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1.
Injury ; 2021 Feb 14.
Artigo em Inglês | MEDLINE | ID: mdl-33618847

RESUMO

PURPOSE: Femoral neck fractures in young patients are typically managed with internal fixation using either cancellous screws or a sliding hip screw (SHS). Although fixation preserves the hip joint, patients are still at risk of complications and poor clinical outcomes which lead to diminished function and health related quality of life (HRQL). The Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH-2) pilot randomized controlled factorial trial evaluated the effect of surgical fixation (cancellous screws vs. SHS) and vitamin D supplementation vs. placebo on patient-reported function and HRQL. METHODS: Patients between the ages of 18-60 years with a femoral neck fracture requiring surgical fixation were eligible. Eligible patients were randomized to receive either a sliding hip screw or cancellous screws for fracture fixation AND vitamin D3 4,000 IU or placebo daily for 6 months. Patient-reported function (Hip Outcome Score) and HRQL (Short Form-12) were assessed at standardized time points in the 12 months following their fixation surgery. Patient-reported function and HRQL were summarized using means, SD, and 95% confidence intervals (CIs), or percentages and counts. Longitudinal data analysis with mixed models was used to explore the effect of treatment group and time on the patient-reported function and HRQL. RESULTS: 86 of the 91 patients randomized into the FAITH-2 pilot study were deemed eligible. There were no significant differences in patient-reported function or HRQL between the treatment groups at 12 months post-fracture. At the 6- and 9-month assessments, a potential benefit in hip function was seen in the cancellous screw group. In all treatment groups, participants reported lower function and HRQL at 12 months post-fracture as compared to their pre-injury assessment. CONCLUSIONS: Few differences were found in function and HRQL among the treatment groups in the FAITH-2 pilot study. Despite modern implants and vitamin D supplementation, neither function nor HRQL returns to baseline in this population. Additional efforts to improve the outcomes of these challenging injuries are still needed. LEVEL OF EVIDENCE: Therapeutic Level II.

2.
Pain Res Manag ; 2021: 8857948, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33613794

RESUMO

Purpose: Medical cannabis for patients with chronic noncancer pain (CNCP) has been the focus of numerous health care recommendations. We conducted a systematic review to identify and summarize the currently available evidence-based recommendations. Methods: We searched MEDLINE, EMBASE, PsycINFO, the Cochrane database of systematic reviews, and websites for clinical guidelines and recommendations. We summarized the type of the publications, developers, approach of health care recommendation development, year and country of publication, and conditions that were addressed. We categorized the direction and strength of each recommendation. Results: We identified 12 eligible publications. Publication years ranged from 2007 to 2019; four (33.3%) of them were published in 2018. Canada ranked first for the number of publications (n = 4, 33.3%). Most (n = 11, 92%) of the included recommendations were based on both a systematic review of the best evidence and expert consensus. All the included publications provided a recommendation supporting medical cannabis for CNCP in general and for the specific conditions of neuropathic pain, chronic pain in people living with Human Immunodeficiency Virus (HIV), and chronic abdominal pain, with detailed information sharing and comprehensive consideration of a patient's own values and preferences. Conclusion: Clinicians can attend to the guidance currently offered, being aware that only weak recommendations are available for medical cannabis in patients with CNCP, as a third- or fourth-line therapy. Detailed discussions with patients regarding the benefits in reducing pain and potential adverse effects are required before its prescription.

3.
Contemp Clin Trials Commun ; 21: 100730, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33605946

RESUMO

Introduction: Pragmatic trials in comparative effectiveness research assess the effects of different treatment, therapeutic, or healthcare options in clinical practice. They are characterized by broad eligibility criteria and large sample sizes, which can lead to an unmanageable number of participants, increasing the risk of bias and affecting the integrity of the trial. We describe the development of a sampling strategy tool and its use in the PREPARE trial to circumvent the challenge of unmanageable work flow. Methods: Given the broad eligibility criteria and high fracture volume at participating clinical sites in the PREPARE trial, a pragmatic sampling strategy was needed. Using data from PREPARE, descriptive statistics were used to describe the use of the sampling strategy across clinical sites. A Chi-square test was performed to explore whether use of the sampling strategy was associated with a reduction in the number of missed eligible patients. Results: 7 of 20 clinical sites (35%) elected to adopt a sampling strategy. There were 1539 patients excluded due to the use of the sampling strategy, which represents 30% of all excluded patients and 20% of all patients screened for participation. Use of the sampling strategy was associated with lower odds of missed eligible patients (297/4545 (6.5%) versus 341/3200 (10.7%) p < 0.001). Conclusions: Implementing a sampling strategy in the PREPARE trial has helped to limit the number of missed eligible patients. This sampling strategy represents a simple, easy to use tool for managing work flow at clinical sites and maintaining the integrity of a large trial.

5.
BMJ Open ; 11(2): e041129, 2021 Feb 05.
Artigo em Inglês | MEDLINE | ID: mdl-33550239

RESUMO

INTRODUCTION: High tibial osteotomy (HTO) is a treatment of choice for active adult with knee osteoarthritis. With advancement in CT imaging with three-dimensional (3D) model reconstruction, virtual planning and 3D printing, patient-specific instrumentation (PSI) in form of cutting jigs is employed to improve surgical accuracy and outcome of HTO. The aim of this randomised controlled trial (RCT) is to explore the surgical outcomes of HTO for the treatment of medial compartment knee osteoarthritis with or without a 3D printed patient-specific jig. METHODS AND ANALYSIS: A double-blind RCT will be conducted with patients and outcome assessors blinded to treatment allocation. This meant that neither the patients nor the outcome assessors would know the actual treatment allocated during the trial. Thirty-six patients with symptomatic medial compartment knee osteoarthritis fulfilling our inclusion criteria will be invited to participate the study. Participants will be randomly allocated to one of two groups (1:1 ratio): operation with 3D printed patient-specific jig or operation without jig. Measurements will be taken before surgery (baseline) and at postoperatively (6, 12 and 24 months). The primary outcome includes radiological accuracy of osteotomy. Secondary outcomes include a change in knee function from baseline to postoperatively as measured by three questionnaires: Knee Society Scores (Knee Scores and Functional Scores), Oxford Knee Scores and pain visual analogue scale (VAS) score. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee (CREC no. 2019.050), in accordance with the Declaration of Helsinki. The results will be presented at international scientific meetings and through publications in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04000672; Pre-results.

6.
Artigo em Inglês | MEDLINE | ID: mdl-33398481

RESUMO

PURPOSE: To identify patient factors associated with improved pain scores, functional hip scores, health-related quality of life, and re-operation rates after arthroscopic management of femoroacetabular impingement (FAI). METHODS: Using the comprehensive dataset from the multinational Femoroacetabular Impingement Randomized Controlled Trial (FIRST), a total of 13 prognostic factors that were chosen a priori were identified that would be expected to predict post-surgical outcomes. The primary outcome was pain assessed using a Visual Analogue Scale (VAS) and secondary outcomes included hip function (Hip Outcome Score [HOS] and International Hip Outcome Tool [iHOT-12]), health-related quality of life (Short Form-12 [SF-12] and Euro-Qol 5 Dimensions [EQ-5D]), and re-operation rate. A multivariable linear regression was used to analyse the change questionnaire scores from baseline to 12 months post-surgery including all 13 prognostic factors as independent variables. A total of 27 re-operation events were analysed at 24 months using a multivariable logistic regression including only the treatment group variable. RESULTS: Of the 154 patients that had VAS scores completed at 12 months, a lower BMI (adjusted mean difference [aMD], 4.48 for a 5-unit decrease in BMI; 95% confidence interval [CI] 0.33-8.63; p = 0.035) was significantly associated with less pain. There was a significant negative association between increasing age and 1-year EQ-5D scores (aMD, - 0.04 for every 10-year increase in age; 95% CI - 0.07 to - 0.006; p = 0.020). The degree of impingement, severity of osteoarthritis, type of procedure, and adjudicated quality of surgery were not significantly associated with improvement across all outcomes at 12 months. Furthermore, there was no significant association between the treatment variable and the incidence of re-operation at 24 months. CONCLUSION: This study identified that lower BMI and age are predictive of improved pain and health utility scores, respectively, following arthroscopic management of FAI at 12 months post-surgery. These results may be a helpful adjunct in clinical decisions for this patient population when determining candidacy for surgical intervention. LEVEL OF EVIDENCE: I.

7.
J Bone Joint Surg Am ; Publish Ahead of Print2021 Jan 07.
Artigo em Inglês | MEDLINE | ID: mdl-33411466

RESUMO

BACKGROUND: Prompt administration of antibiotics is a critical component of open fracture treatment. Traditional antibiotic recommendations have been a first-generation cephalosporin for Gustilo Type-I and Type-II open fractures, with the addition of an aminoglycoside for Type-III fractures and penicillin for soil contamination. However, concerns over changing bacterial patterns and the side effects of aminoglycosides have led to interest in other regimens. The purpose of the present study was to describe the adherence to current prophylactic antibiotic guidelines. METHODS: We evaluated the antibiotic-prescribing practices of 24 centers in the U.S. and Canada that were participating in 2 randomized controlled trials of skin-preparation solutions for open fractures. A total of 1,234 patients were evaluated. RESULTS: All patients received antibiotics on the day of admission. The most commonly prescribed antibiotic regimen was cefazolin monotherapy (53.6%). Among patients with Type-I and Type-II fractures, there was 61.1% compliance with cefazolin monotherapy. In contrast, only 17.2% of patients with Type-III fractures received the recommended cefazolin and aminoglycoside therapy, with an additional 6.7% receiving piperacillin/tazobactam. CONCLUSIONS: There is moderate adherence to the traditional antibiotic treatment guidelines for Gustilo Type-I and Type-II fractures and low adherence for Type-III fractures. Given the divergence between current practice patterns and prior recommendations, high-quality studies are needed to determine the most appropriate prophylactic protocol.

8.
J Clin Epidemiol ; 133: 61-71, 2020 Dec 13.
Artigo em Inglês | MEDLINE | ID: mdl-33321175

RESUMO

OBJECTIVES: The objective of the study was to develop an inventory summarizing all anchor-based minimal important difference (MID) estimates for patient-reported outcome measures (PROMs) available in the medical literature. STUDY DESIGN AND SETTING: We searched MEDLINE, EMBASE, CINAHL, PsycINFO, and the Patient-Reported Outcome and Quality of Life Instruments Database internal library (January 1989-October 2018). We included primary studies empirically calculating an anchor-based MID estimate for any PROM in adults and adolescents. Pairs of reviewers independently screened and selected studies, extracted data, and evaluated the credibility of the MIDs. RESULTS: We identified 585 eligible studies, the majority conducted in Europe (n = 211) and North America (n = 179), reporting 5,324 MID estimates for 526 distinct PROMs. Investigators conducted their studies in the context of patients receiving surgical (n = 105, 18%), pharmacological (n = 85, 15%), rehabilitation (n = 65, 11%), or a combination of interventions (n = 194, 33%). Of all MID estimates, 59% (n = 3,131) used a global rating of change anchor. Major credibility limitations included weak correlation (n = 1,246, 23%) or no information regarding the correlation (n = 3,498, 66%) between the PROM and anchor and imprecision in the MID estimate (n = 2,513, 47%). CONCLUSION: A large number of MIDs for assisting in the interpretation of PROMs exist. The MID inventory will facilitate the use of MID estimates to inform the interpretation of the magnitude of treatment effects in clinical research and guideline development.

9.
Artigo em Inglês | MEDLINE | ID: mdl-33196584

RESUMO

BACKGROUND: Forty percent of long bone fractures involve the tibia. These fractures are associated with prolonged recovery and may adversely affect patients' long-term physical functioning; however, there is limited evidence to inform what factors influence functional recovery in this patient population. QUESTION/PURPOSE: In a secondary analysis of a previous randomized trial, we asked: What fracture-related, demographic, social, or rehabilitative factors were associated with physical function 1 year after reamed intramedullary nailing of open or closed tibial shaft fractures? METHODS: This is a secondary (retrospective) analysis of a prior randomized trial (Trial to Re-evaluate Ultrasound in the Treatment of Tibial Fractures; TRUST trial). In the TRUST trial, 501 patients with unilateral open or closed tibial shaft fractures were randomized to self-administer daily low-intensity pulsed ultrasound or use a sham device, of which 15% (73 of 501) were not followed for 1 year due to early study termination as a result of futility (no difference between active and sham interventions). Of the remaining patients, 70% (299 of 428) provided full data. All fractures were fixed using reamed (298 of 299) or unreamed (1 of 299) intramedullary nailing. Thus, we excluded the sole fracture fixed using unreamed intramedullary nailing. The co-primary study outcomes of the TRUST trial were time to radiographic healing and SF-36 physical component summary (SF-36 PCS) scores at 1-year. SF-36 PCS scores range from 0 to 100, with higher scores being better, and the minimum clinically important difference (MCID) is 5 points. In this secondary analysis, based on clinical and biological rationale, we selected factors that may be associated with physical functioning as measured by SF-36 PCS scores. All selected factors were inserted simultaneously into a multivariate linear regression analysis. RESULTS: After adjusting for potentially confounding factors, such as age, gender, and injury severity, we found that no factor showed an association that exceeded the MCID for physical functioning 1 year after intramedullary nailing for tibial shaft fractures. The independent variables associated with lower physical functioning were current smoking status (mean difference -3.0 [95% confidence interval -5 to -0.5]; p = 0.02), BMI > 30 kg/m (mean difference -3.0 [95% CI -5.0 to -0.3]; p = 0.03), and receipt of disability benefits or involvement in litigation, or plans to be (mean difference -3.0 [95% CI -5.0 to -1]; p = 0.007). Patients who were employed (mean difference 4.6 [95% CI 2.0 to 7]; p < 0.001) and those who were advised by their surgeon to partially or fully bear weight postoperatively (mean difference 2.0 [95% CI 0.1 to 4.0]; p = 0.04) were associated with higher physical functioning. Age, gender, fracture severity, and receipt of early physical therapy were not associated with physical functioning at 1-year following surgical fixation. CONCLUSION: Among patients with tibial fractures, none of the factors we analyzed, including smoking status, receipt of disability benefits or involvement in litigation, or BMI, showed an association with physical functioning that exceeded the MCID. LEVEL OF EVIDENCE: Level III, therapeutic study.

10.
Bone Rep ; 13: 100728, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33145376

RESUMO

Objective: Teriparatide has been increasingly utilized in the management of osteoporosis. The efficacy of low and high dose teriparatide on lumbar spine bone mineral density, vertebral fracture incidence and pain is unknown. We sought to determine the efficacy of teriparatide on these patient-important outcomes using a systematic review and meta-analysis. Methods: A systematic search of electronic databases (MEDLINE, EMBASE, CENTRAL, CINAHL) was performed to identify randomized controlled trials (RCTs) that evaluate teriparatide to any comparator for the treatment of osteoporosis in postmenopausal women. The Grades of Recommendation Assessment, Development and Evaluation (GRADE) criteria were used by two independent reviewers to assess the strength and quality of evidence. Results: A total of 20 studies (n = 6024) were included in this review, with 2855 patients receiving teriparatide and 3169 patients receiving placebo or control treatment. A teriparatide dose of 20 µg/day increased lumbar spine bone mineral density (BMD) (standardized mean difference (SMD) 0.34 standard deviation (SD) units higher (95% CI 0.19-0.48 SDs higher) in comparison to placebo. Relative to anti-resorptive agents, 20 µg/day of teriparatide had a range from 0.14 SD units to 0.96 SD units higher (95% CI, 0.08 SDs lower to 0.36 SDs higher, CI, 0.33-1.59 SDs higher, respectively). 20 µg/day teriparatide had a significant effect on pain severity to placebo or control (SMD 0.80, 95% CI, 1.16-0.43 SDs lower) and also decreased the incidence of vertebral fractures compared to placebo (relative risk 0.31, 95% CI 0.21 to 0.46). Arthralgia and extremity pain incidence were also calculated; there were 15 and 8 fewer events per 1000 patients with the use of 20 µg/day of teriparatide compared to placebo or control, respectively. Conclusion: High quality evidence supports the utilization of teriparatide 20 µg/day dose to significantly improve lumbar spine BMD and decrease incidence of vertebral fractures and pain severity relative to all comparators. 40 µg/day dose of teriparatide demonstrated significantly better results with prolonged treatment. This data is valuable for clinicians involved in the care of this growing demographic of patients. Further investigation on the safety and efficacy of teriparatide in higher doses for the long-term treatment of osteoporosis in postmenopausal women should be conducted through high-quality clinical trials.

11.
Artigo em Inglês | MEDLINE | ID: mdl-33104869

RESUMO

BACKGROUND: Infection is a truly devastating complication of total joint arthroplasty, causing most patients to undergo a revision surgery, and to bear significant psychological and financial burden. The purpose of this study is to systematically evaluate the literature to determine the efficacy and complication profile of local antibiotic application in primary total joint arthroplasty. METHODS: All studies of primary total joint arthroplasty which assessed local antibiotics in any form other than antibiotic-impregnated cement as an intervention were included. Studies that reported at least one outcome related to infection and were available in full text in English were eligible for inclusion. Studies which included both primary and revision cases but did not report the stratified data for each type of surgery and studies on fracture populations were excluded. RESULTS: A total of 9 studies involving 3,714 cases were included. The pooled deep infection rate was 1.6% in the intervention groups and 3.5% in the control groups. Meta-analysis revealed a RR of 0.53 (95%CI: 0.35-0.79, p = 0.002) with no heterogeneity (I2 = 0%) for infection in the intervention groups. Meta-analysis revealed a non-significant reduction in superficial infection rates in the intervention groups; however, there was a significant increase in aseptic wound complications in the intervention groups. CONCLUSION: Local antibiotic application results in a moderate reduction in deep infection rates in primary total joint arthroplasty, with no significant impact on superficial infection rates. However, local antibiotic application may be associated with a moderate increase in aseptic wound complications.

12.
J Orthop Trauma ; 2020 Oct 21.
Artigo em Inglês | MEDLINE | ID: mdl-33105456

RESUMO

BACKGROUND: Many studies report on the incidence or prevalence of fracture-related surgical site infections (SSIs) following open fractures; however, few studies report on their timing, and management outcomes. To address this gap, we used data from the FLOW trial to determine timing of diagnosis, management, and resolution of SSIs. METHODS: All participants included in this analysis had an SSI after an open fracture. Participants were assigned to a group based on the type of SSI: 1) those who developed a superficial SSI; and 2) those who had either a deep or organ/space SSI. Descriptive statistics characterized the type, timing, and management of each SSI. RESULTS: Of the 2,445 participants in the FLOW trial, 325 (13.3%) had an SSI. Superficial SSIs were diagnosed significantly earlier (26.5 days, interquartile range (IQR) 12-48) than deep or organ/space SSIs (53 days, IQR 15-119). Of the 325 patients with SSIs, 174 required operative management and 151 were treated non-operatively. For SSIs managed operatively, median time for infection resolution was 73 days (IQR 28-165) and on average, 1.73 surgeries (95% CI 1.58-1.88) were needed during the 12 months follow-up. There were 24 cases whose SSIs were not resolved at the time of the final follow-up visit (12 months). CONCLUSIONS: Based on this study's findings, and in contra-distinction to the CDC guidelines, after an open fracture, superficial SSIs were diagnosed at one month, and deep/organ/space SSIs at two months. This information can allow for earlier infection detection. In addition, the knowledge that approximately 50% of the SSIs in our study required a re-operation and three months at a minimum to resolve, will assist orthopaedic surgeons when counseling their patients. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

13.
J Bone Joint Surg Am ; 102(20): e116, 2020 Oct 21.
Artigo em Inglês | MEDLINE | ID: mdl-33086352

RESUMO

BACKGROUND: The quality of reporting of randomized controlled trials (RCTs) published in The Journal of Bone & Joint Surgery (JBJS) from 1988 to 2000 was previously analyzed. The purpose of this current study was to analyze the quality of reporting of RCTs published in JBJS from 2001 to 2013 to identify trends over time and potential areas of improvement for future clinical trials. METHODS: A manual search of the JBJS database identified RCTs published between January 2001 and December 2013. Quality assessments, using the Detsky quality-of-reporting index (Detsky score), a modified Cochrane risk-of-bias tool, and abstraction of relevant data identifying predictors of quality, were conducted. RESULTS: A total of 5,780 publications were identified in JBJS from 2001 to 2013, with 285 RCTs (4.9%), representing an increase from the prior 13-year period. The overall mean transformed Detsky score (and standard error) increased significantly (p < 0.001) from 68.1% ± 1.67% to 76.24% ± 0.72%. The percentage of multicenter RCTs decreased from 67% to 31%. The percentage of positive trials also decreased from 80% to 50.5%, as did the mean sample size (212 to 166). Regression analysis indicated that trials with an epidemiologist as the first author and nonsurgical trials were significantly associated (p = 0.001) with a higher overall trial quality score. The categories of the lowest mean methodology scores were randomization and concealment, eligibility criteria, and reasons for patient exclusion, as identified with the Detsky score, and patient and assessor blinding, as identified with the risk-of-bias assessment. CONCLUSIONS: The quantity and quality of published RCTs in JBJS have increased in the 2001 to 2013 time period compared with the previous time period. Although these improvements are encouraging, trends to smaller, single-center trials were also observed. To efficiently determine the efficacy of orthopaedic treatments and limit bias, high-quality randomized trials of appropriate sample size and rigorous design are needed.

14.
J Orthop Trauma ; 34 Suppl 3: S29-S36, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33027163

RESUMO

BACKGROUND: Total hip arthroplasty (THA) has been argued to improve health-related quality of life (HRQoL) and function in femoral neck fracture patients compared with hemiarthroplasty (HA). The HEALTH trial showed no clinically important functional advantages of THA over HA. The current analysis explores factors associated with HRQoL and function in this population. METHODS: Using repeated measures regression, we estimated the association between HRQoL and function [Short Form-12 (SF-12) physical component score (PCS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score] and 23 variables. RESULTS: THA as compared to monopolar HA, but not bipolar HA, was more likely to improve PCS scores (adjusted mean difference [AMD] 1.88 points, P = 0.02), whereas higher American Society of Anesthesiologists score (AMD -2.64, P < 0.01), preoperative use of an aid (AMD -2.66, P < 0.01), and partial weight-bearing status postoperatively (AMD -1.38, P = 0.04) demonstrated less improvement of PCS scores over time. THA improved WOMAC function scores over time compared with monopolar HA (but not bipolar HA) (AMD -2.40, P < 0.01), whereas higher American Society of Anesthesiologists classification (AMD 1.99, P = 0.01) and preoperative use of an aid (AMD 5.39, P < 0.01) were associated with lower WOMAC function scores. Preoperative treatment for depression was associated with lower functional scores (AMD 7.73, P < 0.01). CONCLUSION: Patients receiving THA are likely to receive small and clinically unimportant improvements in health utility and function compared with those receiving monopolar HA and little improvement compared with those receiving bipolar HA. Patient-specific characteristics seem to play a larger role in predicting functional improvement among femoral neck fracture patients. LEVEL OF EVIDENCE: Prognostic Level II.

15.
J Orthop Trauma ; 34 Suppl 3: S37-S41, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33027164

RESUMO

BACKGROUND: Displaced femoral neck fractures are a significant source of morbidity and mortality and can be treated with either hemiarthroplasty (HA) or total hip arthroplasty (THA). Proponents of THA have argued THA offers lower risk of revision, with improved functional outcomes when compared to HA. To evaluate cost effectiveness of THA compared with HA, a trial-based economic analysis of the HEALTH study was undertaken. METHODS: Health care resource utilization (HRU) and health-related quality of life (HRQoL) data were collected postoperatively and costed using publicly available databases. Using EuroQol-5 Dimensions (EQ-5D) scores, we derived quality adjusted life years (QALYs). A 1.5% discount rate to both costs and QALYs was applied. Age analyses per age group were conducted. All costs are reported in 2019 Canadian dollars. RESULTS: When compared with HA, THA was not cost-effective for all patients with displaced femoral neck fractures ($150,000/QALY gained). If decision makers were willing to spend $50,000 or $100,000 to gain one QALY, the probability of THA being cost-effective was 12.8% and 32.8%, respectively. In a subgroup of patients younger than 73 (first quartile), THA was both more effective and less costly. Otherwise, THA was more expensive and yielded marginal HRQoL gains. CONCLUSIONS: Our results suggest that for most patients, THA is not a cost-effective treatment for displaced femoral neck fracture management versus HA. However, THA may be cost effective for younger patients. These patients experience more meaningful improvements in quality of life with less associated cost because of shorter hospital stay and fewer postoperative complications. LEVEL OF EVIDENCE: Economic Level II. See Instructions for Authors for a complete description of levels of evidence.

16.
J Orthop Trauma ; 34 Suppl 3: S64-S69, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33027168

RESUMO

OBJECTIVES: This study compares outcomes for patients with displaced femoral neck fractures undergoing hemiarthroplasty (HA) or total hip arthroplasty (THA) by surgeons of different fellowship training. DESIGN: Retrospective review of HEALTH trial data. SETTING: Eighty clinical sites across 10 countries. PATIENTS/PARTICIPANTS: One thousand four hundred forty-one patients ≥50 years with low-energy hip fractures requiring surgical intervention. INTERVENTION: Patients were randomized to either HA or THA groups in the initial data set. Surgeons' fellowship training was ascertained retrospectively, and outcomes were compared. MAIN OUTCOME MEASUREMENTS: The main outcome was an unplanned secondary procedure at 24 months. Secondary outcomes included death, serious adverse events, prosthetic joint infection (PJI), dislocation, discharge disposition, and use of ambulatory devices postoperatively. RESULTS: There was a significantly higher risk of PJI in patients treated by surgeons without fellowship training in arthroplasty (P = 0.01), surgeons with unknown fellowship training (P = 0.03), and surgeons with no fellowship training (P = 0.02) than those treated by an arthroplasty-trained surgeon. There were significantly higher odds of being discharged to a facility rather than home in patients who underwent surgery by a surgeon with no fellowship training compared with arthroplasty-fellowship-trained surgeons (P = 0.03). CONCLUSIONS: Arthroplasty for hip fracture can be performed by all orthopaedic surgeons with equivalent reoperation rates. Infection prevention strategies and use of "care pathways" by arthroplasty-fellowship-trained surgeons may account for the lower risk of PJI and higher rate of discharge to home. The authors advocate for the use of evidence-based infection prevention initiatives and standardized care pathways in this patient population. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

17.
J Orthop Trauma ; 34 Suppl 3: S55-S63, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33027167

RESUMO

OBJECTIVES: To identify factors associated with the development of prolonged pain after hip fracture surgery. DESIGN: Secondary analysis of a randomized controlled trial. SETTING: Eighty hospitals in 10 countries. PATIENTS/PARTICIPANTS: One thousand four hundred forty-one hip fracture patients in the HEALTH trial. INTERVENTIONS: Total hip arthroplasty or hemiarthroplasty. MAIN OUTCOME MEASURES: Moderate-to-severe pain (at least 2 activities on the Western Ontario and McMaster Universities Osteoarthritis questionnaire pain subscale with scores ≥2) at 12 and 24 months after hip arthroplasty. RESULTS: Of 840 and 726 patients with complete baseline data and outcomes at 1-year and 2-year follow-up, 96 (11.4%) and 80 (11.0%) reported moderate-to-severe pain, respectively. An increased risk of pain at both 1 and 2 years after surgery was associated with reporting moderate-to-severe hip pain before fracture [absolute risk increase (ARI) 15.3%, 95% confidence interval (CI) 6.44%-24.35%; ARI 12.5%, 95% CI 2.85%-22.12%, respectively] and prefracture opioid use (ARI 15.6%, 95% CI 5.41%-25.89%; ARI 21.1%; 95% CI 8.23%-34.02%, respectively). Female sex was associated with an increased risk of persistent pain at 1 year (ARI 6.2%, 95% CI 3.53%-8.84%). A greater risk of persistent pain at 2 years was associated with younger age (≤79-year-old; ARI 6.3%; 95% CI 2.67%-9.91%) and higher prefacture functional status (ARI 10.7%; 95% CI 3.80%-17.64%). CONCLUSIONS: Among hip fracture patients undergoing arthroplasty, approximately one in 10 will experience moderate-to-severe pain up to 2 years after surgery. Younger age, female sex, higher functioning prefracture, living with hip pain prefracture, and use of prescription opioids were predictive of persistent pain. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

18.
J Orthop Trauma ; 34 Suppl 3: S49-S54, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33027166

RESUMO

OBJECTIVES: HEALTH was a randomized controlled trial comparing total hip arthroplasty with hemiarthroplasty in low-energy displaced femoral neck fracture patients aged ≥50 years with unplanned revision surgery within 24 months of the initial procedure being the primary outcome. No significant short-term differences between treatment arms were observed. The primary objective of this secondary HEALTH trial analysis was to determine if any patient and surgical factors were associated with increased risk of revision surgery within 24 months after hip fracture. METHODS: We analyzed 9 potential factors chosen a priori that could be associated with revision surgery. The factors included age, body mass index, major comorbidities, independent ambulation, type of surgical approach, length of operation, use of femoral cement, femoral head size, and degree of femoral stem offset. Our statistical analysis was a multivariable Cox regression using reoperation within 24 months of index surgery as the dependent variable. RESULTS: Of the 1441 patients included in this analysis, 8.1% (117/1441) experienced reoperation within 24 months. None of the studied factors were found to be predictors of revision surgery (P > 0.05). CONCLUSION: Both total and partial hip replacements are successful procedures in low-energy displaced femoral neck fracture patients. We were unable to identify any patient or surgeon-controlled factors that significantly increased the need for revision surgery in our elderly and predominately female patient population. One should not generalize our findings to an active physiologically younger femoral neck fracture population. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

19.
J Orthop Trauma ; 34 Suppl 3: S1-S8, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33027159

RESUMO

BACKGROUND: Over the past decade, 2 randomized controlled trials were performed to evaluate 2 surgical strategies (internal fixation and arthroplasty) for the treatment of low-energy femoral neck fractures in patients aged ≥50 years. We evaluated whether patient populations in both the FAITH and HEALTH trials had different baseline characteristics and compared the displaced femoral neck fracture cohort from the FAITH trial to HEALTH trial patients. METHODS: Patient demographics, medical comorbidities, and fracture characteristics from both trials were compared. FAITH trial patients with displaced fractures were then compared with HEALTH patients. T-tests and χ tests were performed to compare differences for sex, age, osteoporosis status, and ASA class. RESULTS: The mean age of the 1079 FAITH trial patients was 72 versus 79 years for the 1441 HEALTH trial patients. HEALTH patients were older, mostly White, used more medication, and had more comorbidities than FAITH patients. Of the 1079 FAITH trial patients, 32% (346/1079) had displaced fractures. Their mean age was significantly lower than that of HEALTH patients (66 vs. 79 years; P < 0.001). HEALTH trial patients were significantly more likely to be female, have ASA classification Class III/IV/V, and carry a diagnosis of osteoporosis, as compared with the subgroup of FAITH patients with displaced femoral neck fractures (P < 0.001). CONCLUSION: This study demonstrates significant differences between patients enrolled in the 2 trials. Although both studies focused on femoral neck fractures with similar enrollment criteria, patient populations differed. This sheds light on a noteworthy limitation of discordant patient enrollment into randomized trials, despite similar eligibility criteria. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

20.
J Orthop Trauma ; 34 Suppl 3: S42-S48, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33027165

RESUMO

AIM: Patients with hip fractures are often frail with multiple comorbidities and at risk of medical serious adverse events (SAEs). We investigated the HEALTH trial patient population to ascertain predictors of SAEs. METHODS: We performed a multivariable Cox regression analysis. Occurrence of SAEs was included as the dependent variable with 31 potential prognostic factors being included as independent variables. RESULTS: One thousand four hundred forty-one patients were included in this analysis. Three hundred seventy (25.6%) patients suffered from an SAE. The most common events were cardiac (38.4%, n = 105), respiratory (20.8%, n = 77), and neurological (14.1%, n = 77). The majority of SAEs (50.8%, n = 188) occurred in the first 90 days after hip fracture with 35.4% occurring in the first 30 days (n = 131). Body mass index (BMI) between 18.5 and 24.9 compared with BMI between 25 and 29.9 [hazard ratio (HR) 1.32, P = 0.03] and receiving a total hip arthroplasty compared with a bipolar hemiarthroplasty (HR 1.36, P = 0.03) were associated with a higher risk of a medical SAE within 24 months of femoral neck fracture. Age (P = 0.09), use of femoral cement (P = 0.59), and use of canal pressurization (P = 0.37) were not associated with a medical SAE. CONCLUSION: Total hip arthroplasty is associated with more SAEs in the immediate postoperative period, and care should be taken in selecting patients for this treatment compared with a hemiarthroplasty. A higher BMI may be protective in hip fracture patients while age alone does not predict SAEs and neither does the use of femoral cement and/or pressurization. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

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