
METHODS
A systematic review and individual patient data (IPD) meta-analysis was conducted. MEDLINE (Ovid), EMBASE (Ovid), Web of Science, and Google Scholar were searched, and IPD was requested via e-mail. Patients who underwent DAIR after developing PJI within 12 months of a primary total hip or knee arthroplasty were included in the analysis. Treatment failure was defined by the Delphi International Consensus criteria. Adjusted odds ratios for treatment failure were calculated using a mixed-effects logistic regression.
RESULTS
The study collected and analyzed IPD of 1,116 patients from 21 cohorts. The odds of treatment failure were 29% lower in women (odds ratio, 0.71; 95% CI 0.54 to 0.017; P = 0.017), after adjusting for duration of symptoms >7 days and Staphylococcus aureus infection (methicillin-susceptible Staphylococcus aureus or any infection with S aureus). None of the 64 studies included in the systematic review conducted a sex-specific analysis.
CONCLUSION
For patients who developed a PJI within 1 year postsurgery, females have lower odds of DAIR failure than males. Other factors also have varying effects on outcome for men and women. It is essential to implement sex-specific analysis in orthopaedic research.
Topics: Male; Humans; Female; Anti-Bacterial Agents; Debridement; Retrospective Studies; Prosthesis-Related Infections; Treatment Outcome; Staphylococcus aureus
PubMed: 36733983
DOI: 10.5435/JAAOSGlobal-D-22-00102 -
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 -
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 -
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 -
Revista Espanola de Cardiologia Jul 2004Antiproliferative drug-coated stents are a possible solution for post-angioplasty coronary restenosis. Here we analyze their efficacy, effectiveness and safety, and... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION AND OBJECTIVES
Antiproliferative drug-coated stents are a possible solution for post-angioplasty coronary restenosis. Here we analyze their efficacy, effectiveness and safety, and estimate the economic impact of their use in Spain.
MATERIAL AND METHOD
Systematic review (meta-analysis) of the scientific evidence available up to January 2004, and analysis of hospital costs within a 1-year time horizon.
RESULTS
We identified 12 published studies (5 clinical series and 7 RCTs) comparing coated stents (sirolimus or paclitaxel) with conventional stents in patient with de novo single lesions < 30 mm in 2.5-3.5 mm vessels. In nearly all cases the rates of angiographic restenosis and major adverse cardiac events were lower in the coated stent group after 6-12 months. Meta-analysis showed a 69% decrease in revascularization rate (RR=0.31; 95%CI, 0.19-0.51). For every 1000 patients with de novo lesions, the use of a coated stent involved an additional average cost of Euro 818718. The estimated neutral price of a new stent was Euro 1448 at a market price per unit of Euro 2000.
CONCLUSIONS
At 12-month follow-up, sirolimus- or paclitaxel-eluting stents were effective and safe in patients with de novo lesions and low or medium risk of restenosis. At current market prices, the widespread use of these stents would involve an increase in health care expenditure for the different sensitivity scenarios we evaluated. More studies are needed to specify the type of patients and lesions likely to obtain the greatest clinical benefit.
Topics: Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Stenosis; Cost-Benefit Analysis; Drug Delivery Systems; Drug Implants; Humans; Paclitaxel; Sirolimus; Spain; Stents
PubMed: 15274846
DOI: No ID Found -
The Cochrane Database of Systematic... Jul 2013Progestin-only contraceptives (POCs) are appropriate for many women who cannot or should not take estrogen. Many POCs are long-acting, cost-effective methods of... (Review)
Review
BACKGROUND
Progestin-only contraceptives (POCs) are appropriate for many women who cannot or should not take estrogen. Many POCs are long-acting, cost-effective methods of preventing pregnancy. However, concern about weight gain can deter the initiation of contraceptives and cause early discontinuation among users.
OBJECTIVES
The primary objective was to evaluate the association between progestin-only contraceptive use and changes in body weight.
SEARCH METHODS
Through May 2013, we searched MEDLINE, CENTRAL, POPLINE, LILACS, ClinicalTrials.gov, and ICTRP. The 2010 search also included EMBASE. For the initial review, we contacted investigators to identify other trials.
SELECTION CRITERIA
All comparative studies were eligible that examined a POC versus another contraceptive method or no contraceptive. The primary outcome was mean change in body weight or mean change in body composition. We also considered the dichotomous outcome of loss or gain of a specified amount of weight.
DATA COLLECTION AND ANALYSIS
Two authors extracted the data. We computed the mean difference (MD) with 95% confidence interval (CI) for continuous variables. For dichotomous outcomes, the Mantel-Haenszel odds ratio (OR) with 95% CI was calculated.
MAIN RESULTS
We found 16 studies; one examined progestin-only pills, one studied the levonorgestrel-releasing intrauterine system (LNG-IUS), four examined an implant, and 10 focused on depot medroxyprogesterone acetate (DMPA). Outcomes examined were changes in body weight only (14 studies), changes in both body weight and body composition (1 study), and changes in body composition only (1 study). We did not conduct meta-analysis due to the various contraceptive methods and weight change measures.Comparison groups did not differ significantly for weight change in 12 studies. However, three studies showed weight change differences for POC users compared to women not using a hormonal method. In one study, weight gain (kg) was greater for the DMPA group than the group using a non-hormonal IUD in years one through three [(MD 2.28; 95% CI 1.79 to 2.77), (MD 2.71, 95% CI 2.12 to 3.30), and (MD 3.17; 95% CI 2.51 to 3.83), respectively]. The differences were notable within the normal weight and overweight subgroups. Two implant studies also showed differences in weight change. The implant group (six-capsule) had greater weight gain (kg) compared to the group using a non-hormonal IUD in both studies [(MD 0.47 (95% CI 0.29 to 0.65); (MD 1.10; 95% CI 0.36 to 1.84)]. In one of those studies, the implant group also had greater weight gain than a group using a barrier method or no contraceptive (MD 0.74; 95% CI 0.52 to 0.96).The two studies that assessed body composition change showed differences between POC users and women not using a hormonal method. Adolescents using DMPA had a greater increase in body fat (%) compared to a group not using a hormonal method (MD 11.00; 95% CI 2.64 to 19.36). The DMPA group also had a greater decrease in lean body mass (%) (MD -4.00; 95% CI -6.93 to -1.07). The other study reported differences between an LNG-IUS group and a non-hormonal IUD group in percent change in body fat mass (2.5% versus -1.3%, respectively; reported P value = 0.029) and percent change in lean body mass (-1.4% versus 1.0%, respectively; reported P value = 0.027).
AUTHORS' CONCLUSIONS
The overall quality of evidence was moderate to low, given that the studies were evenly divided across the evidence quality groups (high, moderate, low, or very low quality). We found limited evidence of weight gain when using POCs. Mean gain was less than 2 kg for most studies up to 12 months. Weight change for the POC group generally did not differ significantly from that of the comparison group using another contraceptive. Two studies that assessed body composition showed that POC users had greater increases in body fat and decreases in lean body mass compared to users of non-hormonal methods. Appropriate counseling about typical weight gain may help reduce discontinuation of contraceptives due to perceptions of weight gain.
Topics: Body Composition; Body Weight; Contraceptives, Oral, Hormonal; Female; Humans; Levonorgestrel; Medroxyprogesterone Acetate; Progestins; Weight Gain
PubMed: 23821307
DOI: 10.1002/14651858.CD008815.pub3 -
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