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Frontiers in Rehabilitation Sciences 2024Bone-anchored prostheses (BAP) are an advanced reconstructive surgical approach for individuals who had transfemoral amputation and are unable to use the conventional...
INTRODUCTION
Bone-anchored prostheses (BAP) are an advanced reconstructive surgical approach for individuals who had transfemoral amputation and are unable to use the conventional socket-suspension systems for their prostheses. Access to this technology has been limited in part due to the lag between the start of a new procedure and the availability of evidence that is required before making decisions about widespread provision. This systematic review presents as a single resource up-to-date information on aspects most relevant to decision makers, i.e., clinical efficacy, safety parameters, patient experiences, and health economic outcomes of this technology.
METHODS
A systematic search of the literature was conducted by an information specialist in PubMed, MEDLINE, Embase, CINAHL, Cochrane Library, the Core Collection of Web of Science, CADTH's Grey Matters, and Google Scholar up until May 31, 2023. Peer-reviewed original research articles on the outcomes of clinical effectiveness (health-related quality of life, mobility, and prosthesis usage), complications and adverse events, patient experiences, and health economic outcomes were included. The quality of the studies was assessed using the Oxford Centre for Evidence-Based Medicine Levels of Evidence and ROBINS-I, as appropriate.
RESULTS
Fifty studies met the inclusion criteria, of which 12 were excluded. Thirty-eight studies were finally included in this review, of which 21 reported on clinical outcomes and complications, 9 case series and 1 cohort study focused specifically on complications and adverse events, and 2 and 5 qualitative studies reported on patient experience and health economic assessments, respectively. The most common study design is a single-arm trial (pre-/post-intervention design) with varying lengths of follow-up.
DISCUSSION
The clinical efficacy of this technology is evident in selected populations. Overall, patients reported increased health-related quality of life, mobility, and prosthesis usage post-intervention. The most common complication is a superficial or soft-tissue infection, and more serious complications are rare. Patient-reported experiences have generally been positive. Evidence indicates that bone-anchored implants for prosthesis fixation are cost-effective for those individuals who face significant challenges in using socket-suspension systems, although they may offer no additional advantage to those who are functioning well with their socket-suspended prostheses.
PubMed: 38628292
DOI: 10.3389/fresc.2024.1336042 -
Advances in Wound Care Apr 2024The meta-analysis was performed to evaluate the effectiveness of telemedicine interventions on patients with diabetic foot ulcers(DFU).
OBJECTIVE
The meta-analysis was performed to evaluate the effectiveness of telemedicine interventions on patients with diabetic foot ulcers(DFU).
APPROACH
The authors conducted a comprehensive search across eight databases. The aim was to identify randomized controlled trials examining the effectiveness of telemedicine for patients with DFU. Methodological qualities of included studies were assessed using Cochrane Handbook for Systematic Reviews of Intervention.. Subsequently, a meta-analysis was conducted using RevMan 5.3 to synthesize the findings.
RESULTS
Ten studies involving 1678 patients with DFU were included in the meta-analysis. In comparison to the face-to-face intervention group, telemedicine interventions significantly reduced the amputation rate (risk ratio (RR) = 0.64, 95% confidence interval (CI) = 0.44-0.92, p = 0.02), decreased costs (mean difference (MD) = -4158.51, 95% CI = -7304.69--1012.34, p = 0.01), better controlled fasting blood glucose( FPG)(MD = -0.89, 95% CI = -1.43--0.36, p = 0.001), achieved superior glycated hemoglobin(HbA1c) control (MD = -0.71, 95% CI = -1.01--0.41, p ˂ 0.00001). No significant differences were observed between the telemedicine group and the face-to-face group in terms of healing rate, mortality, and healing time. Innovations: Our study suggests that telemedicine is a viable strategy for managing DFU.
CONCLUSIONS
The meta-analysis indicates that telemedicine interventions have a positive effect on DFU. Nevertheless, more well-designed and high-quality studies are needed to reach a conclusion with greater confidence.
PubMed: 38618714
DOI: 10.1089/wound.2024.0030 -
Healthcare (Basel, Switzerland) Apr 2024The aim of this systematic review was to investigate the outcomes of knee arthrodesis (KA) after periprosthetic joint infection (PJI) of the knee. Differences in... (Review)
Review
The aim of this systematic review was to investigate the outcomes of knee arthrodesis (KA) after periprosthetic joint infection (PJI) of the knee. Differences in clinical outcomes and complication rates among the intramedullary nailing (IMN), external fixation (EF), and compression plating (CP) procedures were compared. A total of 23 studies were included. Demographics, microbiological data, types of implants, surgical techniques with complications, reoperations, fusion, and amputation rates were reported. A total of 787 patients were evaluated, of whom 601 (76.4%), 166 (21%), and 19 (2.4%) underwent IMN, EF, and CP, respectively. The most common causative pathogen was (). Fusion occurred in 71.9%, 78.8%, and 92.3% of the patients after IMN, EF, and CP, respectively, and no statistically significant difference was found. Reinfection rates were 14.6%, 15.1%, and 10.5% after IMN, EF, and CP, respectively, and no statistically significant difference was found. Conversion to amputation occurred in 4.3%, 5%, and 15.8% of patients after IMN, EF, and CP, respectively; there was a higher rate after CP than after EF. The IMN technique is the most common option used for managing PJI with KA. No differences in terms of fusion, reinfection, or conversion-to-amputation rates were reported between IMN and EF. CP is rarely used, and the high amputation rate represents an important limitation of this technique.
PubMed: 38610226
DOI: 10.3390/healthcare12070804 -
Journal of Plastic, Reconstructive &... May 2024Globally, over 1 million lower limb amputations are performed annually, with approximately 75% of patients experiencing significant pain, profoundly impacting their... (Review)
Review
BACKGROUND
Globally, over 1 million lower limb amputations are performed annually, with approximately 75% of patients experiencing significant pain, profoundly impacting their quality of life and functional capabilities. Targeted muscle reinnervation (TMR) has emerged as a surgical solution involving the rerouting of amputated nerves to specific muscle targets. Originally introduced to enhance signal amplification for myoelectric prosthesis control, TMR has expanded its applications to include neuroma management and pain relief. However, the literature assessing patient outcomes is lacking, specifically for lower limb amputees. This systematic review aims to assess the effectiveness of TMR in reducing pain and enhancing functional outcomes for patients who have undergone lower limb amputation.
METHODS
A systematic review was performed by examining relevant studies between 2010 and 2023, focusing on pain reduction, functional outcomes and patient-reported quality of life measures.
RESULTS
In total, 20 studies were eligible encompassing a total of 778 extremities, of which 75.06% (n = 584) were lower limb amputees. Average age was 46.66 years and patients were predominantly male (n = 70.67%). Seven studies (35%) reported functional outcomes. Patients who underwent primary TMR exhibited lower average patient-reported outcome measurement information system (PROMIS) scores for phantom limb pain (PLP) and residual limb pain (RLP). Secondary TMR led to improvements in PLP, RLP and general limb pain as indicated by average numeric rating scale and PROMIS scores.
CONCLUSION
The systematic review underscores TMR's potential benefits in alleviating pain, fostering post-amputation rehabilitation and enhancing overall well-being for lower limb amputees.
Topics: Humans; Quality of Life; Amputation, Surgical; Lower Extremity; Nerve Transfer; Muscle, Skeletal; Phantom Limb; Patient Reported Outcome Measures; Pain Management; Amputees
PubMed: 38599000
DOI: 10.1016/j.bjps.2024.03.013 -
Journal of Tissue Viability May 2024A systematic review was conducted to evaluate the time delays in the management of diabetic foot and explore influencing factors of these delays and potential outcomes. (Review)
Review
OBJECTIVE
A systematic review was conducted to evaluate the time delays in the management of diabetic foot and explore influencing factors of these delays and potential outcomes.
METHODS
The researchers searched several electronic databases (Pubmed, Web of Science, Cochrane Library, EMbase, CNKI, WanFang, CBM and VIP) for English and Chinese studies that examined time delays in the management pathway of diabetic foot. Two authors independently screened and extracted data, and assessed the quality of the included studies using the Newcastle-Ottawa Scale and the Agency for Health Research and Quality checklist. Due to heterogeneity among the studies, descriptive analysis was performed.
RESULTS
The review included 28 articles, comprising 20 cohort studies and 8 cross-sectional studies, that met the inclusion criteria. Among these, 14 were deemed of high quality. The median times from symptom onset to primary health care or specialist care varied from 3 to 46.69 days. The median delay in referral by primary care specialists ranged from 7 to 31 days, and subsequent median times to definitive treatment ranged from 6.2 to 56 days. Multiple complex factors were found to contribute to these delays, including patient demographics (older age, lower education level and income level) and poor patient health-seeking behaviors (inaccurate self-treatment, incorrect recognition and interpretation of symptoms), inaccurate assessment or initial treatment by health primary professionals, complex referral pathways and clinical characteristics of diabetic foot (number of foot ulcers, Wagner grade scale, and hemoglobin A1c index). Negative outcomes associated with these delays included increased risk of major amputation and mortality, decreased wound healing rate, prolonged hospital stay, and increased hospital costs.
CONCLUSIONS
Time delays in the diabetic foot management pathway were both common and serious, contributing to negative health outcomes for patients with diabetic foot. Many complex factors related to patient's poor patient health-seeking behaviors, health system, and clinical characteristics of diabetic foot are responsible for these delays. Therefore, it is necessary to develop new strategies for standard referral practices and strengthen patient awareness of seeking care.
Topics: Humans; Diabetic Foot; Time Factors; Time-to-Treatment
PubMed: 38594149
DOI: 10.1016/j.jtv.2024.04.007 -
Journal of Endovascular Therapy : An... Apr 2024The purpose of this study is to assess the efficacy and safety of cilostazol prescription in patients with femoropopliteal peripheral artery disease (PAD) after... (Review)
Review
A Systematic Review and Meta-Analysis of Efficacy and Safety of Cilostazol Prescription in Patients With Femoropopliteal Peripheral Artery Disease After Endovascular Therapy.
PURPOSE
The purpose of this study is to assess the efficacy and safety of cilostazol prescription in patients with femoropopliteal peripheral artery disease (PAD) after endovascular therapy (EVT).
MATERIALS AND METHODS
We conducted a systematic review and meta-analysis of all studies reporting the outcomes of cilostazol after femoropopliteal EVT of PAD up to September 2022. Clinical outcomes of interest included primary patency, in-stent restenosis (ISR), vessel re-occlusion, freedom from target lesion revascularization (TLR), repeat revascularization, all-cause mortality, amputation, major adverse cardiovascular events (MACEs) and major adverse limb events (MALEs), and bleeding complication.
RESULTS
A total of 4 randomized controlled trials (RCTs) and 8 observational studies containing a total of 4898 patients met the inclusion criteria and were included in this systematic review and meta-analysis. We found that the use of cilostazol was associated with higher primary patency after femoropopliteal artery EVT (odds ratio [OR]=1.67, 95% confidence interval [CI]=1.50-1.87, p<0.001, I=33.2%), a lower risk of ISR (OR=0.43, 95% CI=0.29-0.63, p<0.001, I=37.6%), repeat revascularization (OR=0.43, 95% CI=0.24-0.76, p<0.005, I=27.4%), and vessel re-occlusion (OR=0.59, 95% CI=0.38-0.93, p<0.05, I=0%). There was an increase in freedom from TLR rate (OR=2.19, 95% CI=1.58-3.05, p<0.001, I=0%), as well as a reduction in the occurrence of MALEs (OR=0.50, 95% CI=0.29-0.85, p<0.05, I=0%). However, there was no significant difference in amputation, MACEs, all-cause mortality, and major bleeding complications. Subgroup analysis showed that cilostazol treatment in patients with femoropopliteal drug-eluting stents (DES) implantation remained associated with higher primary patency and a lower risk of ISR.
CONCLUSIONS
After EVT of femoropopliteal artery lesions, additional oral cilostazol enhances primary patency, reduces the occurrences of ISR and vessel re-occlusion, diminishes the risks associated with MALEs, lowers the need for repeat revascularization, and increases freedom from TLR rates. However, it does not impact amputation, MACEs, all-cause mortality, or major bleeding complications. These findings suggest cilostazol as a potentially safe and effective adjunct therapy in patients with femoropopliteal PAD after EVT.
CLINICAL IMPACT
After undergoing endovascular therapy (EVT) for femoropopliteal artery lesions, the addition of cilostazol to antiplatelet therapy can significantly improve primary patency, reducing the incidence of in-stent restenosis, repeat revascularization, vessel re-occlusion, and major adverse limb events while increasing freedom from target lesion revascularization rate. The simultaneous use of drug-eluting stents in the femoropopliteal artery lesions, combined with cilostazol, potentially results in a synergistic anti-stenotic effect. This therapeutic approach does not appear to be associated with an increased risk of major bleeding events or all-cause mortality. These findings provide additional evidence supporting the treatment of anti-stenosis in patients with femoropopliteal artery lesions after EVT.
PubMed: 38590247
DOI: 10.1177/15266028241241248 -
Annals of Vascular Surgery Aug 2024Heparin-bonded expanded polytetrafluoroethylene (hb-ePTFE) synthetic grafts are an alternative to autologous vein grafts (AVG) for surgical bypass interventions in lower... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Heparin-bonded expanded polytetrafluoroethylene (hb-ePTFE) synthetic grafts are an alternative to autologous vein grafts (AVG) for surgical bypass interventions in lower limb peripheral arterial disease (LLPAD). However, the clinical benefits of hb-ePTFE grafts have not been reviewed systematically for patients undergoing below-the-knee (BK) surgical bypass. This study aimed to meta-analyze available data on the utility of hb-ePTFE in patients undergoing BK surgical bypass.
METHODS
Medline, Embase, and Cochrane databases were searched, restricted to material in English with no date restriction. In addition, proceedings from relevant congresses were screened going back 2 years. The search was performed in December 2021. Eligible studies included prospective or retrospective comparative studies or prospective single-arm cohorts with an hb-ePTFE arm. Methodological quality was assessed with the ROBINS-I criteria. Outcomes included primary patency, amputation/limb salvage, and overall survival. Clinical outcomes were expressed as event rates. Studies were compared using meta-analysis to generate a standardized mean event rate for each outcome, with its 95% confidence interval (95% CI), using a random-effects model.
RESULTS
Following deduplication, 10,263 records were identified and 261 were assessed as full texts. No prospective comparative studies were identified. The level of evidence was uniformly low. Seventeen publications describing data from 9 individual patient cohorts met the inclusion criteria. These cohorts included a total of 1,452 patients undergoing BK surgical bypass with hb-ePTFE. The primary patency rate was 78.9% [95% CI: 72.2-85.7%] at 1 year, 68.2% [95% CI: 62.8-73.6%] at 2 years, decreasing to 48.0% [95% CI: 27.3-68.7%] at 5 years. The secondary patency rate was 84.8% [95% CI: 77.0-92.5%] at 1 year and 68.9% [95% CI: 43.0-94.9%] at 3 years; the 1-year limb salvage rate was 88.3% [95% CI: 79.6-97.1%] at 1 year and 79.0% [95% CI: 56.7-100%] at 3 years.
CONCLUSIONS
In patients undergoing BK bypass surgery, hb-ePTFE synthetic grafts, compared to uncoated grafts, perform well for patency and limb salvage. However, the quality of the evidence is low, and well-performed randomized clinical trials are needed to inform clinical decision-making on the choice of synthetic graft.
Topics: Humans; Polytetrafluoroethylene; Blood Vessel Prosthesis; Vascular Patency; Peripheral Arterial Disease; Heparin; Blood Vessel Prosthesis Implantation; Femoral Artery; Prosthesis Design; Aged; Limb Salvage; Male; Treatment Outcome; Anticoagulants; Female; Risk Factors; Time Factors; Coated Materials, Biocompatible; Middle Aged; Amputation, Surgical; Graft Occlusion, Vascular; Risk Assessment; Aged, 80 and over
PubMed: 38582218
DOI: 10.1016/j.avsg.2024.01.022 -
Annals of Vascular Surgery Aug 2024Endovascular deep vein arteriaization (DVA) is a novel technique aimed at salvaging peripheral arterial disease unamenable to conventional surgical intervention. This... (Review)
Review
BACKGROUND
Endovascular deep vein arteriaization (DVA) is a novel technique aimed at salvaging peripheral arterial disease unamenable to conventional surgical intervention. This study aims to review contemporary literature on the efficacy, safety, and durability of DVA on patients with no-option critical limb ischemia (NO-CLI).
METHODS
The study was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement, using predefined search terms of "percutaneous deep vein arterialization" or "percutaneous deep venous arterialization" in PubMed, Web of Sciences, OvidSP, and Embase. Only studies with 5 or more patients were included, and studies involving open or hybrid DVA were excluded. The primary outcomes included technical success and primary amputation rates. Secondary outcomes included rates of wound healing, complication, reintervention, and all-cause mortality.
RESULTS
Ten studies encompassing a total of 233 patients were included. Patients were primarily those deemed to have NO-CLI. The median follow-up period was 12 months (range 1-63 months). The technical success rate was 97% (95% confidence interval [CI] 96.2%-97.9%) and the major amputation rate was 21.8% (95% 21.1%-22.4%). The wound healing rate was 69.5% (95% CI 67.9-71.0%), complication rate was 13.8% (95% CI 11.7%-15.9%), reintervention rate was 37.4% (95% CI 34.9%-39.9%), and all-cause mortality rate was 15.7% (95% CI 14.1%-17.2%).
CONCLUSIONS
Our study showed that endovascular DVA is safe for patients with NO-CLI. Nonetheless, studies were small with follow-up period of less than 1 year. There is currently lack of level 1 evidence to recommend routine use in patients with NO-CLI.
Topics: Humans; Treatment Outcome; Amputation, Surgical; Limb Salvage; Risk Factors; Time Factors; Peripheral Arterial Disease; Endovascular Procedures; Aged; Female; Male; Veins; Middle Aged; Wound Healing; Critical Illness; Aged, 80 and over; Ischemia
PubMed: 38579910
DOI: 10.1016/j.avsg.2024.01.008 -
PloS One 2024Health state utility values (HSUV) for Type 2 diabetes mellitus (T2DM) complications are useful in economic evaluations to determine cost effectiveness of an...
INTRODUCTION
Health state utility values (HSUV) for Type 2 diabetes mellitus (T2DM) complications are useful in economic evaluations to determine cost effectiveness of an intervention. However, there is a lack of reference ranges for different severity and stages of individual complications. This study aimed to provide an overview of HSUV decrement ranges for common T2DM complications focusing on different severity and stages of complications.
METHOD
A systematic search was conducted in MEDLINE, SCOPUS, WEB OF SCIENCE. (Jan 2000 to April 2022). Included studies for HSUV estimates were from outpatient setting, regardless of treatment types, complication stages, regions and HRQoL instruments. Health Related Quality of Life (HRQoL) outcomes was to be presented as HSUV decrement values, adjusted according to social demographics and comorbidities. Adjusted HSUV decrements were extracted and compiled according to individual complications. After which, subsequently grouped into mild or severe category for comparison.
RESULTS
Searches identified 35 studies. The size of the study population ranged from 160 to 14,826. The HSUV decrement range was widest for cerebrovascular disease (stroke): -0.0060 to -0.0780 for mild stroke and -0.035 to -0.266 for severe stroke; retinopathy: mild (-0.005 to -0.0862), moderate (-0.0030 to -0.1845) and severe retinopathy (-0.023 to -0.2434); amputation: (-0.1050 to -0.2880). Different nature of complication severity defined in studies could be categorized into: those with acute nature, chronic with lasting effects, those with symptoms at early stage or those with repetitive frequency or episodes.
DISCUSSION
Overview of HSUV decrement ranges across different stages of each T2DM diabetes-related complications shows that chronic complications with lasting impact such as amputation, severe stroke with sequelae and severe retinopathy with blindness were generally associated with larger HSUV decrement range. Considerable heterogeneities exist across the studies. Promoting standardized complication definitions and identifying the most influential health state stages on HSUV decrements may assist researchers for future cost-effectiveness studies.
Topics: Humans; Diabetes Mellitus, Type 2; Quality of Life; Diabetes Complications; Stroke; Retinal Diseases
PubMed: 38574169
DOI: 10.1371/journal.pone.0297589 -
The Pan African Medical Journal 2024During the 1970s, scientists first used botulinum toxin to treat strabismus. While testing on monkeys, they noticed that the toxin could also reduce wrinkles in the... (Review)
Review
During the 1970s, scientists first used botulinum toxin to treat strabismus. While testing on monkeys, they noticed that the toxin could also reduce wrinkles in the glabella area. This led to its widespread use in both medical and cosmetic fields. The objective of the study was to evaluate the potential use of Botox in managing post-operative contracture after below-knee amputation. We conducted a systematic review In Pubmed, Cochrane Library, Embase, and Google Scholar using the MESH terms Botox, botulinum toxin, post-operative contracture, amputation, and below knee amputation. Our goal was to evaluate the potential use of Botox to manage post-operative contracture in patients who have undergone below-knee amputation. Our findings show evidence in the literature that Botox can effectively manage stump hyperhidrosis, phantom pain, and jumping stump, but no clinical trial has been found that discusses the use of Botox for post-operative contracture. Botox has been used in different ways to manage spasticity. Further studies and clinical trials are needed to support the use of Botox to manage this complication.
Topics: Humans; Botulinum Toxins, Type A; Amputation, Surgical; Contracture; Amputation Stumps; Muscle Spasticity; Joint Dislocations; Neuromuscular Agents
PubMed: 38558551
DOI: 10.11604/pamj.2024.47.26.42249