Total knees today are performed with the use of standard trials that the surgeon utilises to define appropriate implant rotation, range of motion, and soft tissue balance. This “feel” based approach is very subjective, and lacks a quantifiable approach to interpret our intra-operative knee assessment. Sensor-based trials are embedded into the specific knee designed tibial trial, and wirelessly displays data related to the implant's position and ligament tension. The surgeon can now identify malrotation, soft tissue imbalance, and instability through a full ROM. The surgeon can see dynamic responses to ligament releases, alignment changes, and implant adjustments. As Insall taught us; a TKR is a soft tissue procedure, and a “balanced” knee will demonstrate improved outcomes and greater patient satisfaction. Smart
Persistent post-surgical pain affects 10%-80% of individuals after common operations, and is more common among patients with psychological factors such as depression, anxiety, or catastrophising. We conducted a systematic review and meta-analysis of randomised, controlled trials to evaluate the efficacy of perioperative psychotherapy for persistent postsurgical pain and physical impairment. We searched Medline, PsycINFO, CINAHL, and the Cochrane Central Registry of Controlled
A commonly misunderstood principle in medical literature is statistical significance. Often, statistically non-significant or negative results are thought to be evidence for equivalence; mistakenly validating treatment modalities and putting patients at risk. This study examines the prevalence of misinterpretation of negative results of superiority trials in orthopaedic literature and outlines the need for a non-inferiority or equivalence research design. Four orthopaedic journals – Journal of Paediatric Orthopaedics A, Journal of Bone and Joint Surgery American Volume, Journal of Arthroplasty and Journal of Shoulder and Elbow Surgery – were hand searched to identify all randomised control trials (RCTs) published within the time periods 2002–2003, 2007–2008 and 2012–2013. The identified RCTs were read and classified by study methodology, results obtained, and interpretation of results. A total of 237 RCTs were identified. When analysing the primary outcomes, 117 (49.4%) studies yielded negative results and 120 (50.8%) yielded positive results. Out of the 237 articles, 231 (97.5%) used superiority methodology and 6 (2.5%) used non-inferiority or equivalence methodology. Of the 231 studies that used superiority methodology, 115 (49.8%) obtained negative results; and 45 (39.1%) of those misinterpreted the negative results for equivalence. While no statistical differences were seen, there was an upward trend in utilising non-inferiority and equivalence methodologies over time. Given the frequency of misinterpreted negative results, there is an evident need for a more appropriate research methodology that shows equivalence of treatment methods. A non-inferiority or equivalence study design can address orthopaedic clinical dilemmas more suitably when trying to show one treatment is no worse or is equal to another treatment. Regarding orthopaedic treatment modalities as equivalent when studies show negative statistical results can be detrimental to patients and their clinical outcomes. A non-inferiority methodology can be used to accurately depict no difference between treatment methods rather than attempting to show one treatment method as superior.
Many orthopaedic procedures require implants to be trialled before definitive implantation. Where this is required, the trials are provided in a set with the instrumentation. The most common scenario this is seen in during elective joint replacements. In Scotland (2007) the Scottish Executive (. http://www.sehd.scot.nhs.uk/cmo/CMO(2006)13.pdf. ) recommended and implemented individually packed orthopaedic implants for all orthopaedic sets. The premise for this was to reduce the risk of CJD contamination and fatigue of implants due to constant reprocessing from corrosion. During many trauma procedures determining the correct length of plate or size of implant can be challenging.
Backgroud:. Periarticular multimodal drug injection (PMDI) during total knee arthroplasty (TKA) has been reported with promising effects, but some results still remain controversial. Therefore, we conducted a systematic review and meta-analysis based on randomized controlled trials (RCTs) to evaluate the efficiency and safety of PMDI technique in TKA. Methods:. We systematically conducted an electronic search in the databases of PubMed, Embase, Cochrane Central Register of Controlled
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.
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.
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.
Although non-unions being one of the most common complication after long-bone fracture fixation, the definition of this entity remains controversial and varies widely among authors. A clear definition is crucial, not only for the evaluation of published research data but also for the establishment of uniform treatment concepts. The aim of this systematic review was to identify the definitions and different criteria used in the scientific literature to describe non-unions after long bone fractures. A comprehensive literature search was performed in PubMed, Cochrane Library, Web of Science, and Embase. according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Prospective therapeutic and diagnostic clinical studies in which adult long-bone fracture non-unions were investigated as main subject were included in this analysis.Aim
Method
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.
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.
Fifteen-year survivorships studies demonstrate that total knee replacements have excellent survivorship, with reports of 85 to 97%. However, excellent survivorship does not equate to excellent patient reported outcomes. Total knee imbalance with either too tight or loose soft tissues account for up to 54% of revisions in one series. This may account for many of the 20% unsatisfactory total knee arthroplasty outcomes. Soft tissue balancing technique is more like an art. The surgeon relies on subjective feel for appropriate ligamentous tension. Surgical experience and case volume play a major role in each surgeon's relative skill in balancing the knee properly. New technology of “smart trials” with embedded microelectronics and accelerometers, used in the knee with the medial retinaculum closed, can provide dynamic, intraoperative feedback regarding knee quantitative compartment pressures and component tracking. After all bone cuts are made using the surgeon's preferred techniques, trial components with the sensor tibial trial are inserted and the knee is taken through a passive range of motion. After visualizing the resultant compartment pressures and tracking data on a graphical interface, imbalance situations such as a too tight MCL or ITB, an incompetent or too tight PCL, or malrotated femoral or tibial component can be identified. A decision can be made as to whether to recut the bone to realign components, do a soft tissue release, or a combination of both. Soft tissue releases can be titrated while observing equalizing compartment pressures. Sensor feedback improves soft tissue balancing. More balanced compartments occur using a sensor trial than with standard soft tissue balancing technique blinded to sensor information. A multicenter three year study has shown that having the medial and lateral compartments in flexion and extension balanced within 15 pounds provides better outcomes. Patients with quantitatively balanced TKA with <15lbf mediolateral load differential have better forgotten knee scores at six weeks and six months. Use of smart trials is a new approach to total knee replacement surgery allowing fine tune balancing and takes soft tissue balancing from art to science.
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.
Shoulder impingement is one of the most common non-traumatic upper limb causes of disability in adults. Often resulting in pain and disability, management remains highly debated. This meta-analysis of randomized trials aims to evaluate the efficacy of surgical intervention in the setting of shoulder impingement in comparison to non-operative or sham treatments. Two reviewers independently screened MEDLINE, EMBASE, PUBMED and Cochrane databases for randomized control trials published from 1946 through to May 19th, 2018. A risk of bias assessment was conducted for all included studies and outcomes were pooled using a random effects model. The primary outcome was improvement in pain up to two years. Secondary outcomes included functional outcome scores reported at the short term (/=2 years). Heterogeneity was assessed using the I2statistic. Functional outcome scores were presented along with minimal clinically important differences to provide clinical context to findings. Twelve RCT's (n=1062 patients) were included in this review. Eligible patients were a mean age of 48 (SD +/− 4) years with 45% being male gender. The pooled treatment effect of surgical intervention for shoulder impingement did not demonstrate any benefit to surgery with respect to pain relief (mean difference [MD] −0.07, 95% CI −0.40 to 0.26) or short-term functional outcomes (standardized mean difference [SMD] −0.09, 95% confidence interval [CI] −0.27 to 0.08). Surgical intervention did result in a small statistically significant but clinically unimportant improvement in long term functional outcomes (SMD 0.23, 95% CI 0.06 to 0.41). Evidence suggests surgical intervention has little, if any, benefit for impingement pathology in the middle-aged patient.
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], 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.
Fifteen-year survivorship studies demonstrate that total knee replacements have excellent survivorship, with reports of 85 to 97%. However, excellent survivorship does not equate to excellent patient reported outcomes. Noble et al. reported that 14% of their patients were dissatisfied with their outcome with more than half expressing problems with routine activities of daily living. There is also a difference in the patient's subjective assessment of outcome and the surgeon's objective assessment. Dickstein et al. reported that a third of total knee patients were dissatisfied, even though the surgeons felt that their results were excellent. Most of the patients who report lower outcome scores do so because their expectations are not being fulfilled by the total knee replacement surgery. Perhaps this dissatisfaction is a result of subtle soft tissue imbalance that we have difficulty in assessing intra-operatively and post-operatively. Soft tissue balancing techniques still rely on subjective feel for appropriate ligamentous tension by the surgeon. Surgical experience and case volume play a major role in each surgeon's relative skill in balancing the knee properly. New technology of “smart trials” with embedded microelectronics and accelerometers, used in the knee with the medial retinaculum closed, can provide dynamic, intra-operative feedback regarding knee quantitative compartment pressures and component tracking. After all bone cuts are made using the surgeon's preferred techniques, trial components with the sensor tibial trial are inserted and the knee is taken through a passive range of motion. After visualizing the resultant compartment pressures and tracking data on a graphical interface, the surgeon can decide if compartment loading differences are greater than 15 pounds whether to perform a soft tissue balance or minor bone recuts. If soft tissue balancing is chosen, pressure data can indicate where to perform the release and allow the surgeon to assess the pressure changes as titrated soft tissue releases are performed. A multi-center study using smart trials has demonstrated dramatically better outcomes out to three years.
Fifteen-year survivorship studies demonstrate that total knee replacements have excellent survivorship, with reports of 85% to 97%. However, excellent survivorship does not equate to excellent patient reported outcomes. Noble et al. reported that 14% of their patients were dissatisfied with their outcome with more than half expressing problems with routine activities of daily living. There is also a difference in the patient's subjective assessment of outcome and the surgeon's objective assessment. Dickstein et al. reported that a third of total knee patients were dissatisfied, even though the surgeons felt that their results were excellent. Most of the patients who report lower outcome scores due so because their expectations are not being fulfilled by the total knee replacement surgery. Perhaps this dissatisfaction is a result of subtle soft tissue imbalance that we have difficulty in assessing intra-operatively and post-operatively. Soft tissue balancing techniques still rely on subjective feel for appropriate ligamentous tension by the surgeon. Surgical experience and case volume play a major role in each surgeon's relative skill in balancing the knee properly. New technology of “smart trials” with embedded microelectronics and accelerometers, used in the knee with the medial retinaculum closed, can provide dynamic, intra-operative feedback regarding knee quantitative compartment pressures and component tracking. After all bone cuts are made using the surgeon's preferred techniques, trial components with the sensored tibial trial are inserted and the knee is taken through a passive range of motion. After visualizing the resultant compartment pressures and tracking data on a graphical interface, the surgeon can decide whether to perform a soft tissue balance or minor bone recuts. If soft tissue balancing is chosen, pressure data can indicate where to perform the release and allow the surgeon to assess the pressure changes as titrated soft tissue releases are performed. A multi-center study using smart trials has demonstrated dramatically better outcomes out to three years.
Fifteen-year survivorship studies demonstrate that total knee replacement have excellent survivorship, with reports of 85 to 97%. However, excellent survivorship does not equate to excellent patient reported outcomes. Noble et al. reported that 14% of their patients were dissatisfied with their outcome with more than half expressing problems with routine activities of daily living. There is also a difference in the patient's subjective assessment of outcome and the surgeon's objective assessment. Dickstein et al. reported that a third of total knee patients were dissatisfied, even though the surgeons felt that their results were excellent. Most of the patients who report lower outcome scores due so because their expectations are not being fulfilled by the total knee replacement surgery. Perhaps this dissatisfaction is a result of subtle soft tissue imbalance that we have difficulty in assessing intraoperatively and postoperatively. Soft tissue balancing techniques still rely on subjective feel for appropriate ligamentous tension by the surgeon. Surgical experience and case volume play a major role in each surgeon's relative skill in balancing the knee properly. New technology of “smart trials” with embedded microelectronics and accelerometers, used in the knee with the medial retinaculum closed, can provide dynamic, intra-operative feedback regarding knee quantitative compartment pressures and component tracking. After all bone cuts are made using the surgeon's preferred techniques, trial components with the sensored tibial trial are inserted and the knee is taken through a passive range of motion. After visualizing the resultant compartment pressures and tracking data on a graphical interface, the surgeon can decide whether to perform a soft tissue balance or a minor bone recuts. If soft tissue balancing is chosen, pressure data can indicate where to perform the release and allow the surgeon to assess the pressure changes as titrated soft tissue releases are performed. A multi-center study using smart trials has demonstrated dramatically better outcomes out to three years.