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BMC Musculoskeletal Disorders Jun 2024At present, the core decompression (CD) has become the main surgical procedure for the treatment of osteonecrosis of the femoral head (ONFH); however, the CD surgery... (Meta-Analysis)
Meta-Analysis Comparative Study
Comparison of clinical efficacy of robot-assisted and freehand core decompression in the treatment of osteonecrosis of the femoral head: a systematic review and meta-analysis.
OBJECTIVE
At present, the core decompression (CD) has become the main surgical procedure for the treatment of osteonecrosis of the femoral head (ONFH); however, the CD surgery requires high operator experience and repeated fluoroscopy increases the radiation damage to patients, and medical staff. This article compares the clinical efficacy of robot-assisted and freehand CD for ONFH by meta-analysis.
METHODS
Computer searches of PubMed, Web of Science, Embase, Cochrane Library, Chinese National Knowledge Infrastructure, China Science and Technology Journal Database, WanFang, and Chinese BioMedical Literature Database were conducted from the time of database inception to November 15, 2023. The literature on the clinical efficacy of robot-assisted and freehand CD in the treatment of ONFH was collected. Two researchers independently screened the literature according to the inclusion and exclusion criteria, extracted data, and strictly evaluated the quality of the included literature. Outcome measures encompassed operative duration, intraoperative blood loss volume, frequency of intraoperative fluoroscopies, visual analog scale (VAS) score, Harris hip score (HHS), complications, and radiographic progression. Data synthesis was carried out using Review Manager 5.4.1 software. The quality of evidence was evaluated according to Grades of Recommendation Assessment Development and Evaluation (GRADE) standards.
RESULTS
Seven retrospective cohort studies involving 355 patients were included in the study. The results of meta-analysis showed that in the robot-assisted group, the operative duration (MD = -17.60, 95% CI: -23.41 to -11.78, P < 0.001), intraoperative blood loss volume (MD = -19.98, 95% CI: -28.84 to -11.11, P < 0.001), frequency of intraoperative fluoroscopies (MD = -6.60, 95% CI: -9.01 to -4.20, P < 0.001), and ΔVAS score (MD = -0.45, 95% CI: -0.67 to -0.22, P < 0.001) were significantly better than those in the freehand group. The GRADE evidence evaluation showed ΔVAS score as low quality and other indicators as very low quality. There was no significant difference in the terms of ΔHHS (MD = 0.51, 95% CI: -1.34 to 2.35, P = 0.59), complications (RR = 0.30, 95% CI: 0.03 to 2.74, P = 0.29), and radiographic progression (RR = 0.50, 95% CI: 0.25 to 1.02, P = 0.06) between the two groups.
CONCLUSION
There is limited evidence showing the benefit of robot-assisted therapy for treatment of ONFH patients, and much of it is of low quality. Therefore, caution should be exercised in interpreting these results. It is recommended that more high-quality studies be conducted to validate these findings in future studies.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero/ #recordDetails, CRD42023420593.
Topics: Humans; Femur Head Necrosis; Decompression, Surgical; Treatment Outcome; Robotic Surgical Procedures; Operative Time
PubMed: 38890631
DOI: 10.1186/s12891-024-07592-x -
Global Spine Journal Jun 2024Systematic review and meta-analysis. (Review)
Review
Mechanical Vertebral Body Augmentation Versus Conventional Balloon Kyphoplasty for Osteoporotic Thoracolumbar Compression Fractures: A Systematic Review and Meta-Analysis of Outcomes.
STUDY DESIGN
Systematic review and meta-analysis.
OBJECTIVE
Surgical management of osteoporotic vertebral compression fractures (OVCFs) has traditionally consisted of vertebroplasty or kyphoplasty procedures. Mechanical percutaneous vertebral body augmentation (MPVA) systems have recently been introduced as alternatives to traditional methods. However, the effectiveness of MPVA systems vs conventional augmentation techniques for OVCFs remains unclear. This serves as the premise for this study.
METHODS
A systematic review and meta-analysis was conducted as per the guidelines. Studies of interest included randomized controlled trials (RCTs) which directly compared patient outcomes following kyphoplasty to patients treated with MPVA systems. Clinical and radiological findings were collated and compared for significance between cohorts.
RESULTS
6 RCTs were identified with 1024 patients total. The mean age of all patients was 73.5 years. 17% of the cohort were male, 83% were female. 515 patients underwent kyphoplasty and 509 underwent mechanical vertebral body augmentation using MPVA systems. MPVAs showed similar efficacy for restoration of vertebral body height ( = .18), total complications ( = .36), cement extravasation ( = .58) and device-related complications ( = .06). MPVAs also showed reduced rates of all new fractures (16.4% vs 22.2%; = .17) and adjacent fractures (14.7% vs 18.9%; = .23), with improved visual analogue scale (VAS) scores at 6-month ( = .13).
CONCLUSION
The results of this meta-analysis highlight no significant improvement in clinical or radiological outcomes for MPVA systems when compared to balloon kyphoplasty for vertebral body augmentation. Further research is needed to establish a true benefit over traditional operative methods.
PubMed: 38889443
DOI: 10.1177/21925682241261988 -
Clinical Cardiology Jun 2024Long-term follow-up results of various trials comparing Zotarolimus eluting stents (ZES) with Everolimus eluting stents (EES) have been published recently. Additionally,... (Comparative Study)
Comparative Study Meta-Analysis
Temporal Trends in the Outcomes of Percutaneous Coronary Intervention With Zotarolimus Eluting Stents Versus Everolimus Eluting Stents: A Meta-Analysis of Randomized Controlled Trials.
INTRODUCTION
Long-term follow-up results of various trials comparing Zotarolimus eluting stents (ZES) with Everolimus eluting stents (EES) have been published recently. Additionally, over the last decade, there have been new trials comparing the ZES with various commercially available EES. We aim to conduct an updated meta-analysis in light of new evidence from randomized controlled trials (RCTs) to provide comprehensive evidence regarding the temporal trends in the clinical outcomes.
METHODS
A comprehensive literature search was conducted across PubMed, Cochrane, and Embase. RCTs comparing ZES with EES for short (<2 years), intermediate (2-3 years), and long-term follow-ups (3-5 years) were included. Relative risk was used to pool the dichotomous outcomes using the random effects model employing the inverse variance method. All statistical analysis was conducted using Revman 5.4.
RESULTS
A total of 18 studies reporting data at different follow-ups for nine trials (n = 14319) were included. At short-term follow-up (<2 years), there were no significant differences between the two types of stents (all-cause death, cardiac death, Major adverse cardiovascular events (MACE), target vessel myocardial infarction, definite or probable stent thrombosis or safety outcomes (target vessel revascularization, target lesion revascularization, target vessel failure, target lesion failure). At intermediate follow-up (2-3 years), EES was superior to ZES for reducing target lesion revascularization (RR = 1.28, 95% CI = 1.05-1.58, p < 0.05). At long-term follow-up (3-5 years), there were no significant differences between the two groups for any of the pooled outcomes (p > 0.05).
CONCLUSION
ZES and EES have similar safety and efficacy at short, intermediate, and long-term follow-ups.
Topics: Humans; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Percutaneous Coronary Intervention; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Factors; Sirolimus; Time Factors; Treatment Outcome
PubMed: 38888152
DOI: 10.1002/clc.24306 -
American Journal of Translational... 2024Rehabilitation after total knee arthroplasty (TKA) has become an indispensable part of the treatment strategy for degenerative joint disease. Despite some current... (Review)
Review
BACKGROUND
Rehabilitation after total knee arthroplasty (TKA) has become an indispensable part of the treatment strategy for degenerative joint disease. Despite some current research demonstrating efficacy of transcutaneous electrical acupoint stimulation (TEAS) for post-TKA rehabilitation, the evidence is not conclusive.
OBJECTIVE
To systematically assess the evidence supporting TEAS for rehabilitation after TKA.
METHODS
A literature search of the PubMed, Embase, The Cochrane Library, Chinese National Knowledge Infrastructure, Chinese Biomedical Literature Database, Wanfang, and Chinese Scientific Journal Data databases for relevant studies published up to October 16, 2023, was performed. Main indicators included visual analog scale (VAS) and functional scores; secondary indicators included range of motion (ROM), interleukin-6 (IL-6) and C-reactive protein (CRP) levels, and analgesia-related adverse events. Risk of bias was evaluated using the Cochrane Tool, and meta-analysis was performed using Review Manager version 5.4.
RESULTS
Twenty RCTs with 1295 participants were included. TEAS improved several outcomes compared to control groups. The TEAS group had significantly greater pain reduction at postoperative 6 h, 12 h, 24 h, 48 h, 72 h, 7 days, and 14 days. Moreover, TEAS significantly improved the Hospital for Special Surgery Knee Score, Knee Society Score, and ROM. Patients who underwent TEAS exhibited a lower incidence of analgesia-related adverse events and lower IL-6 and CRP levels.
CONCLUSIONS
Available evidence indicates that the application of TEAS in patients undergoing TKA is related to postoperative pain alleviation, functional improvement, and fewer adverse events associated with analgesia.
PubMed: 38883347
DOI: 10.62347/VZLG2317 -
AJOG Global Reports May 2024As the second most common surgery performed on women in the United States, hysterectomy techniques are constantly examined for validity and superiority. The vaginal... (Review)
Review
OBJECTIVE
As the second most common surgery performed on women in the United States, hysterectomy techniques are constantly examined for validity and superiority. The vaginal natural orifice transluminal endoscopic surgery (vNOTES) has increased in popularity since the first vNOTES hysterectomy was performed in 2012. We sought out to evaluate the safety and effectiveness of hysterectomy by vNOTES compared to conventional vaginal hysterectomy for various benign indications.
DATA SOURCES
We searched Scopus, Medline, PubMed, ClinicalTrials.Gov, and the Cochrane Library. Our search included all studies from each respective database's inception until September 1, 2023.
STUDY ELIGIBILITY CRITERIA
We included eligible studies that compare vNOTES hysterectomy versus conventional vaginal hysterectomy for various benign indications, and included at least one of our preselected outcomes. The main outcomes were estimated blood loss (mL), operation time (min), length of hospital stay (d), Visual Analogue Scale pain score at Day 1, intraoperative complications, and postoperative complications.
STUDY APPRAISAL AND SYNTHESIS METHODS
We analyzed data of our continuous outcomes using RevMan 5.4.1. Continuous outcomes were analyzed using mean difference (MD) and 95% confidence intervals (CIs) under the inverse variance analysis method. We assessed the quality of the studies using the ROBINS-I assessment tool.
RESULTS
We found 4 eligible studies to include in our analysis. Surgeon declared estimated blood loss was found to be similar in both groups (MD=-44.70 [-99.97, 10.57]; =.11). Also, the total length of hospital stay (in days) was found to be comparable in both groups (MD=-0.16 [-1.62, 1.30]; =.83). We also found no other statistically significant difference between hysterectomy by vNOTES and vaginal hysterectomy in other studied outcomes, including the duration of the operation, the Visual Analogue Scale Pain score after 1 day, intraoperative complications, and postoperative complications.
CONCLUSION
vNOTES seems to be associated with a nonsignificant lower surgeon declared estimated blood loss. We found no other significant differences in hospital stay, intraoperative, or postoperative outcomes. Further studies may clarify if other differences in safety or efficacy exist.
PubMed: 38883323
DOI: 10.1016/j.xagr.2024.100355 -
Plastic and Reconstructive Surgery.... Jun 2024Raynaud disease of the hands is a complex disorder resulting in inappropriate constriction and/or insufficient dilation in microcirculation. There is an emerging role...
BACKGROUND
Raynaud disease of the hands is a complex disorder resulting in inappropriate constriction and/or insufficient dilation in microcirculation. There is an emerging role for botulinum toxin type A (BTX-A) in the treatment armamentarium for refractory Raynaud disease. The aim of this systematic review was to critically evaluate the management of primary and secondary Raynaud disease treated with BTX-A intervention.
METHODS
We performed a Preferred Reporting Items for Systematic Reviews and Meta-Analyses-compliant systematic review of clinical studies assessing treatment of primary or secondary Raynaud disease with BTX-A by searching Ovid MEDLINE and Embase databases from inception to first August 2023. The review protocol was prospectively registered on the PROSPERO database (CRD42022312253).
RESULTS
Our search strategy identified 288 research articles, of which 18 studies [four randomized controlled trials (RCTs), two non-RCTs, five case series, and seven retrospective cohort studies] were eligible for analysis. Meta-analysis demonstrated that the probability of pain visual analog scale score improvement with BTX-A intervention was 81.95% [95% confidence interval (74.12-87.81) = 0.19, heterogeneity = 26%] and probability of digital ulcer healing was 79.37% [95% confidence interval (62.45-89.9) = 0.02, heterogeneity = 56%].
CONCLUSIONS
Delivery of BTX-A to digital vessels in the hand may be an effective management strategy for primary and secondary Raynaud disease. A definitive, appropriately-powered RCT with objective functional and patient-reported outcome measures is required to accurately assess and quantify the efficacy of BTX-A in Raynaud disease of the hands.
PubMed: 38881966
DOI: 10.1097/GOX.0000000000005885 -
Osteoarthritis and Cartilage Jun 2024To assess whether patient reported outcome measures (PROMs) improve after autologous conditioned serum (ACS) administration in patients with osteoarthritis. (Review)
Review
OBJECTIVE
To assess whether patient reported outcome measures (PROMs) improve after autologous conditioned serum (ACS) administration in patients with osteoarthritis.
METHODS
Databases and clinical trial registers were searched to March 2024 for randomised controlled trial (RCTs) comparing ACS vs comparators/controls. Primary outcomes were pain, function and stiffness measured with Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and visual analogue scale (VAS). Secondary outcome was complications. Risk of bias (RoB) and certainty of evidence were assessed using RoB 2 and the Grades of Recommendation, Assessment, Development and Evaluation Working Group (GRADE) respectively. Meta-analysis was undertaken using RevMan v5.4. Results are presented as standardised mean differences (SMD) or mean differences (MD) with 95% confidence intervals (CI). Sensitivity analysis compared all comparators and saline control.
RESULTS
Five RCTs were identified (n = 741 participants); two (n = 529 participants) compared ACS against saline (placebo). Three studies were "some concern" and two studies "high risk" for bias. Analysis comparing ACS with all comparators significantly favoured ACS at 6 months for WOMAC: SMD -0.61 (95% CI -1.01 to -0.21; p = 0.003); and VAS: SMD -1.24 (95% CI -2.11 to -0.38; p = 0.005); with high heterogeneity. Comparing ACS with saline, there was no significant difference in WOMAC or VAS at 6 months: SMD -0.40 (95% CI -0.93 to 0.12; p = 0.13) and MD -9.87 (95% CI -27.73 to 7.98, p = 0.28). Complications were similar: ACS (24.8%) vs saline (24.4%), with serious complications rare.
CONCLUSION
There is currently insufficient data to support the use of ACS in osteoarthritis with conflicting results when compared to alternative therapies and saline control, with high heterogeneity. Before consideration as a potential treatment, a high-quality multicentre RCT is required to assess the efficacy of ACS.
PubMed: 38878817
DOI: 10.1016/j.joca.2024.06.004 -
Journal of Foot and Ankle Research Jun 2024The objective of this systematic review is to determine the benefits and harms of heel lifts to any comparator for lower limb musculoskeletal conditions. (Review)
Review
INTRODUCTION
The objective of this systematic review is to determine the benefits and harms of heel lifts to any comparator for lower limb musculoskeletal conditions.
METHODS
Ovid MEDLINE, Ovid AMED, Ovid EMCARE, CINAHL Plus and SPORTDiscus were searched from inception to the end of May 2024. Randomised, quasi-randomised or non-randomised trials comparing heel lifts to any other intervention or no-treatment were eligible for inclusion. Data was extracted for the outcomes of pain, disability/function, participation, participant rating of overall condition, quality of life, composite measures and adverse events. Two authors independently assessed risk of bias and certainty of evidence using the GRADE approach at the primary time point 12 weeks (or next closest).
RESULTS
Eight trials (n = 903), investigating mid-portion Achilles tendinopathy, calcaneal apophysitis and plantar heel pain were included. Heel lifts were compared to exercise, ultrasound, cryotherapy orthotics, stretching, footwear, activity modification, felt pads and analgesic medication. No outcome was at low risk of bias and few effects (2 out of 47) were clinically important. Low-certainty evidence (1 trial, n = 199) indicates improved pain relief (55.7 points [95% CI: 50.3-61.1], on a 100 mm visual analogue scale) with custom orthotics compared to heel lifts at 12 weeks for calcaneal apophysitis. Very low-certainty evidence (1 trial, n = 62) indicates improved pain and function with heel lifts over indomethacin (35.5 points [95% CI: 21.1-49.9], Foot Function Index) at 12 months for plantar heel pain.
CONCLUSIONS
Few trials have assessed the benefits and harms of heel lifts for lower limb musculoskeletal conditions. Only two outcomes out of 47 showed clinically meaningful between group differences. However, due to very low to low certainty evidence we are unable to be confident in the results and the true effect may be substantially different.
REGISTRATION
PROSPERO registration number CRD42022309644.
Topics: Humans; Heel; Treatment Outcome; Musculoskeletal Diseases; Male; Female; Lower Extremity; Randomized Controlled Trials as Topic; Pain Measurement; Tendinopathy; Adult
PubMed: 38878299
DOI: 10.1002/jfa2.12031 -
Metabolism Open Jun 2024Insulin icodec is a novel, long-acting, once-weekly basal insulin analog. Its comparative efficacy and safety with basal once-daily insulins in type 2 diabetes mellittus...
BACKGROUND
Insulin icodec is a novel, long-acting, once-weekly basal insulin analog. Its comparative efficacy and safety with basal once-daily insulins in type 2 diabetes mellittus is uncertain.
OBJECTIVE
Evaluate potential efficacy, benefits and risks associated with icodec compared to once-daily basal insulin analogs (degludec or glargine).
METHODS
We systematically searched PubMed, Cochrane, and Embase for randomized controlled trials (RCTs) published until June 2023 comparing icodec versus long-acting insulin analogs (degludec and glargine) in type 2 diabetes mellitus (T2DM) with at least 12 weeks of follow-up. Binary endpoints were assessed with risk ratios (RRs) and continuous endpoints were compared using mean differences (MDs), with 95% confidence intervals (CIs). The protocol was registered in PROSPERO (CRD42023452468).
RESULTS
A total of seven RCTs and 3286 patients with T2DM were included, of whom 1509 (60.6%) received icodec treatment. The follow-up period ranged from 16 to 78 weeks. Compared with once-daily basal insulin analogs, icodec led to a greater improvement in HbA1c (MD -0.15%; 95% CI -0.21, -0.10; p < 0.0001; I = 0%) and time in range (TIR) (MD 2.83%; 95%CI 0.94; 4.71; p = 0.003; I = 22%). Body weight was increased with icodec treatment (MD 0.78 Kg; 95%CI 0.42, 1.15; p < 0.01; I = 86%). There was also a higher rate of injection site reactions (RR 1.89; 95%CI 1.12, 3.18; p = 0.016; I = 0%) and nasopharyngitis (RR 1.94; 95%CI 1.11, 3.38; p = 0.020; I = 0%) in the icodec group, compared with once-daily regimens. There was no significant difference between groups in fasting plasma glucose.
CONCLUSIONS
In this meta-analysis of RCTs, insulin icodec led to better control of HbA1c and TIR as compared with once-daily insulin regimens, albeit with increased weight gain and a higher rate of injection site reaction in the Icodec group.
PubMed: 38867845
DOI: 10.1016/j.metop.2024.100285 -
Photodiagnosis and Photodynamic Therapy Jun 2024Diabetic foot ulcer (DFU) is a chronic and challenging condition, addressed through various treatments including photodynamic therapy (PDT) and standard of care (SOC),... (Review)
Review
BACKGROUND
Diabetic foot ulcer (DFU) is a chronic and challenging condition, addressed through various treatments including photodynamic therapy (PDT) and standard of care (SOC), yet lacking consensus on the optimal approach. This study presents a comprehensive meta-analysis of randomized controlled trials to evaluate the efficacy and safety of PDT versus SOC in managing DFU.
METHODS
An extensive literature search was conducted across PubMed, Embase, and the Cochrane Library databases to identify RCTs that compared the effectiveness of PDT with SOC in treating DFU. The primary metrics evaluated included changes in ulcer area, wound healing indices, and pain levels experienced by the patients.
RESULTS
This meta-analysis incorporated data from 6 RCTs, encompassing 458 patients with 467 DFUs. The analysis indicated that while PDT led to a faster reduction in ulcer size compared to SOC, the difference was not statistically significant [mean difference (MD): 2.73cm², 95 % Confidence Interval (CI) -2.98 to 8.44; p > 0.05]. However, a notable improvement was observed in the wound healing rate in the PDT group [MD: 29.26 %, 95 % CI 7.24 to 51.28; p = 0.01]. Based on the Visual Analog Scale (VAS), pain assessment revealed no significant difference between the two treatment groups [MD: 2.35, 95 % CI -2.36 to 7.06; p = 0.33].
CONCLUSION
The study suggests that PDT might offer an enhanced healing rate for DFUs compared to SOC alone, potentially leading to improved patient outcomes. Importantly, our findings highlight the superiority of photodynamic therapy in accelerating ulcer healing without an associated increase in complications.
PROSPERO
2023 CRD42023493930.
PubMed: 38866070
DOI: 10.1016/j.pdpdt.2024.104228