ImportanceFractures of the hip have devastating effects on function and quality of life. Intramedullary nails (IMN) are the dominant implant choice for the treatment of trochanteric fractures of... Show moreImportanceFractures of the hip have devastating effects on function and quality of life. Intramedullary nails (IMN) are the dominant implant choice for the treatment of trochanteric fractures of the hip. Higher costs of IMNs and inconclusive benefit in comparison with sliding hip screws (SHSs) convey the need for definitive evidence.ObjectiveTo compare 1-year outcomes of patients with trochanteric fractures treated with the IMN vs an SHS. Design, Setting, and ParticipantsThis randomized clinical trial was conducted at 25 international sites across 12 countries. Participants included ambulatory patients aged 18 years and older with low-energy trochanteric (AO Foundation and Orthopaedic Trauma Association [AO/OTA] type 31-A1 or 31-A2) fractures. Patient recruitment occurred between January 2012 and January 2016, and patients were followed up for 52 weeks (primary end point). Follow-up was completed in January 2017. The analysis was performed in July 2018 and confirmed in January 2022. InterventionsSurgical fixation with a Gamma3 IMN or an SHS.Main Outcomes and MeasuresThe primary outcome was health-related quality of life (HRQOL), measured by the EuroQol-5 Dimension (EQ5D) at 1-year postsurgery. Secondary outcomes included revision surgical procedure, fracture healing, adverse events, patient mobility (measured by the Parker mobility score), and hip function (measured by the Harris hip score).ResultsIn this randomized clinical trial, 850 patients were randomized (mean [range] age, 78.5 [18-102] years; 549 [64.6% female) with trochanteric fractures to undergo fixation with either the IMN (n=423) or an SHS (n=427). A total of 621 patients completed follow-up at 1 year postsurgery (304 treated with the IMN [71.9%], 317 treated with an SHS [74.2%]). There were no significant differences between groups in EQ5D scores (mean difference, 0.02 points; 95% CI, -0.03 to 0.07 points; P=.42). Furthermore, after adjusting for relevant covariables, there were no between-group differences in EQ5D scores (regression coefficient, 0.00; 95% CI, -0.04 to 0.05; P=.81). There were no between-group differences for any secondary outcomes. There were also no significant interactions for fracture stability (beta [SE] , 0.01 [0.05]; P=.82) or previous fracture (beta [SE], 0.01 [0.10]; P=.88) and treatment group.Conclusions and RelevanceThis randomized clinical trial found that IMNs for the treatment of trochanteric fractures had similar 1-year outcomes compared with SHSs. These results suggest that the SHS is an acceptable lower-cost alternative for trochanteric fractures of the hip.Trial RegistrationClinicalTrials.gov Identifier: NCT01380444 Show less
Dijkstra, H.; Oosterhoff, J.H.F.; Kuit, A. van de; Ijpma, F.F.A.; Schwab, J.H.; Poolman, R.W.; ... ; Hendrickx, L.A.M. 2023
Aims To develop prediction models using machine-learning (ML) algorithms for 90 -day and oneyear mortality prediction in femoral neck fracture (FNF) patients aged 50 years or older based on the Hip... Show moreAims To develop prediction models using machine-learning (ML) algorithms for 90 -day and oneyear mortality prediction in femoral neck fracture (FNF) patients aged 50 years or older based on the Hip fracture Evaluation with Alternatives of Total Hip arthroplasty versus Hemiarthroplasty (HEALTH) and Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH) trials.Methods This study included 2,388 patients from the HEALTH and FAITH trials, with 90 -day and oneyear mortality proportions of 3.0% (71/2,388) and 6.4% (153/2,388), respectively. The mean age was 75.9 years (SD 10.8) and 65.9% of patients (1,574/2,388) were female. The algorithms included patient and injury characteristics. Six algorithms were developed, internally validated and evaluated across discrimination (c-statistic; discriminative ability between those with risk of mortality and those without), calibration (observed outcome compared to the predicted probability), and the Brier score (composite of discrimination and calibration).Results The developed algorithms distinguished between patients at high and low risk for 90 -day and one -year mortality. The penalized logistic regression algorithm had the best performance metrics for both 90 -day (c-statistic 0.80, calibration slope 0.95, calibration intercept-0.06, and Brier score 0.039) and one -year (c-statistic 0.76, calibration slope 0.86, calibration intercept-0.20, and Brier score 0.074) mortality prediction in the hold -out set.Conclusion Using high-quality data, the ML -based prediction models accurately predicted 90 -day and one -year mortality in patients aged 50 years or older with a FNF. The final models must be externally validated to assess generalizability to other populations, and prospectively evaluated in the process of shared decision-making. Show less
Objectives: In the SPRINT trial, 18% of patients with a tibial shaft fracture (TSF) treated with intramedullary nailing (IMN) had one or more unplanned subsequent surgical procedures. It is... Show moreObjectives: In the SPRINT trial, 18% of patients with a tibial shaft fracture (TSF) treated with intramedullary nailing (IMN) had one or more unplanned subsequent surgical procedures. It is clinically relevant for surgeon and patient to anticipate unplanned secondary procedures, other than operations that can be readily expected such as reconstructive procedures for soft tissue defects. Therefore, the objective of this study was to develop a machine learning (ML) prediction model using the SPRINT data that can give individual patients and their care team an estimate of their particular probability of an unplanned second surgery. Methods: Patients from the SPRINT trial with unilateral TSFs were randomly divided into a training set (80%) and test set (20%). Five ML algorithms were trained in recognizing patterns associated with subsequent surgery in the training set based on a subset of variables identified by random forest algorithms. Performance of each ML algorithm was evaluated and compared based on (1) area under the ROC curve, (2) calibration slope and intercept, and (3) the Brier score. Results: Total data set comprised 1198 patients, of whom 214 patients (18%) underwent subsequent surgery. Seven variables were used to train ML algorithms: (1) Gustilo-Anderson classification, (2) Tscherne classification, (3) fracture location, (4) fracture gap, (5) polytrauma, (6) injury mechanism, and (7) OTA/AO classification. The best-performing ML algorithm had an area under the ROC curve, calibration slope, calibration intercept, and the Brier score of 0.766, 0.954, -0.002, and 0.120 in the training set and 0.773, 0.922, 0, and 0.119 in the test set, respectively. Conclusions: An ML algorithm was developed to predict the probability of subsequent surgery after IMN for TSFs. This ML algorithm may assist surgeons to inform patients about the probability of subsequent surgery and might help to identify patients who need a different perioperative plan or a more intensive approach. Show less
Background: Heterotopic ossification (HO) is a frequent complication following hip surgery. Using data from the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus... Show moreBackground: Heterotopic ossification (HO) is a frequent complication following hip surgery. Using data from the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemiarthroplasty (HEALTH) trial, we aimed to (1) determine the prevalence of HO following total hip arthroplasty (THA) for femoral neck fracture in patients >= 50 years of age, (2) identify whether HO is associated with an increased risk of revision surgery within 24 months after the fracture, and (3) determine the impact of HO on functional outcomes. Methods: We performed a multivariable Cox regression analysis using revision surgery as the dependent variable and HO as the independent variable. We compared Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores between participants with and those without HO at 24 months. Results: Of 1,441 participants in the study, 287 (19.9%) developed HO within 24 months. HO was not associated with subsequent revision surgery. Grade-III HO was associated with statistically significant and clinically relevant deterioration in the total WOMAC score, which was mainly related to the function component of the score, compared with grade I or II. Conclusions: The impact of grade-III HO on the functional outcomes and quality of life after THA for hip fracture is clinically important, and HO prophylaxis for selected high-risk patients may be appropriate. Show less
Objectives: This study evaluated whether patients with a left-sided femoral neck fracture (FNF) treated with a sliding hip screw (SHS) had a higher implant failure rate than patients treated for a... Show moreObjectives: This study evaluated whether patients with a left-sided femoral neck fracture (FNF) treated with a sliding hip screw (SHS) had a higher implant failure rate than patients treated for a right-sided FNF. This was performed to determine the clinical relevance of the clockwise rotational torque of the femoral neck lag screw in a SHS, in relation to the rotational stability of left and right-sided FNFs after fixation. Methods: Data were derived from the FAITH trial and Dutch Hip Fracture Audit (DHFA). Patients with a FNF, aged >= 50, treated with a SHS, with at least 3-month follow-up data available, were included. Implant failure was analyzed in a multivariable logistic regression model adjusted for age, sex, fracture displacement, prefracture living setting and functional mobility, and American Society for Anesthesiologists Class. Results: One thousand seven hundred fifty patients were included, of which 944 (53.9%) had a left-sided and 806 (46.1%) a right-sided FNF. Implant failure occurred in 60 cases (3.4%), of which 31 were left-sided and 29 right-sided. No association between fracture side and implant failure was found [odds ratio (OR) for left vs. right 0.89, 95% confidence interval (CI) 0.52-1.52]. Female sex (OR 3.02, CI: 1.62-6.10), using a mobility aid (OR 2.02, CI 1.01-3.96) and a displaced fracture (OR 2.51, CI: 1.44-4.42), were associated with implant failure. Conclusions: This study could not substantiate the hypothesis that the biomechanics of the clockwise screw rotation of the SHS contributes to an increased risk of implant failure in left-sided FNFs compared with right-sided fractures. Show less
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... Show moreAim: 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. Show less
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... Show moreObjectives: 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. Show less
Blankstein, M.; Schemitsch, E.H.; Bzovsky, S.; Poolman, R.W.; Frihagen, F.; Axelrod, D.; ... ; HEALTH Investigators 2020
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... Show moreObjectives: 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. Show less
Axelrod, D.; Comeau-Gauthier, M.; Bzovsky, S.; Schemitsch, E.H.; Poolman, R.W.; Frihagen, F.; ... ; HEALTH Investigators 2020
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... Show moreBackground: 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. Show less
Blankstein, M.; Schemitsch, E.H.; Bzovsky, S.; Axelrod, D.; Poolman, R.W.; Frihagen, F.; ... ; HEALTH Investigators 2020
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... Show moreBackground: 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 chi(2) 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. Show less
Objective: To compare the 24-month risk of mortality between arthroplasty and internal fixation for undisplaced femoral neck fractures (FNFs). Design: Retrospective cohort study. Setting: Secondary... Show moreObjective: To compare the 24-month risk of mortality between arthroplasty and internal fixation for undisplaced femoral neck fractures (FNFs). Design: Retrospective cohort study. Setting: Secondary data analysis of 2 multinational randomized controlled trials. Participants: Patients aged 50 years or older with a FNF. Intervention: Arthroplasty (n = 1441), including total hip arthroplasty and hemiarthroplasty, performed for a displaced FNF versus internal fixation (n = 734), including sliding hip screw or multiple cancellous screws, performed for an undisplaced FNF. Main Outcome Measurement: The primary outcome was mortality within 24 months of injury. Secondary outcomes included reoperation and health-related quality of life. Results: The 24-month mortality rate was 15.0% (n = 327). Arthroplasty was associated with a significant reduction in the odds of mortality [adjusted odds ratio (aOR): 0.56, 95% confidence interval (CI): 0.44-0.72, P < 0.01] compared with treatment with internal fixation. 11.4% (n = 248) of the study patients required reoperation within 24 months of injury. The odds of reoperation were 59% lower with arthroplasty treatment than with internal fixation (aOR: 0.41, 95% CI: 0.32-0.55, P < 0.01). The 24-month SF-12 physical component scores were 2.7 points higher in arthroplasty patients compared with internal fixation patients (95% CI: 1.6-3.8, P < 0.01). Conclusions: Our findings suggest arthroplasty for a FNF may reduce the risk of mortality and reoperation compared with internal fixation of undisplaced fractures. This finding is counter to many current surgical practices but consistent with a mounting body of evidence. Before widespread adoption of arthroplasty for undisplaced fractures, these results should be confirmed in a definitive comparative trial. Show less
Sivaratnam, S.; Comeau-Gauthier, M.; Sprague, S.; Schemitsch, E.H.; Poolman, R.W.; Frihagen, F.; ... ; HEALTH Investigators 2020
Background: Hip fracture trials often suffer substantial loss to follow-up due to difficulties locating and communicating with participants or when participants, or their family members, withdraw... Show moreBackground: Hip fracture trials often suffer substantial loss to follow-up due to difficulties locating and communicating with participants or when participants, or their family members, withdraw their consent. We aimed to determine which factors were associated with being unable to contact FAITH and HEALTH participants for their 24-month follow-up and to also determine which factors were associated with their withdrawal of consent. Methods: We conducted 2 multivariable logistic regression analyses to determine which factors were predictive of being unable to contact participants at 24 months postfracture and withdrawal of consent within 24 months of their fracture. Results were reported as odds ratios, 95% confidence intervals, and associated P-values. All tests were 2-tailed with alpha = 0.05. Results: We were unable to contact 123 of 2520 participants (4.9%) for their 24-month follow-up visits and 124 (4.9%) withdrew their consent from the trial. Being non-White (P = 0.003), enrolled from a non-European hospital (P < 0.001), and treated with arthroplasty (P < 0.001) were associated with an increased odds of not completing the 24-month follow-up visit. Being enrolled from a hospital in the United States (P = 0.02), from a hospital in Oceania, India, or South Africa (P < 0.001) as compared to a European hospital, and treated with arthroplasty (P < 0.001) were associated with an increased odds of consent withdrawal. Discussion: Certain factors may be predictive of loss to follow-up in hip fracture trials. We suggest that the identification of such factors may be used to inform and improve retention strategies in future orthopaedic hip fracture trials. Show less
Background: The primary objective of this study was to determine the incidence of symptomatic venous thromboembolism (VTE), including pulmonary embolism (PE) and deep vein thrombosis (DVT), in the... Show moreBackground: The primary objective of this study was to determine the incidence of symptomatic venous thromboembolism (VTE), including pulmonary embolism (PE) and deep vein thrombosis (DVT), in the hip fracture population. Secondary objectives included determining timing of VTE diagnosis, VTE thromboprophylaxis given, and identifying any factors associated with VTE. Methods: Using data from the FAITH and HEALTH trials, the incidence of VTE, including DVT and PE, and the timing of VTE were determined. A multivariable Cox regression analysis was used to determine which factors were associated with increased risk of VTE, including age, treatment for comorbidity, thromboprophylaxis, time to surgery, and method of fracture management. Results: 2520 hip fracture patients were included in the analysis. Sixty-four patients (2.5%) had a VTE [DVT: 36 (1.4%), PE: 28 (1.1%)]. Thirty-five (54.7%) were diagnosed less than 6 weeks postfracture and 29 (45.3%) more than 6 weeks postfracture. One thousand nine hundred ninety-three (79%) patients received thromboprophylaxis preoperatively and 2502 (99%) received thromboprophylaxis postoperatively. The most common method of preoperative (46%) and postoperative (73%) thromboprophylaxis was low molecular weight heparin. Treatment with arthroplasty compared to internal fixation was the only variable associated with increased risk of VTE (hazard ratio 2.67, P = 0.02). Conclusions: The incidence of symptomatic VTE in hip fracture patients recruited to the 2 trials was 2.5%. Although over half of the cases were diagnosed within 6 weeks of fracture, VTE is still prevalent after this period. The majority of patients received thromboprophylaxis. Treatment with arthroplasty rather than fixation was associated with increased incidence of VTE. Show less
