AimsUsing data from the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty ver-sus Hemiarthroplasty (HEALTH) trial, we sought to determine if a difference in functional outcomes... Show moreAimsUsing data from the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty ver-sus Hemiarthroplasty (HEALTH) trial, we sought to determine if a difference in functional outcomes exists between monopolar and bipolar hemiarthroplasty (HA).MethodsThis study is a secondary analysis of patients aged 50 years or older with a displaced femoral neck fracture who were enrolled in the HEALTH trial and underwent monopolar and bipolar HA. Scores from the Western Ontario and McMaster University Arthritis Index (WOMAC) and 12 -Item Short Form Health Survey (SF -12) Physical Component Summary (PCS) and (MCS) were compared between the two HA groups using a propensity score-weighted analysis.ResultsOf 746 HAs performed in the HEALTH trial, 404 were bipolar prostheses and 342 were uni-polar. After propensity score weighting, adequate balance between the bipolar and unipo-lar groups was obtained as shown by standardized mean differences less than 0.1 for each covariable. A total of 24 months after HA, the total WOMAC score and its subcomponents showed no statistically significant difference between the unipolar and bipolar groups. Sim-ilarly, no statistically significant difference was found in the PCS and MCS scores of the SF -12 questionnaire. In participants aged 70 years and younger, no difference was found in any of the functional outcomes.ConclusionFrom the results of this study, the use of bipolar HA over unipolar design does not provide superior functional outcomes at 24 months postoperatively. The theoretical advantage of reduced acetabular wear with bipolar designs does not appear to influence functional out-comes in the first two years postoperatively. Cite this article: Bone Jt Open 2023;4-5:370-377. 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
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
