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Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_16 | Pages 85 - 85
19 Aug 2024
Schemitsch E Nowak L Shehata M Sprague S Bzovsky S Bhandari M
Full Access

We aimed to examine outcomes between displaced femoral neck fracture (FNF) patients managed with total hip arthroplasty (THA) or hemi-arthroplasty (HA) via the anterolateral vs. posterior approach.

We used data from the HEALTH trial (1,441 patients aged ≥50 with displaced FNFs randomized to THA vs. HA). We calculated each patient's propensity to undergo arthroplasty via the posterior approach, and matched them to 1 control (anterolateral approach) based on age (±5 years), and propensity score. We used Chi-Square/Fisher-Exact tests to compare dichotomous outcomes, and repeated measures ANOVA to examine differences in patient-reported outcomes (via the WOMAC subscores) from baseline to one-year postoperative. We used logistic regression to identify independent predictors of reoperation for instability in the posterior group.

We identified 1,306 patients for this sub-analysis, 876 (67.1%) who received arthroplasty via an anterolateral approach, and 430 (32.9%) a posterior approach. The unadjusted rate of reoperation was significantly higher in the posterior group (10.7% vs. 7.1%).

Following propensity score matching, we retained 790 patients (395 per group), with no between-group differences in patient, fracture, or implant characteristics. The matched cohort had a higher rate of comorbidities, and were less likely to be employed vs. the unmatched cohort. The rate of treatment for dislocation remained higher in the posterior group (6.1% vs. 2.0%) following matching.

Repeated measures ANOVA revealed significantly better WOMAC pain, stiffness, function, and total scores in the posterior group. Between-group differences at 12-months were: pain - 0.59 (0.03–1.15); stiffness - 0.62 (0.35–0.87); function - 2.99 (0.12–5.86); total - 3.90 (0.24–7.56). We identified THA (vs. HA, odds ratio 2.05 [1.05–4.01]) as the only independent predictor of treatment for dislocation in the posterior group.

Our analyses revealed that compromised patients with displaced FNFs who undergo arthroplasty via the posterior approach may report better symptoms at one-year vs. the anterolateral approach, despite a higher odds of reoperation for instability.


Bone & Joint Open
Vol. 4, Issue 5 | Pages 370 - 377
19 May 2023
Comeau-Gauthier M Bzovsky S Axelrod D Poolman RW Frihagen F Bhandari M Schemitsch E Sprague S

Aims

Using data from the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemiarthroplasty (HEALTH) trial, we sought to determine if a difference in functional outcomes exists between monopolar and bipolar hemiarthroplasty (HA).

Methods

This 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.


Bone & Joint Open
Vol. 4, Issue 3 | Pages 168 - 181
14 Mar 2023
Dijkstra H Oosterhoff JHF van de Kuit A IJpma FFA Schwab JH Poolman RW Sprague S Bzovsky S Bhandari M Swiontkowski M Schemitsch EH Doornberg JN Hendrickx LAM

Aims

To develop prediction models using machine-learning (ML) algorithms for 90-day and one-year 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 one-year 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).


Bone & Joint Open
Vol. 3, Issue 8 | Pages 611 - 617
1 Aug 2022
Frihagen F Comeau-Gauthier M Axelrod D Bzovsky S Poolman R Heels-Ansdell D Bhandari M Sprague S Schemitsch E

Aims

The aim of this study was to explore the functional results in a fitter subgroup of participants in the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemiarthroplasty (HEALTH) trial to determine whether there was an advantage of total hip arthroplasty (THA) versus hemiarthroplasty (HA) in this population.

Methods

We performed a post hoc exploratory analysis of a fitter cohort of patients from the HEALTH trial. Participants were aged over 50 years and had sustained a low-energy displaced femoral neck fracture (FNF). The fittest participant cohort was defined as participants aged 70 years or younger, classified as American Society of Anesthesiologists grade I or II, independent walkers prior to fracture, and living at home prior to fracture. Multilevel models were used to estimate the effect of THA versus HA on functional outcomes. In addition, a sensitivity analysis of the definition of the fittest participant cohort was performed.


Bone & Joint Research
Vol. 11, Issue 4 | Pages 239 - 250
20 Apr 2022
Stewart CC O’Hara NN Bzovsky S Bahney CS Sprague S Slobogean GP

Aims

Bone turnover markers (BTMs) follow distinct trends after fractures and limited evidence suggests differential levels in BTMs in patients with delayed healing. The effect of vitamin D, and other factors that influence BTMs and fracture healing, is important to elucidate the use of BTMs as surrogates of fracture healing. We sought to determine whether BTMs can be used as early markers of delayed fracture healing, and the effect of vitamin D on BTM response after fracture.

Methods

A total of 102 participants aged 18 to 50 years (median 28 years (interquartile range 23 to 35)), receiving an intramedullary nail for a tibial or femoral shaft fracture, were enrolled in a randomized controlled trial comparing vitamin D3 supplementation to placebo. Serum C-terminal telopeptide of type I collagen (CTX; bone resorption marker) and N-terminal propeptide of type I procollagen (P1NP; bone formation marker) were measured at baseline, six weeks, and 12 weeks post-injury. Clinical and radiological fracture healing was assessed at three months.


Bone & Joint Open
Vol. 3, Issue 4 | Pages 284 - 290
1 Apr 2022
O'Hara NN Carullo J Joshi M Banoub M Claeys KC Sprague S Slobogean GP O'Toole RV

Aims

There is increasing evidence to support the use of topical antibiotics to prevent surgical site infections. Although previous research suggests a minimal nephrotoxic risk with a single dose of vancomycin powder, fracture patients often require multiple procedures and receive additional doses of topical antibiotics. We aimed to determine if cumulative doses of intrawound vancomycin or tobramycin powder for infection prophylaxis increased the risk of drug-induced acute kidney injury (AKI) among fracture patients.

Methods

This cohort study was a secondary analysis of single-centre Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma (PREP-IT) trial data. We included patients with a surgically treated appendicular fracture. The primary outcome was drug-induced AKI. The odds of AKI per gram of vancomycin or tobramycin powder were calculated using Bayesian regression models, which adjusted for measured confounders and accounted for the interactive effects of vancomycin and tobramycin.


Bone & Joint Open
Vol. 3, Issue 3 | Pages 189 - 195
4 Mar 2022
Atwan Y Sprague S Slobogean GP Bzovsky S Jeray KJ Petrisor B Bhandari M Schemitsch E

Aims

To evaluate the impact of negative pressure wound therapy (NPWT) on the odds of having deep infections and health-related quality of life (HRQoL) following open fractures.

Methods

Patients from the Fluid Lavage in Open Fracture Wounds (FLOW) trial with Gustilo-Anderson grade II or III open fractures within the lower limb were included in this secondary analysis. Using mixed effects logistic regression, we assessed the impact of NPWT on deep wound infection requiring surgical intervention within 12 months post-injury. Using multilevel model analyses, we evaluated the impact of NPWT on the Physical Component Summary (PCS) of the 12-Item Short-Form Health Survey (SF-12) at 12 months post-injury.


The Bone & Joint Journal
Vol. 103-B, Issue 6 | Pages 1055 - 1062
1 Jun 2021
Johal H Axelrod D Sprague S Petrisor B Jeray KJ Heels-Ansdell D Bzovsky S Bhandari M

Aims

Despite long-standing dogma, a clear relationship between the timing of surgical irrigation and debridement (I&D) and the development of subsequent deep infection has not been established in the literature. Traditionally, I&D of an open fracture has been recommended within six hours of injury based on animal studies from the 1970s, however the clinical basis for this remains unclear. Using data from a multicentre randomized controlled trial of 2,447 open fracture patients, the primary objective of this secondary analysis is to determine if a relationship exists between timing of wound I&D (within six hours of injury vs beyond six hours) and subsequent reoperation rate for infection or healing complications within one year for patients with open limb fractures requiring surgical treatment.

Methods

To adjust for the influence of patient and injury characteristics on the timing of I&D, a propensity score was developed from the dataset. Propensity-adjusted regression allowed for a matched cohort analysis within the study population to determine if early irrigation put patients independently at risk for reoperation, while controlling for confounding factors. Results were reported as odds ratios (ORs), 95% confidence intervals (CIs), and p-values. All analyses were conducted using STATA 14.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_3 | Pages 55 - 55
1 Mar 2021
Prada C Bzovsky S Tanner S Marcano-Fernandez F Jeray K Schemitsch E Bhandari M Petrisor B Sprague S
Full Access

Many studies report the incidence and prevalence of surgical site infections (SSIs) following open fractures; however, there is limited information on the treatment and subsequent outcomes of superficial SSIs in open fracture patients. There is also a lack of clinical studies describing the prognostic factors that are associated with failure of antibiotic treatment (non-operative) for superficial SSI. To address this gap, we used data from the FLOW (Fluid Lavage in Open Fracture Wounds) trial to determine how successful antibiotic treatment was for superficial SSIs and to identify prognostic factors that could be predictive of antibiotic treatment failure.

This is a secondary analysis of the FLOW trial dataset. The FLOW trial included 2,445 operatively managed open fracture patients. FLOW participants who had a non-operatively managed superficial SSI diagnosed in the 12 months post-fracture were included in this analysis. Participants were grouped into two categories: 1) participants whose superficial SSI resolved with antibiotics alone and 2) participants whose SSI did not resolve with antibiotics alone (defined as requiring surgical management or SSI being unresolved at final follow-up (12-months post-fracture for the FLOW trial)). Antibiotic treatment success and the date when this occurred was defined by the treating surgeon. A logistic binary regression analysis was conducted to identify factors associated with superficial SSI antibiotic success. Based on biologic rationale and previous literature, a priori we identified 13 (corresponding to 14 levels) potential factors to be included in the regression model.

Superficial SSIs were diagnosed in168 participants within 12 months of their fracture. Of these, 139 (82.7%) had their superficial SSI treated with antibiotics alone. The antibiotic treatment was successful in resolving the superficial SSI in 97 participants (69.8%) and unsuccessful in resolving the SSI in 42 participants (30.2%). We found that superficial SSIs that were diagnosed later in follow-up were associated with failure of treatment with antibiotic alone (Odds ratio 1.05 for every week in diagnosis delay, 95% Confidence Interval 1.004–1.099; p=0.03). Age, sex, fracture severity, fracture pattern, wound size, time from injury to initial surgical irrigation and debridement were not associated with antibiotic treatment failure.

Our secondary analysis of prospectively collected FLOW data found antibiotics alone resolved superficial SSIs in 69.8% of patients diagnosed with superficial SSIs. We also found that superficial SSIs that were diagnosed earlier in follow-up were associated with successful treatment with antibiotics alone. This suggests that if superficial SSIs are diagnosed and treated promptly, there is a higher probability that they will resolve with antibiotic treatment.


Bone & Joint Open
Vol. 2, Issue 1 | Pages 22 - 32
4 Jan 2021
Sprague S Heels-Ansdell D Bzovsky S Zdero R Bhandari M Swiontkowski M Tornetta P Sanders D Schemitsch E

Aims

Using tibial shaft fracture participants from a large, multicentre randomized controlled trial, we investigated if patient and surgical factors were associated with health-related quality of life (HRQoL) at one year post-surgery.

Methods

The Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) trial examined adults with an open or closed tibial shaft fracture who were treated with either reamed or unreamed intramedullary nails. HRQoL was assessed at hospital discharge (for pre-injury level) and at 12 months post-fracture using the Short Musculoskeletal Functional Assessment (SMFA) Dysfunction, SMFA Bother, 36-Item Short Form 36 (SF-36) Physical, and SF-36 Mental Component scores. We used multiple linear regression analysis to determine if baseline and surgical factors, as well as post-intervention procedures within one year of fracture, were associated with these HRQoL outcomes. Significance was set at p < 0.01. We hypothesize that, irrespective of the four measures used, prognosis is guided by both modifiable and non-modifiable factors and that patients do not return to their pre-injury level of function, nor HRQoL.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_8 | Pages 68 - 68
1 Aug 2020
Atwan Y Sprague S Bzovsky S Jeray K Petrisor B Bhandari M Schemitsch EH
Full Access

Negative pressure wound therapy (NPWT) is commonly used to manage severe open fracture wounds. The recently completed X randomized controlled trial (RCT) evaluated the effect of NPWT versus standard wound management on 12-month disability and rate of deep infection among patients with severe open fractures of the lower limb and reported no differences. Using data from the Y trial of open fracture patients, we aimed to evaluate the impact of NPWT on the odds of having deep infections and health-related quality of life (HRQL).

Our analyses included participants from the Y trial who had Gustilo II and III lower extremity fractures. To adjust for the influence of injury characteristics on type of dressing received, a propensity score was developed from the dataset. A one-to-one matching algorithm was then used to pair patients with a similar propensity for NPWT.

Mixed effects logistic regression was used to evaluate the association between type of wound dressing and development of a deep infection requiring operative management (dependent variable) in the matched cohort. Gustilo type, irrigation solution, fracture location, mechanism of injury, and degree of contamination were included as adjustment variables. To determine any differences in HRQL between the NPWT and standard wound dressing groups, we conducted two multi-level models with three levels (centre, patient, and time) and included Short Form-12 (SF-12) Physical Health Component (PCS) and SF-12 Mental Health Component (MCS) as dependent variables. Gustilo type, irrigation solution, fracture location, mechanism of injury, degree of contamination, and pre-injury SF-12 scores were included as adjustment variables. All tests were 2-tailed with alpha=0.05.

After applying propensity score-matching to adjust for the influence of injury characteristics on type of dressing used, there were 270 matched pairs of patients available for comparison. The odds of developing a deep infection requiring operative management within 12 months of initial surgery was 4.22 times higher in patients who received NPWT compared to those who did not receive NPWT (Odds Ratio (OR) 4.22, 95% Confidence Interval (CI) 2.26–7.87.

1,329 participants were included in our HRQL analysis and those treated with NPWT had significantly lower SF-12 PCS at all follow-up visits (6w, 3m, 6m, 12m) post fracture (p=0.01). Participants treated with NPWT had significantly lower SF-12 MCS at 6-weeks post-fracture (p=0.03).

Unlike the X trial, our analysis found that patients treated with NPWT had higher odds of developing a deep infection requiring operative management and that being treated with NPWT was associated with lower physical quality of life in the 12 months post-fracture. While there may have been other potential adjustment variables not controlled for in this analysis, our results suggest that the use of this treatment should be re-evaluated.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_8 | Pages 30 - 30
1 Aug 2020
Ristevski B Gjorgjievski M Petrisor B Williams D Denkers M Rajaratnam K Johal H Al-Asiri J Chaudhry H Nauth A Hall J Whelan DB Ward S Atrey A Khoshbin A Leighton R Duffy P Schneider P Korley R Martin R Beals L Elgie C Ginsberg L Mehdian Y McKay P Simunovic N Ratcliffe J Sprague S Vicente M Scott T Hidy J Suthar P Harrison T Dillabough K Yee S Garibaldi A Bhandari M
Full Access

Distracted driving is now the number one cause of death among teenagers in the United States of America according to the National Highway Traffic Safety Administration. However, the risks and consequences of driving while distracted spans all ages, gender, and ethnicity. The Distractions on the Road: Injury eValuation in Surgery And FracturE Clinics (DRIVSAFE) Study aimed to examine the prevalence of distracted driving among patients attending hospital-based orthopaedic surgery fracture clinics. We further aimed to explore factors associated with distracted driving.

In a large, multi-center prospective observational study, we recruited 1378 adult patients with injuries treated across four clinics (Hamilton, Ontario, Toronto, Ontario, Calgary, Alberta, Halifax, Nova Scotia) across Canada. Eligible patients included those who held a valid driver's license and were able to communicate and understand written english. Patients were administered questions about distracted driving. Data were analyzed with descriptive statistics.

Patients average age was 45.8 years old (range 16 – 87), 54.3% male, and 44.6% female (1.1% not disclosed). Of 1361 patients, 1358 self-reported distracted driving (99.8%). Common sources of distractions included talking to passengers (98.7%), outer-vehicle distractions (95.5%), eating/drinking (90.4%), music listening/adjusting the radio (97.6%/93.8%), singing (83.2%), accepting phone calls (65.6%) and daydreaming (61.2%). Seventy-nine patients (6.3%), reported having been stopped by police for using a handheld device in the past. Among 113 drivers who disclosed the cause of their injury as a motor vehicle crash (MVC), 20 of them (17%) acknowledged being distracted at the time of the crash. Of the participants surveyed, 729 reported that during their lifetime they had been the driver in a MVC, with 226 (31.1%) acknowledging they were distracted at the time of the crash.

Approximately, 1 in 6 participants in this study had a MVC where they reported to be distracted. Despite the overwhelming knowledge that distracted driving is dangerous and the recognition by participants that it can be dangerous, a staggering amount of drivers engage in distracted driving on a fairly routine basis. This study demonstrates an ongoing need for research and driver education to reduce distracted driving and its devastating consequences.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_6 | Pages 145 - 145
1 Jul 2020
Sprague S Okike K Slobogean G Swiontkowski Bhandari M Udogwu UN Isaac M
Full Access

Internal fixation is currently the standard of care for Garden I and II femoral neck fractures in the elderly. However, there may be a degree of posterior tilt on the preoperative lateral radiograph above which failure is likely, and primary arthroplasty would be preferred. The purpose of this study was to determine the association between posterior tilt and the risk of subsequent arthroplasty following internal fixation of Garden I and II femoral neck fractures in the elderly.

This study represents a secondary analysis of data collected in the FAITH trial, an international multicenter randomized controlled trial comparing the sliding hip screw to cannulated screws in the management of femoral neck fractures in patients aged 50 years or older. For each patient who sustained a Garden I or II femoral neck fracture and had an adequate preoperative lateral radiograph, the amount of posterior tilt was categorized as < 2 0 degrees or ≥20 degrees. Multivariable Cox proportional hazards analysis was used to assess the association between posterior tilt and subsequent arthroplasty during the two-year follow-up period, while controlling for potential confounders.

Of the 555 patients in the study sample, posterior tilt was classified as ≥20 degrees for 67 (12.1%) and < 2 0 degrees for 488 (87.9%). Overall, 13.2% (73/555) of patients underwent subsequent arthroplasty in the 24-month follow-up period. In the multivariable analysis, patients with posterior tilt ≥20 degrees had a significantly increased risk of subsequent arthroplasty compared to those with posterior tilt < 2 0 degrees (22.4% (15/67) vs 11.9% (58/488), Hazard Ratio (HR) 2.22, 95% confidence interval (CI) 1.24–4, p=0.008). The other factor associated with subsequent arthroplasty was age ≥80 (p=0.03).

In this study of patients with Garden I and II femoral neck fractures, posterior tilt ≥20 degrees was associated with a significantly increased risk of subsequent arthroplasty. Primary arthroplasty should be considered for Garden I and II femoral neck fractures with posterior tilt ≥20 degrees, especially among older patients.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_6 | Pages 134 - 134
1 Jul 2020
Bzovsky S Johal H Axelrod D Sprague S Petrisor B Jeray K Heels-Ansdell D Bhandari M
Full Access

Despite long-standing dogma, a clear relationship between the timing of surgical irrigation and the development of subsequent deep infection has not been established in the literature. Traditionally, irrigation of an open fracture has been recommended within six-hours of injury based on animal studies from the 1970s, however the clinical basis for this remains unclear. Using data from a multi-centre randomized controlled trial of 2,447 open fracture patients, the primary objective of this secondary analysis is to determine if a relationship exists between timing of wound irrigation (within six hours of injury versus beyond six hours) and subsequent reoperation rate for infection or healing complications within one year for patients with open extremity fractures requiring surgical treatment.

To adjust for the influence of patient and injury characteristics on the timing of irrigation, a propensity score was developed from the data set. Propensity-adjusted regression allowed for a matched cohort analysis within the study population to determine if early irrigation put patients independently at risk for reoperation, while controlling for confounding factors. Results were reported as odds ratios (ORs), 95% Confidence Intervals (CIs), and p-values. All analyses were conducted using STATA 14 (StataCorp LP, College Station, TX, USA).

Two thousand, two hundred eighty-six of 2,447 patients randomized to the trial from 41 orthopaedic trauma centers across five countries had complete data regarding time to irrigation. Prior to matching, the patients managed with early irrigation had a higher proportion requiring reoperation for infection or healing complications (17% versus 12.8%, p=0.02), however this does not account for selection bias of more severe injuries preferentially being treated earlier. After the propensity score-matching algorithm was applied, there were 373 matched pairs of patients available for comparison. In the matched cohort, reoperation rates did not differ between early and late groups (16.1% vs 16.6%, p=0.84). When accounting for propensity matching in a logistic regression analysis, early irrigation was not associated with reoperation (OR 0.93, 95% CI 0.62 to 1.40, p=0.73).

When accounting for other variables, late irrigation does not independently increase risk of reoperation.


The Bone & Joint Journal
Vol. 100-B, Issue 10 | Pages 1270 - 1274
1 Oct 2018
Manta A Opingari E Saleh A Simunovic N Duong A Sprague S Peterson D Bhandari M

Aims

The aims of this systematic review were to describe the quantity and methodological quality of meta-analyses in orthopaedic surgery published during the last 17 years.

Materials and Methods

MEDLINE, EMBASE, and PubMed, between 1 January 2000 and 31 December 2016, were searched for meta-analyses in orthopaedic surgery dealing with at least one surgical intervention. Meta-analyses were included if the interventions involved a human muscle, ligament, bone or joint.


The Bone & Joint Journal
Vol. 100-B, Issue 9 | Pages 1227 - 1233
1 Sep 2018
Gitajn IL Titus AJ Tosteson AN Sprague S Jeray K Petrisor B Swiontkowski M Bhandari M Slobogean G

Aims

The aims of this study were to quantify health state utility values (HSUVs) after a tibial fracture, investigate the effect of complications, to determine the trajectory in HSUVs that result in these differences and to quantify the quality-adjusted life years (QALYs) experienced by patients.

Patients and Methods

This is an analysis of 2138 tibial fractures enrolled in the Fluid Lavage of Open Wounds (FLOW) and Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) trials. Patients returned for follow-up at two and six weeks and three, six, nine and 12 months. Short-Form Six-Dimension (SF-6D) values were calculated and used to calculate QALYs.


The Bone & Joint Journal
Vol. 100-B, Issue 3 | Pages 361 - 369
1 Mar 2018
Sprague S Bhandari M Heetveld MJ Liew S Scott T Bzovsky S Heels-Ansdell D Zhou Q Swiontkowski M Schemitsch EH

Aims

The primary aim of this prognostic study was to identify baseline factors associated with physical health-related quality of life (HRQL) in patients after a femoral neck fracture. The secondary aims were to identify baseline factors associated with mental HRQL, hip function, and health utility.

Patients and Methods

Patients who were enrolled in the Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH) trial completed the 12-item Short Form Health Survey (SF-12), Western Ontario and McMaster Universities Arthritis Index, and EuroQol 5-Dimension at regular intervals for 24 months. We conducted multilevel mixed models to identify factors potentially associated with HRQL.


The Bone & Joint Journal
Vol. 100-B, Issue 1 | Pages 88 - 94
1 Jan 2018
Sprague S Petrisor B Jeray K McKay P Heels-Ansdell D Schemitsch E Liew S Guyatt G Walter SD Bhandari M

Aims

The Fluid Lavage in Open Fracture Wounds (FLOW) trial was a multicentre, blinded, randomized controlled trial that used a 2 × 3 factorial design to evaluate the effect of irrigation solution (soap versus normal saline) and irrigation pressure (very low versus low versus high) on health-related quality of life (HRQL) in patients with open fractures. In this study, we used this dataset to ascertain whether these factors affect whether HRQL returns to pre-injury levels at 12-months post-injury.

Patients and Methods

Participants completed the Short Form-12 (SF-12) and the EuroQol-5 Dimensions (EQ-5D) at baseline (pre-injury recall), at two and six weeks, and at three, six, nine and 12-months post-fracture. We calculated the Physical Component Score (PCS) and the Mental Component Score (MCS) of the SF-12 and the EQ-5D utility score, conducted an analysis using a multi-level generalized linear model, and compared differences between the baseline and 12-month scores.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_21 | Pages 8 - 8
1 Dec 2016
Slobogean G Osterhoff G O'Hara N D'Cruz J Sprague S Bansback N Evaniew N
Full Access

There is ongoing debate regarding the optimal surgical treatment of complex proximal humeral fractures in elderly patients. The aim of this study was to evaluate the cost-effectiveness of reverse total shoulder arthroplasty (RTSA) compared to hemiarthroplasty (HA) in the management of these fractures.

A cost–utility analysis using decision tree and Markov modelling based on data from the published literature was conducted. A single-payer perspective with a lifetime time horizon was adopted. A willingness to pay threshold of CAD $50,000 was used. The incremental cost-effectiveness ratio (ICER) was used as the study's primary outcome measure.

In comparison to HA, the incremental cost per QALY gained for RTSA was $13,679. One-way sensitivity analysis revealed the model to be sensitive to the RTSA implant cost and the RTSA procedural costs. Two-way sensitivity analysis suggested RTSA could also be cost-effective within the first two years of surgery with an early complication rate as high as 25% (if RTSA implant cost was approximately $3,000); or conversely, RTSA implant cost could be as high as $8,500 if its early complication rates were 5%. The ICER of $13,679 is well below the WTP threshold of $50,000 and probabilistic sensitivity analysis demonstrated that 92.6% of model simulations favoured RTSA.

Our economic analysis found that RTSA for the treatment of complex proximal humeral fractures in the elderly is the preferred economic strategy when compared to HA. The ICER of RTSA is well-below standard willingness to pay thresholds, and its estimate of cost-effectiveness is similar to other highly successful orthopaedic strategies such as total hip arthroplasty for the treatment of hip arthritis.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_21 | Pages 80 - 80
1 Dec 2016
Frank T Osterhoff G Sprague S Hak A Bhandari M Slobogean G
Full Access

The Radiographic Union Score for Hip (RUSH) is an outcome instrument designed to describe radiographic healing of femoral neck fractures. The ability to identify fractures that have not healed is important for defining non-union in clinical trials and predicting patients that likely require additional surgery to promote fracture healing. We sought to determine a RUSH threshold score that defines nonunion at 6-months post-injury. Our secondary objective was to determine if this threshold was associated with increased risk for non-union surgery.

A sample of 248 patients with adequate six-month hip radiographs and complete two-year clinical follow-up were analysed from a multi-national hip fracture trial (FAITH). All patients had a femoral neck fracture and were treated with either multiple cancellous screws or a sliding hip screw. Two reviewers independently determined the RUSH score based on the six-month post-injury radiographs, and agreement was assessed using the Interclass Correlation Coefficient (ICC). Fracture healing was determined by two independent methods: 1) prospectively by the treating surgeon using clinical and radiographic assessments, and 2) retrospectively by a Central Adjudication Committee using radiographs alone. Receiver Operator Curve analysis was used to define a RUSH threshold score that was specific for fracture nonunion.

RUSH score inter-rater agreement was high (ICC: 0.81, 95% CI 0.76 to 0.85). The mean six-month RUSH score for all included patients was 24.4 (SD 3.4). A threshold score of <18 was associated with a greater than 98% specificity for nonunion. Furthermore, patients with a six-month RUSH score below 18 were more the seven-times more likely to require revision surgery for nonunion (Relative Risk: 7.25, 95% CI 2.62 to 20.00).

The six-month RUSH score can effectively be used to communicate when a femoral neck fracture has not healed. The validity of our conclusions was further supported by the increased risk of nonunion surgery for patients below the RUSH threshold. We believe our findings can standardise a definition of nonunion for clinical trials and recommend the use of the RUSH and its <18-point threshold when describing femoral neck nonunion.