Is wound drainage necessary in hip arthroplasty? A meta-analysis of randomized controlled trials

Purpose

The use of closed suction drainage systems for hip arthroplasty (HA) is a common practice. However, the effectiveness and safety are still questionable. Thus, the aim of this meta-analysis was to review the advantages and adverse effects of closed suction drainage systems in hip arthroplasty.

Methods

All randomized or quasi-randomized trials comparing the use of closed suction drainage systems with no drainage systems for hip arthroplasty were searched in PubMed, Medicine, EMBASE and other internet databases. We assessed the methodological quality of the studies and abstracted the relevant data independently.

Results

Sixteen studies involving 1,663 participants with surgical wounds comparing HA with and without the use of drainage were included in our analysis. Our results demonstrated blood transfusion was required more frequently the same as the persistent discharge in those who received drains. No significant differences in the incidence of wound hematoma, dehiscence or deep vein thrombosis were found between those allocated to drains and the non-drained wounds. Wound infection and the range of movement of the joint after surgery were similar between the two groups.

Conclusions

Based on the current evidence, there is insufficient evidence to support the routine use of closed suction drainage in hip arthroplasty. At the same time, our meta-analysis study suggested that using of closed suction drainage in HA increased requirement for postoperative blood transfusion. However, there is a moderate possibility of selection bias and publication bias in this review. Because of the limited number of studies which may weaken the strength of the evidence of our results, more samples, high-quality randomized trials are needed to increase the reliability of evidences.

Level of evidence

II.     

Do hip protectors decrease the risk of hip fracture in institutional and community-dwelling elderly? A systematic review and meta-analysis of randomized controlled trials

Hip fractures are an important cause of morbidity and mortality in the elderly. Hip protectors are padded undergarments designed to decrease the impact of a fall on the hip. We systematically reviewed randomized controlled trials of hip protectors to determine if they reduce hip fractures in the elderly. Analyses were pooled according to participant residence—community or institutional (the latter, included nursing homes, residential group homes or seniors hostels). We included individually randomized and statistically adjusted cluster randomized trials. Seven trials of 12- to 28-month duration were included. The Safehip brand of hip protector was used in most studies. Compliance rates in the treatment groups varied from 31 to 68%. In four trials including a total of 5,696 community-dwelling seniors, the hip fracture rates in control groups ranged from 1.1 to 7.4%, and the pooled risk difference with hip protector allocation was 0% [95% confidence intervals (CI), –1%, +1%), with a relative risk of 1.07 (0.81, 1.42). In three trials including 1,188 institutionalized elderly participants, hip fracture rates in the control groups varied from 8 to 19.4%, and the pooled risk difference for sustaining one or more hip fractures with hip protector allocation was –3.7% (95% CI, –7.4%, 0.1%), with a relative risk of 0.56 (0.31, 1.01) (with statistically significant heterogeneity of treatment effect). In a post-hoc subgroup analysis of two trials comprised of exclusively nursing home residents, the risk difference with hip protector allocation was –4.4% (–8.09, –0.76) with a relative risk of 0.50 (0.28, 0.91) ( n =1,014). Thus, there is little evidence to support the use of hip protectors outside the nursing home setting. The potential benefit of hip protectors in reducing hip fractures in nursing home residents requires further confirmation.     

Do we really need tranexamic acid in total hip arthroplasty? A meta-analysis of nineteen randomized controlled trials

Background

Studies have shown that tranexamic acid reduces blood loss and transfusion need in patients undergoing total hip arthroplasty. However, no to date, no study has been large enough to determine definitively whether the drug is safe and effective. We examined whether intravenous tranexamic acid, when compared with placebo, was safe and effective in total hip arthroplasty.

Methods

The literature search was conducted using the PubMed, Cochrane Library, MEDLINE, EMBASE, and China National Knowledge Infrastructure (CNKI) databases. Data were evaluated using the generic evaluation tool designed by the Cochrane Bone, Joint and Muscle Trauma Group. Ultimately, 19 randomized controlled trials involving 1,030 patients were included.

Results

The use of tranexamic acid significantly reduced total blood loss by a mean of 305.27 mL [95 % confidence interval (CI) ?397.66 to ?212.89, p < 0.001], intraoperative blood loss by a mean of 86.33 mL(95 % CI ?152.29 to ?20.37, p = 0.01), postoperative blood loss by a mean of 176.79 mL (95 % CI ?236.78 to ?116.39, p < 0.001), and “hidden” blood loss by a mean of 152.70 mL (95 % CI ?187.98 to ?117.42, p < 0.001), resulting in a meaningful reduction in the proportion of patients requiring blood transfusion (odds ratio 0.28, 95 % CI 0.19 to 0.42, p < 0.001). There was no significant difference in occurrence of deep vein thrombosis, pulmonary embolism, or other complications among the study groups, or cost or hospitalization duration.

Conclusions

The data from this meta-analysis indicate that intravenous tranexamic acid may reduce blood loss and transfusion need in patients undergoing total hip arthroplasty without increasing the risk of complications. However, high-quality randomized controlled trials are required to validate the results.     

Does vehicle-based delivery of mesenchymal stromal cells give superior results in knee osteoarthritis? Meta-analysis of randomized controlled trials

Study designMeta-analysis.ObjectivesWe aim to analyze and compare the efficacy and safety of vehicle-based delivery of Mesenchymal Stromal Cells (MSCs) in the management of osteoarthritis of the knee from Randomized Controlled Trials (RCTs) available in the literature.Materials and methodsWe conducted independent and duplicate electronic database searches including PubMed, Embase, Web of Science, and Cochrane Library till August 2021 for RCTs analyzing the efficacy and safety of vehicle-based delivery of MSCs in the management of knee osteoarthritis. Visual Analog Score (VAS) for Pain, Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score, and adverse events were the outcomes analyzed. Analysis was performed in R-platform using OpenMeta [Analyst] software.Results21 studies involving 936 patients were included for analysis. None of the studies made a direct comparison of the direct and vehicle-based delivery of MSCs, hence we pooled the results of all the included studies of both groups and made a comparative analysis of their outcomes. Although at 6 months, both direct and vehicle-based delivery of MSCs showed significantly better VAS improvement (p = 0.002, p = 0.010), it was not consistent at 1 year for the vehicle delivery (p = 0.973). During 6 months and 12 months, direct delivery of MSCs (p < 0.001, p < 0.001) outperformed vehicle delivery (p = 0.969, p = 0.922) compared to their control based on WOMAC scores respectively. Both direct (p = 0.713) and vehicle-based delivery (p = 0.123) of MSCs did not produce significant adverse events compared to their controls.ConclusionOur analysis of literature showed that current clinically employed methods of vehicle-based delivery of MSCs such as platelet-rich plasma, hyaluronic acid did not demonstrate superior results compared to direct delivery, concerning the efficacy of treatment measured by improvement in pain, functional outcomes, and safety. Hence, we urge future clinical trials to be conducted to validate the effectiveness of advanced delivery vehicles such as composite bioscaffolds to establish their practical utility in cartilage regeneration with respect to its encouraging in-vitro evidence.     

Does additional surgical training increase participation in randomized controlled trials?

BACKGROUND: The prospective randomized controlled trial (PRCT) is agreeably the gold standard in reporting data on patient management. This study evaluates the impact of specialty training on the leadership, development, and enrollment in PRCT. METHODS: Questionnaires were sent to surgical oncology as well as general surgery graduates from 1985 to 1999. RESULTS: A total of 67% (201 of 300) of the surgeons responded, with one half of the respondents completing a surgical oncology (SO) fellowship (50%, 100 of 201), 33% (66 of 201) another type of fellowship (OF), and 17% (35 of 201) general surgery (GS) training alone. The utilization of PRCT in the decision making of their clinical practice was reported by a majority of SO graduates (99%) as well as GS graduates (88%) with a smaller number (77%) of OF trained surgeons. The opinions on PRCT were evenly distributed with breast disease, colorectal cancer, and melanoma having the greatest impact on surgeons practicing in these fields. A greater percentage of SO (89%) reported participation in a PRCT than did the GS (42%) or OF (54%). The most frequent reason for the lack of participation in a PRCT by both GS and OF trained graduates was absence of active recruitment (80%) to participate with the second most common being no time available (18%). CONCLUSIONS: PRCT are utilized and continue to change surgeons' decision making for a majority of the surgeons surveyed. There are certain disease sites for which PRCT have failed to influence practice decisions. Unfortunately, few surgeons take a leadership role in PRCT. Emphasizing the existence of PRCT at both meetings, and in journals, with a more aggressive recruitment of participating surgeons with minimal time commitment, should enhance the patients included in prospective randomized controlled trials.     

Is tranexamic acid effective and safe in spinal surgery? A meta-analysis of randomized controlled trials

Purpose

The present meta-analysis aimed at assessing the effectiveness and safety of tranexamic acid (TXA) in reducing blood loss and transfusion in spinal surgery.

Methods

Systematic searches of all studies published through March 2012 were identified from PubMed, EMBase, Cochrane library, Science Direct, and other databases. Only randomized controlled trials (RCTs) were included in the present study. Two independent reviewers searched and assessed the literature. Mean difference (MD) of blood loss and blood transfusions, risk ratios (RR) of transfusion rate and of deep vein thrombosis rate in the TXA-treated group versus placebo group were pooled throughout the study. The meta-analysis was conducted by RevMan 5.1 software.

Results

Six placebo-controlled RCTs encompassing 411 patients met the inclusion criteria for our meta-analysis. The use of TXA significantly reduced both total blood loss [MD = −285.35, 95 % CI (−507.03 to −63.67), P = 0.01] as well as the number of patients requiring blood transfusion [RR = 0.71, 95 % CI (0.54–0.92), P = 0.01]. None of the patients in the treatment group had deep-vein thrombosis (DVT) or pulmonary embolism.

Conclusions

Intravenous use of TXA for patients undergoing spinal surgery is effective and safe. It reduces total blood loss and the need for blood transfusion, particularly in the using of high dosage of TXA (≥15 mg/kg), yet does not increase the risk of postoperative DVT. Due to the limitation of the quality of the evidence currently available, high-quality RCTs are required.     

What is the clinically significant ideal mesenchymal stromal cell count in the management of osteoarthritis of the knee? – Meta-analysis of randomized controlled trials

Study designMeta-analysis.ObjectivesWe aim to identify the clinically significant ideal Mesenchymal Stem Cell (MSC) count in the management of osteoarthritis of knee from Randomized Controlled Trials (RCTs) available in the literature.Materials and methodsWe conducted independent and duplicate electronic database searches including PubMed, Embase, Web of Science, and Cochrane Library till August 2021 for RCTs conducted in the management of knee osteoarthritis using MSC therapy specifying the quantity of MSCs delivered. We categorized the studies based on the MSC count utilized in them into four groups namely <1 × 10⁷ MSCs (Group I), 1-5x10⁷ MSCs (Group II), 5-10 × 10⁷ MSCs (Group III), and >10 × 10⁷ MSCs (Group IV). Visual Analog Score (VAS) for Pain, Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), Lysholm score, Knee Osteoarthritis Outcome Score (KOOS), and adverse events were the outcomes analyzed. Analysis was performed in R-platform using OpenMeta [Analyst] software.Results14 studies involving 564 patients were included for analysis. We noted incremental decrease in the VAS with increasing dosage of MSCs at 12 months [Group I,WMD = 2.641(p = 0.854); Group II, WMD = −4.853(p = 0.379); Group III, WMD = −12.154 (p = 0.316); Group IV, WMD = −15.935(p = 0.116)], and 24 months [Group I,WMD = −6(p = 0.001); Group II, WMD = −15(p = 0.001); Group IV, WMD = −20(p = 0.001)]. We also noted incremental improvement in the WOMAC, KOOS with increasing dosage of MSCs at 12 months [Group I, WMD = 7(p = 0.001); Group II, WMD = 28(p = 0.001); Group IV, WMD = 30(p = 0.001)] and [Group II, WMD = −2.562(p = 0.676); Group III, WMD = 7.670(p = 0.099); Group IV, WMD = 13.475(p = 0.261)] respectively. However, we noted significant reduction in the Lysholm score in Group IV, compared to the others at 12 months (WMD = −12.5, 95%CI[-25.883,0.883]) and 24 months (WMD = −6.6, 95%CI[-23.596,10.396]). We did not find any significant increase in the adverse events with incremental dosage of MSCs in any of the groups compared.ConclusionCompared to the four dosage groups of MSCs analyzed, Group III showed consistent significant improvement in pain and functional outcomes analyzed compared to the other groups. Hence, we recommend a cell volume of 5-10 × 10⁷ cells to be delivered to the target site to obtain superior benefits out of the procedure. However, we urge future trials of sufficient quality to validate our findings to arrive at a consensus on the ideal count of MSCs to be delivered in the cellular therapy for knee osteoarthritis.     

Is gabapentin effective and safe in open hysterectomy? A PRISMA compliant meta-analysis of randomized controlled trials

BackgroundPain management after open hysterectomy has been investigated for years. Owing to the effect of significant analgesic, gabapentin was often administrated for pre-emptive analgesia. However, the relationship between gabapentin and postoperative pain after open hysterectomy is still controversial. This meta-analysis was applied to assess the efficacy of pre-emptive use of gabapentin in open hysterectomy.MethodsThis meta-analysis of randomized controlled trials (RCTs) was performed to compare the use of gabapentin with placebo in open hysterectomy regarding (1) the mean difference (MD) of postoperative opioid requirements; (2) the changes of visual analogue scale (VAS) scores in two groups; and (3) incidence rate of adverse effects. Systematic searches of all related literatures was conducted using the following databases: MEDLINE, EMBASE, ClinicalTrials.gov and Web of Science. Only randomized controlled trials (RCTs) for open hysterectomy were included. The MD of postoperative opioid requirements and VAS scores, relative risk (RR) of incidence rate of adverse effects in the gabapentin group versus placebo group were extracted throughout the study.ResultsFourteen trials were included in this meta-analysis. The total opioid consumption at 24 h was a less in gabapentin group. (MD = − 11.61, 95% CI: − 16.71 to − 6.51, P = 0.00) The visual analogue scale (VAS) score at 4, 12 and 24 h were less in the gabapentin group. (MD = − 16.83, 95% CI: − 22.88 to − 10.77, P = 0.00), (MD = − 17.45, 95% CI: − 21.83 to − 13.08, P = 0.00), (MD = − 9.83, 95% CI: − 13.31 to − 6.35, P = 0.00) The incidence rate of vomiting and nausea were significantly less in gabapentin groups. (RR 0.13, 95% CI 0.45 to 0.73, P = 0.00), (RR 0.67, 95% CI 0.49 to 0.93, P = 0.02). Compared with placebo, gabapentin achieved higher patient satisfaction. (MD = 20.43, 95% CI: 12.42 to 28.44, P < 0.00).ConclusionThis meta-analysis suggested that the employment of gabapentin was efficacious in reduction of postoperative opioid consumption, VAS score and some side effects after open hysterectomy.     

Does alkalinised urine reduce the rate of encrustation in patients with ureteric stents? A randomised controlled study

International Urology and Nephrology - Stent encrustation is not uncommonly encountered with a high number of ureteric stents. The exact pathophysiology is not well understood. Therefore, we...     

Do the Y-set and double-bag systems reduce the incidence of CAPD peritonitis? A systematic review of randomized controlled trials.

BACKGROUND: Peritonitis is the most frequent serious complication of continuous ambulatory peritoneal dialysis (CAPD). It has a major influence on the number of patients switching from CAPD to haemodialysis and has probably restricted the wider acceptance and uptake of CAPD as an alternative mode of dialysis. This systematic review sought to determine if modifications of the transfer set (Y-set or double-bag systems) used in CAPD exchanges are associated with a reduction in peritonitis and an improvement in other relevant outcomes. METHODS: Based on a comprehensive search strategy, we undertook a systematic review of randomized or quasi-randomized controlled trials comparing double-bag and/or Y-set CAPD exchange systems with standard systems, or comparing double-bag with Y-set systems, in patients with end-stage renal disease (ESRD) treated with CAPD. Only published data were used. Data were abstracted by a single investigator onto a standard form and subsequently entered into Review Manager 4.0.4. Its statistical package, Metaview 3.1, calculated an odds ratio (OR) for dichotomous data and a (weighted) mean difference for continuous data with 95% confidence intervals. RESULTS: Twelve eligible trials with a total of 991 randomized patients were identified. In trials comparing either the Y-set or double-bag systems with the standard systems, significantly fewer patients (133/363 vs 158/263; OR 0.33, 95% CI 0.24-0.46) experienced peritonitis and the number of patient-months on CAPD per episode of peritonitis was consistently greater. When the double-bag systems were compared with the Y-set systems significantly fewer patients experienced peritonitis (44/154 vs 66/138; OR 0.44, 95% CI 0.27-0.71) and the number of patient-months on CAPD per episode of peritonitis was also greater. CONCLUSIONS: Double-bag systems should be the preferred exchange systems in CAPD.     

Does precut technique improve selective bile duct cannulation or increase post-ERCP pancreatitis rate? A meta-analysis of randomized controlled trials

Background  

There is no clear answer regarding use of precut technique versus conventional method in achieving successful biliary cannulation.     

Does unilateral total hip arthroplasty improve pain and function in the non-operative hip joint?

European Journal of Orthopaedic Surgery & Traumatology - Some reports suggested that the status of the opposite-side hip affects clinical outcomes of unilateral total hip arthroplasty (THA) for...     

What is the evidence for viscosupplementation in the treatment of patients with hip osteoarthritis? Systematic review of the literature

Introduction

Osteoarthritis (OA) is a disease of the synovial joints and is the most common cause of chronic pain in the elderly. One of the treatment modalities for OA of the hip is viscosupplementation (VS). Today there are several different formulations of viscosupplements produced by different manufactures of different molecular weights. The objective of this review is to asses the efficacy of VS treatment of hip OA osteoarthritis in the current literature.

Material and methods

The following databases were searched: Medline (period 1966 to November 2006), Cochrane Database of Systematic Reviews (1988 to November 2006), Cochrane Clinical Trial Register (1988 to November 2006), Database of Abstracts on Reviews and Effectiveness, Current Controlled Trials, National Research Register and Embase (January 1988 to November 2006). The search terms [osteoarthritis, hip (joint), viscosupplementation, hyaluronic acid, hyaluronan, sodium hyaluronate and trade names] were applied to identify all studies relating to the use of VS therapy for OA of the hip joint.

Results

Sixteen articles concerning the efficacy of a total of 509 patients undergoing VS treatment for hip OA were included. Twelve European studies, three Turkish studies and one American study with Levels of Evidence ranging from I to IV evaluated the following products: Hylan G-F 20, Hyalgan^®, Ostenil^®, Durolane^®, Fermatron^® and Orthovisc^®. Heterogeneity of included studies did not allow pooled analysis of data.

Discussion

Despite the relatively low Level of Evidence of the included studies, VS performed under fluoroscopic or ultrasound guidance seems an effective treatment and may be an alternative treatment of hip OA. Intra-articular injection of (derivatives of) HA into the hip joint appears to be safe and well tolerated. However, VS cannot be recommended as standard therapy in hip OA for wider populations, and therefore the indications remain a highly individualised matter.

     

Does a lidocaine patch reduce the pain at venous cannulation in adults?

In this study we evaluated whether a lidocaine patch reduces the pain relating to a venous cannulation in adults. The patch is consisted of the base containing 50% lidocaine on a thin polyester membrane. Its surface area is 15 cm2. Twenty-six adult patients scheduled for elective surgery (11 males and 15 females) were randomly divided into two groups according to application periods: Group A for 15 min and Group B for 30 min. Either the dorsal part of the hand or the radial side of the wrist was chosen and covered with the patch. Pain assessment was made by patients using a 0-100 point visual analog scale (VAS). In 7 patients of Group A, plasma lidocaine levels were measured 15 min after application by homogeneous enzyme immunoassay. The levels were further measured 30 and 60 min after application in 3 of those patients. The mean VAS score was 28.4 +/- 13.1 (mean +/- SD) for Group A and 51.8 +/- 15.9 for Group B, and the difference was statistically significant (P < 0.05). Plasma lidocaine levels were always below 0.2 microg.ml(-1). The results indicate that the skin was partially anesthetized by the lidocaine patch. A lidocaine patch may be useful and safely applicable for venous cannulation in adult patients.