Aims

The aim of this study was to explore parents’ experience of their child’s recovery, and their thoughts about their decision to enrol their child in a randomized controlled trial (RCT) of surgery versus non-surgical casting for a displaced distal radius fracture.

Extracapsular Hip Fractures (EHF's) are a significant health burden on healthcare services. Optimal treatment is controversial with conflicting evidence being reported. Currently treatment is undertaken with Intramedullary Nail (IMN) or Dynamic Hip Screw (DHS) constructs with a recent increase in IMN use (1). This study aims to conduct a systematic review of Randomised Control Trials published between 2020 and 2023 with particular focus on patient demographics and holistic patient outcomes.

Using a unified search-protocol, RCT's published between 2020 and 2023 were collected from CENTRAL, PubMed, MEDLINE and EMBASE. Rayyan software screened duplicates. Using the CASP and Cochrane Risk of Bias Tool papers were critically examined twice, and Blood Loss, Infection and Mobility described the patient journey. Patient demographics were recorded and were contrasted with geographically diverse cohort studies to compare population differences. Parametric tests were used to determine significance levels between population demographics, namely Age and Sex.

Eleven papers were included, representing 908 patients (436 Male). The mean age for patients was 64.39. There was considerable risk of bias in 7/11 studies owing to the randomization process and the recording of data. Four Cohort studies were selected for comparison representing 14314 patients. Mean age was significantly different between Cohort Studies and RCT's (Independent T-Test, df 13, t=7.8, p = <0.001, mean difference = 19.251, 95% CI = 13.888, 24.613). This was also true for sex ratios included in the studies (df 13, t = -2.268, p = 0.024, Mean Difference = -0.4884, 95% CI = -0.9702, -0.0066).

To conclude, RCT's published in the post COVID-19 era are not representative of patient demographics. This has the potential to provide inaccurate information for implant selection. Additionally further research must be conducted in how to better improve RCT patient inclusion so as to be more representative of patients whilst balancing the risks of operations.

Aims

The aim of this study was to explore clinicians’ experience of a paediatric randomized controlled trial (RCT) comparing surgical reduction with non-surgical casting for displaced distal radius fractures.

Abstract

This systematic review and meta-analysis aimed to compare the outcome of operative and non-operative management in adults with distal radius fractures, with an additional elderly subgroup analysis. The main outcome was 12-month PRWE score. Secondary outcomes included DASH score, grip strength, complications and radiographic parameters.

Randomised controlled trials of patients aged ≥18yrs with a dorsally displaced distal radius fractures were included. Studies compared operative intervention with non-operative management. Operative management included open reduction and internal fixation, Kirschner-wiring or external fixation. Non-operative management was cast/splint immobilisation with/without closed reduction. Version 2 of the Cochrane risk-of-bias tool was used.

After screening 1258 studies, 16 trials with 1947 patients (mean age 66yrs, 76% female) were included in the meta-analysis. Eight studies reported PRWE score and there was no clinically significant difference at 12 weeks (MD 0.16, 95% confidence interval [CI] −0.75 to 1.07, p=0.73) or 12 months (mean difference [MD] 3.30, 95% CI −5.66 to −0.94, p=0.006). Four studies reported on scores in the elderly and there was no clinically significant difference at 12 weeks (MD 0.59, 95% CI −0.35 to 1.53, p=0.22) or 12 months (MD 2.60, 95% CI −5.51 to 0.30, p=0.08). There was a no clinically significant difference in DASH score at 12 weeks (MD 10.18, 95% CI −14.98 to −5.38, p<0.0001) or 12 months (MD 3.49, 95% CI −5.69 to −1.29, p=0.002). Two studies featured only elderly patients, with no clinically important difference at 12 weeks (MD 7.07, 95% CI −11.77 to −2.37, p=0.003) or 12 months (MD 3.32, 95% CI −7.03 to 0.38, p=0.08).

There was no clinically significant difference in patient-reported outcome according to PRWE or DASH at either timepoint in the adult group as a whole or in the elderly subgroup.

Patients undergoing total hip or knee arthroplasty (THA/TKA) are commonly associated with high pain scores and narcotic use. Duloxetine is effective in relieving chronic pain. The aim of this study was to evaluate the safety and efficacy of duloxetine for pain management following THA/TKA.

Five major databases (PubMed, Embase, Scopus, Cochrane, and Web of Science) were searched for randomised controlled trials (RCTs) that compared duloxetine to placebo in patients that underwent THA/TKA. The primary outcome was pain reduction with rest and movement at short-term and long-term time intervals. Secondary outcomes were the use of analgesics, length of stay, and safety profile. The risk of bias was assessed using the Cochrane tool. Data were pooled using RevMan 5.4. The results were reported as mean difference (MD) or standardised MD (SMD) and 95% confidence intervals (CI).

Eight RCTs with 767 patients were included. 50.2% (n=385/767) of patients received duloxetine. After one day, duloxetine was superior to the control regarding pain reduction with rest (SMD= −0.22 [−0.41, −0.03], p=0.02) after sensitivity analysis and pain reduction at movement (SMD= −0.39 [−0.55, −0.24], p<0.001). Similarly, after 12 weeks, duloxetine significantly reduced pain with rest (SMD= −0.3 [−0.52, −0.09], p=0.006) and pain with movement (SMD= −0.52 [−0.87, −0.17], p=0.003). In addition, after sensitivity analysis, duloxetine was associated with less analgesic use after one day (MD= −4.65 [−7.3, −2.01], p<0.001) and two days (MD= −5.65 [−10.62, −0.67], p=0.03). Patients who received duloxetine also required fewer analgesics after three days. However, there was no significant difference between the duloxetine and control groups in analgesic use after one week, length of stay, and adverse events.

Duloxetine was superior to the placebo regarding short-term and long-term pain reduction with rest and movement following THA/TKA. Duloxetine reduced postoperative analgesic use. There was no significant difference between duloxetine and placebo regarding adverse events and length of stay.

Our objective was to conduct a systematic review and meta-analysis, comparing differences in clinical outcomes between either autologous or synthetic bone grafts in the operative management of tibial plateau fractures: a traumatic pattern of injury, associated with poor long-term functional prognosis.

A structured search of MEDLINE, EMBASE, The Bone & Joint and CENTRAL databases from inception until 07/28/2021 was performed. Randomised, controlled, clinical trials that compared autologous and synthetic bone grafts in tibial plateau fractures were included. Preclinical studies, clinical studies in paediatric patients, pathological fractures, fracture non-union or chondral defects were excluded. Outcome data was assessed using the Risk of Bias 2 (ROB2) framework and synthesised in random-effect meta-analysis. Preferred Reported Items for Systematic Review and Meta-Analysis guidance was followed throughout.

Six comparable studies involving 352 patients were identified from 3,078 records. Following ROB2 assessment, five studies (337 patients) were eligible for meta-analysis. Within these studies, more complex tibia plateau fracture patterns (Schatzker IV-VI) were predominant. Primary outcomes showed non-significant reductions in articular depression at immediate postoperative (mean difference −0.45mm, p=0.25, 95% confidence interval (95%CI): −1.21-0.31mm, I²=0%) and long-term (>6 months, standard mean difference −0.56, p=0.09, 95%CI: −1.20-0.08, I²=73%) follow-up in synthetic bone grafts. Secondary outcomes included mechanical alignment, limb functionality, defect site pain, occurrence of surgical site infections, secondary surgery, perioperative blood loss, and duration of surgery. Blood loss was lower (90.08ml, p<0.001, 95%CI: 41.49-138.67ml, I²=0%) and surgery was shorter (16.17minutes, p=0.04, 95%CI: 0.39-31.94minutes, I²=63%) in synthetic treatment groups. All other secondary measures were statistically comparable.

Our findings supersede previous literature, demonstrating that synthetic bone grafts are non-inferior to autologous bone grafts, despite their perceived disadvantages (e.g. being biologically inert). In conclusion, surgeons should consider synthetic bone grafts when optimising peri-operative patient morbidity, particularly in complex tibial plateau fractures, where this work is most applicable.

Hip fractures are a major cause of morbidity and mortality, and malnutrition is a critical determinant of these outcomes. This systematic review and meta-analysis aims to determine whether oral nutritional supplementation (ONS) improves postoperative outcomes in older patients with hip fracture. An electronic systematic literature search was conducted in August 2022 using four databases. Randomized trials documenting ONS in older patients with hip fracture (aged 50+) were included. Two reviewers evaluated study eligibility, data extraction and assessed study quality.

There were 812 studies identified of which 18 studies involving 1,512 patients met the inclusion criteria. The overall meta-analysis demonstrates that ONS was associated with a significant risk reduction in infective complications (odds ratio (OR) 0.54, 95%CI 0.38, 0.76), pressure ulcers (OR 0.54, 95%CI 0.33, 0.88), total complications rate (OR 0.57, 95%CI 0.42, 0.79). Length of hospital stay (LOS) was also significantly reduced (weighted mean difference (WMD) −2.01, 95%CI −3.52, −0.5), particularly in the rehabilitation LOS (WMD −4.17, 95%CI −7.08, −1.26). There was a tendency towards lower risk in mortality (OR 0.93, 95%CI 0.62, 1.4) and readmission (OR 0.52, 95%CI 0.16, 1.73), though statistical significance was not achieved. The overall compliance to ONS ranged from 64.1% to 100%, but no factors influencing compliance were identified.

This systematic review was the first to quantitatively demonstrate that ONS reduces half the risk of infective complications, pressure ulcers, total complication rate and reduces LOS. ONS should be a regular and integrated part of medical practice, especially given that the compliance to ONS is acceptable.

In recent literature, the fragility index (FI) has been used to evaluate the robustness of statistically significant findings of dichotomous outcomes. This metric is defined as the minimum number of outcome events to flip study conclusions from significant to nonsignificant. Orthopaedics literature is frequently found to be fragile with a median FI of 2 in 150 RCTs across spine, hand, sports medicine, trauma and orthopaedic oncology studies. While many papers discuss limitations of FI, we aimed to further characterize it by introducing the Fragility Likelihood (FL), a new metric that allows us to consider the probability of the event to occur and to calculate the likelihood of this fragility to be reached.

We systematically reviewed all randomized controlled trials in the Journal of Bone and Joint Surgery (Am) over 10 years. The FL was calculated with the following formula: A x B x C x 100% (A= FI; B = probability of the event in the group with the smallest number of events; C= probability of the non-event in the group with the highest number of events). A smaller FL demonstrates more robust results and conversely, a larger FL illustrates a higher likelihood of fragility being reached and more fragile the findings.

The median FI for the statistically significant outcomes was 2 (Mean: 3.8; Range 0-23). The median FL for the statistically significant outcomes was 11% (Mean: 22%, Range: 2%-73%). This means that the probability of reaching non-significance is only 11% when considering the probability of the event to occur. When comparing studies with the same FI we found the FL to range from 3% to 43%. This illustrates the large differences in robustness between trials with equal FI when the likelihood of the event was taken into consideration.

As orthopaedic studies are frequently reported as fragile, we found that by calculating the FL, studies may be more robust than previously assumed based off FI alone. By using the FL in conjunction with FI and p-values will provide additional insight into the robustness of the reported outcomes. Our results indicate that by calculating the FL, study conclusions are stronger than what the FI alone predicts. Although conducting RCTs in surgery can be challenging, we must endeavor to critically evaluate our results so we can answer important orthopaedic questions with certainty.

Distal radius fractures (DRF) are common and the indication for surgical treatment remain controversial in patients higher than 60 years old. The purpose of the study was to review and analyze the current evidence-based literature.

We performed a systematic review and meta-analysis according to PRISMA guidelines in order to evaluate the efficacy of volar locking plating (VLP) and conservative treatment in DRF in patients over 60 years old. Electronic databases including MEDLINE, CENTRAL, Embase, Web of science and Clinical Trial.gov were searched from inception to October 2020 for randomized controlled trials. Relevant article reference lists were also passed over.

Two reviewers independently screened and extracted the data. Main outcomes included functional status: wrist range of motion, validated scores and grip strength. Secondary outcomes include post-operative complications and radiologic assessment.

From 3009 screened citations, 5 trials (539 patients) met the inclusion criteria. All trials of this random effect meta-analysis were at moderate risk of bias due to lack of blinding. Differences in the DASH score (MD −5,91; 95% CI, −8,83; −3,00), PRWE score (MD −9.07; 95% CI, −14.57, −3.57) and grip strength (MD 5,12; 95% CI, 0,59-9,65) were statistically significant and favored VLPs. No effect was observed in terms of range of motion. Adverse events are frequent in both treatment groups, reoperation rate is higher in the VLP group.

VLP may provide better functional outcomes in patients higher than 60 years old. More RCT are still needed to evaluate if the risks and complications of VLP outweigh the benefits.

Distal radius fractures (DRF) are common and the indication for surgical treatment remain controversial in patients higher than 60 years old. The purpose of the study was to review and analyze the current evidence-based literature.

We performed a systematic review and meta-analysis according to PRISMA guidelines in order to evaluate the efficacy of volar locking plating (VLP) and conservative treatment in DRF in patients over 60 years old. Electronic databases including MEDLINE, CENTRAL, Embase, Web of science and Clinical Trial.gov were searched from inception to October 2020 for randomized controlled trials. Relevant article reference lists were also passed over.

Two reviewers independently screened and extracted the data. Main outcomes included functional status: wrist range of motion, validated scores and grip strength. Secondary outcomes include post-operative complications and radiologic assessment.

From 3009 screened citations, 5 trials (539 patients) met the inclusion criteria. All trials of this random effect meta-analysis were at moderate risk of bias due to lack of blinding. Differences in the DASH score (MD −5,91; 95% CI, −8,83; −3,00), PRWE score (MD −9.07; 95% CI, −14.57, −3.57) and grip strength (MD 5,12; 95% CI, 0,59-9,65) were statistically significant and favored VLPs. No effect was observed in terms of range of motion. Adverse events are frequent in both treatment groups, reoperation rate is higher in the VLP group.

VLP may provide better functional outcomes in patients higher than 60 years old. More RCT are still needed to evaluate if the risks and complications of VLP outweigh the benefits.

To systematically review the literature regarding post-surgical treatment regimens on ankle fractures, specifically whether there is a benefit to early weightbearing or early mobilization (6 weeks form surgery).

The PubMed, MEDLINE and Embase databases were searched from inception to May 24, 2020. All randomized controlled trials that analyzed the effects of early weightbearing and mobilization following an ankle surgery were included. The primary outcome measure was the Olerud Molander Ankle Score (OMAS). Secondary outcomes included return to work (RTW) and complications. Logistic regression models with random intercepts were used to pool complication data by protocol clustered by study.

Twelve RCT's were included, with a total of 1177 patients (41.8 ± 8.4 years). In total, 413 patients underwent early weightbearing and early mobilization (35%), 338 patients underwent early weightbearing and delayed mobilization (29%), 287 patients underwent delayed weightbearing and early mobilization (24%), and 139 patients underwent delayed weightbearing and delayed mobilization (12%). In total, 81 patients had a complication (7%), including 53 wound complications (5%), 11 deep vein thromboses (1%), and 2 failures/nonunions (0%). Early ankle mobilization resulted in statistically significant increases in OMAS scores compared to delayed mobilization (3 studies [222 patients], 12.65; 95% CI, 7.07-18.22; P < 0.00001, I2 = 49%). No significant differences were found between early and delayed weightbearing at a minimum of one-year follow-up (3 studies [377 patients], 1.91; 95% CI, −0.73-4.55, P = 0.16, I2 = 0%). Patients treated with early weightbearing and early mobilization were at higher odds of facing any complication (OR 3.6, 95%CI 1.05-12.1, p=0.041) or wound complications (OR 4.9, 95%CI 1.3-18.8, p=0.022) compared to those with delayed weightbearing and delayed mobilization.

Early mobilization following surgical treatment for an ankle fracture resulted in improved ankle function scores compared to delayed mobilization regimens. There were no significant differences between early and delayed weightbearing with respect to patient reported outcomes. Patients who were treated with early mobilization and early weightbearing had an increased odds of postoperative complications.

Background

Advice and education are considered vital components of back pain care within national guidelines. However, a recent systematic review only found low grade evidence for a small average effect. They also reported wide heterogeneity in intervention design and delivery. This review aimed to understand why intervention design varied and what limited effectiveness by examining the underlying theoretical foundations of the studies from that review.

Worldwide, it is expected that 6.3 million patients will sustain a hip fracture in 2050. Hemiarthroplasty is commonly practiced for displaced femoral neck fractures. The choice between unipolar (UH) or bipolar (BH) hemiarthroplasty is still controversial. The objective of this study was to assess the effect on hip function of BH compared to UH for a displaced femoral neck fracture in elderly patients.

We conducted a systematic review and meta-analysis of randomized controlled trials comparing BH to UH. Data sources were Medline, Embase, Cochrane Library and Web of Science. All data was pooled in Review Manager (RevMan) version 5.3 software. Selection of the studies included, data abstraction, data synthesis, risk of biais and quality of evidence evaluation was done independently by two authors. Our primary outcome was postoperative hip function. Secondary outcomes were health-related quality of life (HRQoL), acetabular erosion and postoperative complications.

13 randomized controlled trials (n=2256) were eligible for the meta-analysis. There was no difference in hip function scores (standardized mean difference of 0.33 [−0.09–0.75, n=864, I²= 87%,]). Patients with bipolar heads had higher Health-Related Quality of Life scores than patients with unipolar heads (mean difference in EQ-5D scores of 0.12 [0.04–0.19, n=550, I²= 44%]). The use of BH decreased the incidence of acetabular erosion (relative risk of 0.37 [0.17–0.83, n=525, I²= 0%]). There was no relative risk difference for mortality, dislocation, revision and infection.

Due to the high heterogeneity between the studies included, it is still unclear whether patients undergoing BH have better hip function than patients undergoing UH. Although, health-related quality of life (HRQoL) may be improved. Future research could be conducted to determine whether a BH offers a better quality of life than UH to geriatric patients undergoing surgery. More precise assessment scores could be developed to better evaluate postoperative outcomes.

The aim was to analyze the efficacy of zoledronic acid (ZA) versus denosumab in the prevention of pathological fractures in patients with bone metastases from advanced cancers by evaluating all available randomized controlled trials (RCTs) on this subject.

A systematic search of electronic databases (PubMed and MEDLINE) was performed to identify all published RCTs comparing zoledronic acid with denosumab in prevention of pathological fractures in bone metastases. Risk of bias of the studies was assessed. The primary outcomes evaluated were pathological fractures.

Four RCTs (7320 patients) were included. Denosumab was superior to ZA in reducing the likelihood of pathological fractures, when all tumour types were combined (OR 0.86, 95% CI [0.74, 0.99], p = 0.04). Denosumab was not significantly favoured over ZA in endodermal origin (breast and prostate) (OR 0.85, 95% CI [0.68, 1.05], p = 0.13) and mesodermal origin tumours (solid tumours and MM) (OR 0.87, 95% CI [0.71, 1.06], p = 0.16).

Denosumab significantly reduces the likelihood of pathological fractures in comparison to ZA in patients with bone metastases. When pathological fractures were grouped by tumour origin (endodermal or mesodermal), there was no significant difference between denosumab and ZA. Further long-term studies are needed to confirm the effectiveness of these treatment regimens.

Aims

Pin-site infection remains a significant problem for patients treated by external fixation. A randomized trial was undertaken to compare the weekly use of alcoholic chlorhexidine (CHX) for pin-site care with an emollient skin preparation in patients with a tibial fracture treated with a circular frame.

Aims

Modern total knee arthroplasty (TKA) prostheses are designed to restore near normal kinematics including high flexion. Kneeling is a high flexion, kinematically demanding activity after TKA. The debate about design choice has not yet been informed by six-degrees-of-freedom in vivo kinematics. This prospective randomized clinical trial compared kneeling kinematics in three TKA designs.

The aim was to analyze whether non-steroidal anti-inflammatory drugs (NSAIDs) have an adverse effect on bone healing by evaluating all available human randomized controlled trials (RCTs) on this subject.

A systematic search of electronic databases (PubMed, MEDLINE, and Cross-References) was performed to identify RCTs comparing the occurrence of nonunion in patients who received NSAIDs to the control group. Risk of bias of the studies was assessed. Nonunion was the main outcome evaluated, however, regression analysis was used to estimate the relative risk comparing duration and type of NSAIDs.

Six RCTs (609 patients) were included. The risk of nonunion was higher in the patients given NSAIDs after the fracture (P-value= 0.0009, relative risk [RR] = 2.9, 95% confidence interval [CI] = 1.6 to 6.3). However, once the studies have been categorized to the duration of NSAIDs, those who received short period of NSAIDs (4 weeks) (P-value = 0.0002, RR = 4.1, CI = 2.1 to 8). Also, indomethacin agent has associated with high nonunion (P-value = 0.0001, RR = 3.9, CI = 2.3 to 13.9) compared to other NSAIDs which did not show a nonunion risk (P-value = 0.24, RR = 2.3, CI = 0.6 to 8.9).

Using NSAIDs for long period (> 4 weeks) after fracture is significantly associated with nonunion especially with indomethacin agent. However, short period of NSAIDs (< 2 weeks) did not show the adverse effects of nonunion. Overall, further studies are required to support our conclusion.

Aims

Describe a statistical and economic analysis plan for the Distal Radius Acute Fracture Fixation Trial 2 (DRAFFT2) randomized controlled trial.

Background

Complex interventions, such as exercise for LBP, often have many treatment targets. Matching a primary outcome to the target(s) of exercise interventions may provide greater standardized mean differences (SMDs) than using an unmatched primary outcome. We aimed to explore whether the conclusions of exercise trials for LBP might differ with i) improved matching of outcomes to treatment targets and ii) the use of composite outcome measures.