Teriparatide seems to improve recovery after pertrochanteric hip fracture : Comparison with risedronate in a randomized, controlled trial

To compare the effects on fracture recovery of 26 wks' therapy with an oral antiresorptive (risedronate: RIS 35 mg QW) or a bone forming drug (teriparatide: TPTD 20 ug QD) started within 2 wks after osteosynthesis in a pertrochanteric hip fracture in patients with low bone mass. Methods: 224 patients were randomized to study drug and an oral/injectable placebo plus calcium/vitD3 in an osteoporosis trial. The primary outcome was bone mineral density which will be reported elsewhere. We report secondary (Timed Up-and-Go [TUG] test, hip pain, SF-36, safety) and exploratory (radiography) endpoints. Efficacy analyses of the TUG test, patient-rated health status, and hip pain 100 mm Visual Analog Scale were performed with a Mixed-effects Model for Repeated Measures. Results: Mean age was 77 years and 77% were female. The teriparatide group completed the TUG test in a shorter time (LS means 5.7, 4.4, 3.1, and 3.1 seconds less at 6, 12, 18, and 24 wks; overall difference p = 0.021) and reported less hip pain during the test (LS means 8.7, 10.6, 11.9, and 10.2 mm differences at 6, 12, 18, and 26 wks; overall difference p = 0.032). No significant between-group differences in SF-36, Charnley hip pain score, ability to walk or walking aids during follow-up. No patient was radiographically healed at 6 wks, and 90% were healed at 12 wks in both groups. Implant failure (TPTD:7, RIS:8), loss of reduction (TPTD:2, RIS:4) or non-union (0 cases) showed no significant differences. Mild hypercalcemia and hyperuricemia were more frequent with teriparatide. Conclusions: Patients treated with teriparatide reported less hip pain and shorter time to complete the TUG test than RIS between 6-26 wks. These outcomes were secondary

Predictors of long-term pain after hip arthroplasty in patients with femoral neck fractures: a cohort study

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.Orthopaedics, Trauma Surgery and Rehabilitatio

What factors increase revision surgery risk when treating displaced femoral neck fractures with arthroplasty: a secondary analysis of the HEALTH trial

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.Orthopaedics, Trauma Surgery and Rehabilitatio

What predicts health-related quality of life for patients with displaced femoral neck fractures managed with arthroplasty?: A secondary analysis of the HEALTH trial

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.Orthopaedics, Trauma Surgery and Rehabilitatio

Different competing risks models applied to data from the Australian Orthopaedic Association National Joint Replacement Registry

Purpose: Here we describe some available statistical models and illustrate their use for analysis of arthroplasty registry data in the presence of the competing risk of death, when the influence of covariates on the revision rate may be different to the influence on the probability (that is, risk) of the occurrence of revision. Patients and methods: Records of 12,525 patients aged 75–84 years who had received hemiarthroplasty for fractured neck of femur were obtained from the Australian Orthopaedic Association National Joint Replacement Registry. The covariates whose effects we investigated were: age, sex, type of prosthesis, and type of fixation (cementless or cemented). Extensions of competing risk regression models were implemented, allowing the effects of some covariates to vary with time. Results: The revision rate was significantly higher for patients with unipolar than bipolar prostheses (HR = 1.38, 95% CI: 1.01–1.89) or with monoblock than bipolar prostheses (HR = 1.45, 95% CI: 1.08–1.94). It was significantly higher for the younger age group (75–79 years) than for the older one (80–84 years) (HR = 1.28, 95% CI: 1.05–1.56) and higher for males than for females (HR = 1.37, 95% CI: 1.09–1.71). The probability of revision, after correction for the competing risk of death, was only significantly higher for unipolar prostheses than for bipolar prostheses, and higher for the younger age group. The effect of fixation type varied with time; initially, there was a higher probability of revision for cementless prostheses than for cemented prostheses, which disappeared after approximately 1.5 years. Interpretation: When accounting for the competing risk of death, the covariates type of prosthesis and sex influenced the rate of revision differently to the probability of revision. We advocate the use of appropriate analysis tools in the presence of competing risks and when covariates have time-dependent effects.Marianne H Gillam, Amy Salter, Philip Ryan, and Stephen E Grave

Predictors of Medical Serious Adverse Events in Hip Fracture Patients Treated With Arthroplasty

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

The FAITH and HEALTH Trials: Are We Studying Different Hip Fracture Patient Populations?

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

Factors Associated With Mortality After Surgical Management of Femoral Neck Fractures

BACKGROUND: Hip fractures are recognized as one of the most devastating injuries impacting older adults because of the complications that follow. Mortality rates postsurgery can range from 14% to 58% within one year of fracture. We aimed to identify factors associated with increased risk of mortality within 24 months of a femoral neck fracture in patients aged ≥50 years enrolled in the FAITH and HEALTH trials. METHODS: Two multivariable Cox proportional hazards regressions were used to investigate potential prognostic factors that may be associated with mortality within 90 days and 24 months of hip fracture. RESULTS: Ninety-one (4.1%) and 304 (13.5%) of 2247 participants died within 90 days and 24 months of suffering a femoral neck fracture, respectively. Older age (P < 0.001), lower body mass index (P = 0.002), American Society of Anesthesiologists (ASA) class III/IV/V (P = 0.004), use of an ambulatory aid before femoral neck fracture (P < 0.001), and kidney disease (P < 0.001) were associated with a higher risk of mortality within 24 months of femoral neck fracture. Older age (P = 0.03), lower body mass index (P = 0.02), use of an ambulatory aid before femoral neck fracture (P < 0.001), and having a comorbidity (P = 0.04) were associated with a higher risk of mortality within 90 days of femoral neck fracture. CONCLUSIONS: Our analysis found that factors that are indicative of a poorer health status were associated with a higher risk of mortality within 24 months of femoral neck fracture. We did not find a difference in treatment methods (internal fixation vs. joint arthroplasty) on the risk of mortality. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence