Functional outcomes are important for patients with bone tumors undergoing lower extremity endoprosthetic reconstruction; however, there is limited empirical evidence evaluating function longitudinally. The objective of this study was to determine the changes in function over time in patients undergoing endoprosthetic reconstructions of the proximal femur, distal femur and proximal tibia.

We conducted a secondary analysis of functional outcome data from the Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) trial. Patient function was assessed with the Musculoskeletal Tumor Society Score 93 (MSTS) and the Toronto Extremity Salvage Score (TESS), which were administered preoperatively and at 3, 6 and 12 months postoperatively. Both instruments are scored from 0-100, with higher scores indicated greater function. Mean functional scores were evaluated over time and we explored for differences among patients undergoing proximal femur reconstructions (PFR), distal femur reconstructions (DFR) and proximal tibia reconstructions (PTR). The patient-importance of statistically significant differences in function was evaluated utilizing the minimally important difference (MID) of 12 for the MSTS and 11 for the TESS. We explored for differences in change scores between each time interval with paired t-tests. Differences based on endoprosthetic reconstruction undertaken were evaluated by analysis of variance and post-hoc comparisons using the Tukey test.

A total of 573 patients were included. The overall mean MSTS and TESS scores were 77.1(SD±21) and 80.2(SD±20) respectively at 1-year post-surgery, demonstrating approximately a 20-point improvement from baseline for both instruments. When evaluating change scores over time by type of reconstruction, PFR patients experienced significant functional improvement during the 3-6 and 6-12 month follow-up intervals, DFR patients demonstrated significant improvements in function at each follow-up interval, and PTR patients reported a significant decrease in function from baseline to 3 months, and subsequent improvements during the 3-6 and 6-12 month intervals.

On average, patients undergoing endoprosthetic reconstruction of the lower extremity experience important improvements in function from baseline within the first year. Patterns of functional recovery varied significantly based on type of reconstruction performed. The results of this study will inform both clinicians and patients about the expected rehabilitation course and functional outcomes following endoprosthetic reconstruction of the lower extremity.

The presence of metastatic bone disease (MBD) often necessitates major orthopaedic surgery. Patients will enter surgical care either through emergent or electively scheduled care pathways. Patients in a pain crisis or with an acute fracture are generally admitted via emergent care pathways whereas patients with identified high-risk bone lesions are often booked for urgent yet scheduled elective procedures. The purpose of this study is to compare the post-operative outcomes of patients who present through emergent or electively scheduled care pathways in patients in a Canadian health care system.

We have conducted a retrospective, multicenter cohort study of all patients presenting for surgery for MBD of the femur, humerus, tibia or pelvis in southern Alberta between 2006 and 2021. Patients were identified by a search query of all patients with a diagnosis of metastatic cancer who underwent surgery for an impending or actual pathologic fracture in the Calgary, South and Central Alberta Zones. Subsequent chart reviews were performed. Emergent surgeries were defined by patients admitted to hospital via urgent care mechanisms and managed via unscheduled surgical bookings (“on call list”). Elective surgeries were defined by patients seen by an orthopaedic surgeon at least once prior to surgery, and booked for a scheduled urgent, yet elective procedure. Outcomes include overall survival from the time of surgery, hospital length of stay, and 30-day hospital readmission rate.

We have identified 402 patients to date for inclusion. 273 patients (67.9%) underwent surgery through emergent pathways and 129 patients (32.1%) were treated through urgent, electively scheduled pathways. Lung, prostate, renal cell, and breast cancer were the most common primary malignancies and there was no significant difference in these primaries amongst the groups (p=0.06). Not surprisingly, emergent patients were more likely to be treated for a pathologic fracture (p<0.001) whereas elective patients were more likely to be treated for an impending fracture (p<0.001). Overall survival was significantly shorter in the emergent group (5.0 months, 95%CI: 4.0-6.1) compared to the elective group (14.9 months 95%CI: 10.4-24.6) [p<0.001]. Hospital length of stay was significantly longer in the emergent group (13 days, 95%CI: 12-16 versus 5 days, 95%CI: 5-7 days). There was a significantly greater rate of 30-day hospital readmission in the emergent group (13.3% versus 7.8%) [p=0.01].

Electively managed MBD has multiple benefits including longer post-operative survival, shorter length of hospital stay, and a lower rate of 30-day hospital readmission. These findings from a Canadian healthcare system demonstrate clinical value in providing elective orthopaedic care when possible for patients with MBD. Furthermore, care delivery interventions capable of decreasing the footprint of emergent surgery through enhanced screening or follow-up of patients with MBD has the potential to significantly improve clinical outcomes in this population. This is an ongoing study that will justify refinements to the current surgical care pathways for MBD in order to identify patients prior to emergent presentation. Future directions will evaluate the costs associated with each care delivery method to provide opportunity for health economic efficiencies.

The widely used Fracture Risk Assessment Tool (FRAX) estimates a 10-year probability of major osteoporotic fracture (MOF) using age, sex, body mass index, and seven clinical risk factors, including prior history of fracture. Prior fracture is a binary variable in FRAX, although it is now clear that prior fractures affect future MOF risk differently depending on their recency and site. Risk of MOF is highest in the first two years following a fracture and then progressively decreases with time – this is defined as imminent risk. Therefore, the FRAX tool may underestimate true fracture risk and result in missed opportunities for earlier osteoporosis management in individuals with recent MOF. To address this, multipliers based on age, sex, and fracture type may be applied to baseline FRAX scores for patients with recent fractures, producing a more accurate prediction of both short- and long-term fracture risk. Adjusted FRAX estimates may enable earlier pharmacologic treatment and other risk reduction strategies. This study aimed to report the effect of multipliers on conventional FRAX scores in a clinical cohort of patients with recent non-hip fragility fractures.

After obtaining Research Ethics Board approval, FRAX scores were calculated both before and after multiplier adjustment, for patients included in our outpatient Fracture Liaison Service who had experienced a non-hip fragility fracture between June 2020 and November 2021. Patients age 50 years or older, with recent (within 3 months) forearm (radius and/or ulna) or humerus fractures were included. Exclusion criteria consisted of patients under the age of 50 years or those with a hip fracture. Age- and sex-based FRAX multipliers for recent forearm and humerus fractures described by McCloskey et al. (2021) were used to adjust the conventional FRAX score. Low, intermediate and high-risk of MOF was defined as less than 10%, 10-20%, and greater than 20%, respectively. Data are reported as mean and standard deviation of the mean for continuous variables and as proportions for categorical variables.

A total of 91 patients with an average age of 64 years (range = 50-97) were included. The majority of patients were female (91.0%), with 73.6% sustaining forearm fractures and 26.4% sustaining humerus fractures. In the forearm group, the average MOF risk pre- and post-multiplier was 16.0 and 18.8, respectively. Sixteen percent of patients (n = 11) in the forearm group moved from intermediate to high 10-year fracture risk after multiplier adjustment. Average FRAX scores before and after adjustment in the humerus group were 15.7 and 22.7, respectively, with 25% (n = 6) of patients moving from an intermediate risk to a high-risk score.

This study demonstrates the clinically significant impact of multipliers on conventional FRAX scores in patients with recent non-hip fractures. Twenty-five percent of patients with humerus fractures and 16% of patients with forearm fractures moved from intermediate to high-risk of MOF after application of the multiplier. Consequently, patients who were previously ineligible for pharmacologic management, now met criteria. Multiplier-adjusted FRAX scores after a recent fracture may more accurately identify patients with imminent fracture risk, facilitating earlier risk reduction interventions.

Thrombelastography (TEG) is a point-of-care tool that can measure clot formation and breakdown using a whole blood sample. We have previously used serial TEG analysis to define hypercoagulability and increased venous thromboembolism (VTE) risk following a major fracture requiring surgical treatment. Additionally, we have used serial TEG analysis to quantify the prolonged hypercoagulable state and increased VTE risk that ensues following a hip fracture. Recently developed cartridge-based platelet mapping (PLM) using TEG analysis can be used to activate platelets at either the adenosine diphosphate (ADP) receptor or at the Thromboxane A2 (AA) receptor, in order to evaluate clot strength when platelets are activated only through those specific receptors. This study aim was to evaluate platelet contribution to hypercoagulability, in order to identify potential therapeutic targets for VTE prevention. We hypothesized that there would be a platelet-predominant contribution to hypercoagulability following a hip fracture.

Patients aged 50 years or older with a hip fracture treated surgically were enrolled in this prospective cohort study. Exclusion criteria were: prior history of VTE, active malignancy, or pre-injury therapeutic dose anticoagulation. Serial TEG and PLM analyses were performed at admission, post-operative day (POD) 1, 3, 5, 7 and at 2-, 4-, 6- and 12-weeks post-operatively. All patients received thromboprophylaxis with low molecular weight heparin (LMWH) for 28 days post-operatively. Hypercoagulability was defined as maximal amplitude (MA; a measure of clot strength) over 65mm based on TEG analysis. Independent samples t-tests were used to compare MA values with this previously established threshold and a mixed effects linear regression model was used to compare MA values over time. Independent samples t-tests and Chi-sqaured analyses were used to compare between the surgical fixation and arthroplasty groups.

Forty-six patients with an acute hip fracture were included, with a mean age of 77.1 (SD = 10.6) years, with 61% (N=11) being female. Twenty-six were treated with arthroplasty (56.5%), while the remainder underwent surgical fixation of their hip fractures. TEG analysis demonstrated post-operative hypercoagulability (mean MA over 65mm) at all follow-up timepoints until 12-weeks. PLM identified a platelet-mediated hypercoagulable state based on elevated ADP-MA and AA-MA, with more pronounced platelet contribution demonstrated by the AA pathway. Patients treated with arthroplasty had significantly increased AA-MA compared with ADP-MA at POD 3 and at the 12-week follow-up.

Thrombelastography can be used to identify hypercoagulability and increased risk for VTE following a hip fracture. Platelet mapping analysis from this pilot study suggests a platelet-mediated hypercoagulable state that may benefit from thromboprophylaxis using an anti-platelet agent that specifically targets the AA platelet activation pathway, such as acetylsalicylic acid (ASA). This research also supports differences in hypercoagulability between patients treated with arthroplasty compared to those who undergo fracture fixation.

Functional outcomes are commonly reported in studies of musculoskeletal oncology patients undergoing limb salvage surgery; however, interpretation requires knowledge of the smallest amount of improvement that is important to patients – the minimally important difference (MID). We established the MIDs for the Musculoskeletal Tumor Society Rating Scale (MSTS) and Toronto Extremity Salvage Score (TESS) in patients with bone tumors undergoing lower limb salvage surgery.

This study was a secondary analysis of the recently completed PARITY (Prophylactic Antibiotic Regimens in Tumor Surgery) study. This data was used to calculate: (1) the anchor-based MIDs using an overall function scale and a receiver operating curve analysis, and (2) the distribution-based MIDs based on one-half of the standard deviation of the change scores from baseline to 12-month follow-up, for both the MSTS and TESS.

There were 591 patients available for analysis. The Pearson correlation coefficients for the association between changes in MSTS and TESS scores and changes in the external anchor scores were 0.71 and 0.57, indicating “high” and “moderate” correlation. Anchor-based MIDs were 12 points and 11 points for the MSTS and TESS, respectively. Distribution-based calculations yielded MIDs of 16-17 points for the MSTS and 14 points for the TESS.

The current study proposes MID scores for both the MSTS and TESS outcome measures based on 591 patients with bone tumors undergoing lower extremity endoprosthetic reconstruction. These thresholds will optimize interpretation of the magnitude of treatment effects, which will enable shared decision-making with patients in trading off desirable and undesirable outcomes of alternative management strategies. We recommend anchor-based MIDs as they are grounded in changes in functional status that are meaningful to patients.

Metastatic bone disease (MBD) is a significant contributor to diminished quality of life in cancer patients, often leading to pathologic fractures, hypercalcaemia, intractable bone pain, and reduced functional independence. Standard of care management for MBD patients undergoing orthopaedic surgery is multi-disciplinary, includes regular surgical follow-up, case by case assessment for use of bone protective medications, and post-operative radiation therapy to the operative site. The number of patients in southern Alberta receiving standard of care post-operative management is currently unclear. Our aim is to develop a database of all patients in southern Alberta undergoing orthopaedic surgery for MBD and to assess for deficiencies and opportunities to ensure standard of care for this complex patient population.

Patients were identified for database inclusion by a search query of the Alberta Cancer Registry of all patients with a diagnosis of metastatic cancer who underwent surgery for an impending or pathologic fracture in the Calgary, South and Central Alberta Zones. Demographic information, primary cancer history, previous local and systemic treatments, anatomical location of MBD event(s), surgical fixation techniques, and post-operative care details were collected. The rate of standard of care post-operative treatment was evaluated. A comparison of outcomes between tertiary urban centres and rural centres was also completed. Survival was calculated from time of first operation to date of death. Univariate and multivariate analyses were performed to identify the impact of post-operative care variables on survival amongst patients surviving longer than one month.

We identified 402 patients who have undergone surgical treatment for MBD in southern Alberta from 2006-2018. Median age at time of surgery was 66.3 years and 52.7% of patients were female. Breast, lung, prostate, renal cell and multiple myeloma were the most common primary malignancies (n=328, 81.6%). Median post-operative survival was 6.8 months (95%CI: 5.7-8.3). 203 patients (52.5%) were treated with post-operative radiotherapy and 159 patients (50.8%) had post-operative surgical follow-up. Only 39 patients (11.3%) received bone protective agents in the peri-operative period. On multivariate survival analysis, post-operative surgical follow-up was associated with improved survival (p<0.001). Patients were treated at nine hospitals across southern Alberta with most patients treated in an urban center (65.9%). Post-operative survival was significantly longer amongst patients treated in an urban center (9.0 months, 95%CI: 6.9-12.3 versus 4.3 months, 95%CI: 3.4-5.6, p<0.001).

The burden of MBD is significant and increasing. With treatment occurring at multiple provincial sites, there is a need for standardized, primary disease-specific peri- and post-operative protocols to ensure quality and efficacious patient care. To provide evidence informed treatment recommendations, we have developed a database of all patients in southern Alberta undergoing orthopaedic surgery for MBD. Our results demonstrate that many patients were not treated according to post-operative standard of care recommendations. Notably, half of the included patients did not have documented surgical follow-up, post-operative radiation treatment was low and only 11% were actively treated with bone protective agents. This data justifies the need for established surgical MBD care pathways and provides reference data to benchmark prospective QA and QI outcomes in this patient population.

Ligament reconstruction following multi-ligamentous knee injuries involves graft fixation in bone tunnels using interference screws (IS) or cortical suspensory systems. Risks of IS fixation include graft laceration, cortical fractures, prominent hardware, and inability to adjust tensioning once secured. Closed loop suspensory (CLS) fixation offers an alternative with fewer graft failures and improved graft-to-tunnel incorporation. However, graft tensioning cannot be modified to accommodate errors in tunnel length evaluation. Adjustable loop suspensory (ALS) devices (i.e., Smith & Nephew Ultrabutton) address these concerns and also offer the ability to sequentially tighten each graft, as needed. However, ALS devices may lead to increased graft displacement compared to CLS devices. Therefore, this study aims to report outcomes in a large clinical cohort of patients using both IS and CLS fixation.

A retrospective review of radiographic, clinical, and patient-reported outcomes following ligament reconstruction from a Level 1 trauma centre was completed. Eligible patients were identified via electronic medical records using ICD-10 codes. Inclusion criteria were patients 18 years or older undergoing ACL, PCL, MCL, and/or LCL reconstruction between January 2018 and 2020 using IS and/or CLS fixation, with a minimum of six-month post-operative follow-up. Exclusion criteria were follow-up less than six months, incomplete radiographic imaging, and age less than 18 years. Knee dislocations (KD) were classified using the Schenck Classification. The primary outcome measure was implant removal rate. Secondary outcomes were revision surgery rate, deep infection rate, radiographic fixation failure rate, radiographic malposition, Lysholm and Tegner scores, clinical graft failure, and radiographic graft failure. Radiographic malposition was defined as implants over 5 mm off bone or intraosseous deployment of the suspensory fixation device. Clinical graft failure was defined as a grade II or greater Lachman, posterior drawer, varus opening at 20° of knee flexion, and/or valgus opening at 20° of knee flexion. Radiographic failure was defined when over 5 mm, 3.2 mm, and/or 2.7 mm of side-to-side difference occurred using PCL gravity stress views, valgus stress views, and/or varus stress views, respectively. Descriptive statistics were used.

Sixty-three consecutive patients (mean age = 41 years, range = 19-58) were included. A total of 266 CLS fixation with Ultrabuttons and 135 IS were used. Mean follow-up duration was 383 days. Most injuries were KD type II and III. Graft revision surgery rate was 1.5%. Intraosseous deployment occurred in 6.2% and 17% had implants secured in soft tissue, rather than on bone. However, the implant removal rate was only 6.2%. Radiographic PCL gravity stress views demonstrated an average of 1.2 mm of side-to-side difference with 6.2% meeting criteria for radiographic failure. A single patient met radiographic failure criteria for collateral grafts. Mean Lysholm and Tegner scores were 87.3 and 4.4, respectively, with follow-up beyond one year.

Both IS and CLS fixation demonstrate an extremely low revision surgery rate, a high rate of implant retention, excellent radiographic stability, and satisfactory patient-reported outcome scores.

Incorrect implant deployment was seen in a total of 17% of patients, yet none required implant removal. A single patient required graft revision due to implant failure.

Dual plate constructs have become an increasingly common fixation technique for midshaft clavicle fractures and typically involve the use of mini-fragment plates. The goal of this technique is to reduce plate prominence and implant irritation, as these are common reasons for revision surgery. However, limited biomechanical data exist for these lower-profile constructs. The study aim was to compare dual mini-fragment orthogonal plating to traditional small-fragment clavicle plates for biomechanical non-inferiority and to determine if an optimal plate configuration could be identified, using a cadaveric model.

Twenty-four cadaveric clavicles were randomized to one of six groups (n=4 per group), stratified by CT-based bone mineral content (BMC). The six different plating configurations compared were: pre-contoured superior or anterior fixation using a single 3.5-mm LC-DC plate, and four different dual-plating constructs utilizing 2.4-mm and 2.7-mm reconstruction or LC-DC plates. The clavicles were plated and then osteotomized to create an inferior butterfly fracture, which was then fixed with a single interfragmentary screw (OTA 15.2B). Axial, torsional, and bending (anterior and superior surface loading) stiffness were determined for each construct through non-destructive cyclic testing, using an MTS 858 Bionix materials testing system. This was followed by a load-to-failure test in three-point superior-surface bending. Kruskal-Wallace H and Mann-Whitney U were used to test for statistical significance.

There were no significant differences in BMC (median 7.9 g, range 4.2-13.8 g) for the six groups (p=1.000). For axial stiffness, the two dual-plate constructs with a superior 2.4-mm and anterior 2.7-mm plate (either reconstruction or LC-DC) were significantly stiffer than the other four constructs (p=0.021). For both superior and anterior bending, the superior 2.4-mm and anterior 2.7-mm plate constructs were significantly stiffer when compared to the 3.5-mm superior plate (p=0.043). In addition, a 3.5-mm plate placed anterior was a stiffer construct than a superior 3.5-mm plate (p=0.043). No significant differences were found in torsional stiffness or load-to-failure between the different constructs.

Dual plating using mini-fragment plates is biomechanically superior for fixation of midshaft clavicle fractures when compared to a single superior 3.5-mm plate and has similar biomechanical properties to a 3.5-mm plate placed anteriorly. With the exception of axial stiffness, no significant differences were found when different dual plating constructs were compared to each other. However, placing a 2.4-mm plate superiorly in combination with a 2.7-mm plate anteriorly might be the optimal construct, given the biomechanical superiority over the 3.5-mm plate placed superior.

Guidelines for the use of preoperative blood tests for elective surgery were established. However, there is less evidence and no guidelines regarding using these tests when a young, healthy patient undergoes minor orthopaedic trauma surgery. Bloodwork is often ordered routinely, regardless of medical history or the nature of the injury. We hypothesized that unnecessary blood work is requested for younger pre-operative patients, and their results will not change peri-operative management. This practice is not a judicious use of healthcare resources. This study aimed to evaluate the frequency, type, cost, and impact on clinical decisions if standard preoperative bloodwork was completed in healthy patients requiring surgical management of a minor fracture or dislocation.

After the approval of our institutional ethics board, a retrospective chart review was conducted. Inclusion criteria were patients aged 18-60 years, who had an isolated minor orthopaedic trauma requiring outpatient surgery, who were American Society of Anesthesiologists (ASA) class 1. ASA class 1 is defined as “a normal healthy patient, without any clinically important comorbidity and without a clinically significant past/present medical history.” Data records from January 1, 2016, to December 31, 2018, were extracted from a provincial database (the Analytics Data Integration, Measurement and Reporting) for five hospitals. Data including demographics, surgical treatment, type and number of blood tests ordered, and ordering physician were collected. Any abnormal test results were checked to see whether they led to a change in patient management or related to a postoperative adverse event. Independent samples t-tests and Chi-square tests were used to compare the characteristics of patients who had preoperative bloodwork versus those who did not. The cost of preoperative blood work was estimated.

During these two years, 627 patients met inclusion criteria, and 27% (n=168) of these patients had bloodwork completed pre-operatively, while only 34% (n=57) of these had one or more abnormal laboratory parameters. These abnormalities were minor and did not alter clinical management or result in repeated bloodwork peri-operatively. Patients who had bloodwork were significantly older (40.2 years) compared with patients without preoperative blood work (37.8 years; p=0.03), but there was no difference in sex between those who had bloodwork (53.4% male) and those who did not (51.4% male; p=0.63). The most common blood test ordered was a complete blood count, and the most commonly abnormal result was a mildly elevated white blood cell count (19%; n= 29). The most common patients to receive bloodwork were those with ankle (34%) and distal radius (34%) fractures. The bloodwork was primarily ordered by clinical associates (26%; n=46) and emergency department physicians (22%; n=38). Without considering lab personnel, consumables, and analysis time, the cost of this bloodwork was approximately $7685, an average of $45 per patient.

Pre-operative bloodwork in young, healthy, asymptomatic patients requiring outpatient surgery for minor orthopaedic trauma had no clinical significance and did not change patient management. Rigorous prospective research is warranted to establish national guidelines for appropriate pre-operative bloodwork ordering to minimize unnecessary and costly investigations.

The number of women entering medical school has been steadily increasing over the past two decades; however, the number of women pursuing careers in orthopaedic surgery has not increased at the same rate. One of the suggested reasons for this discrepancy is the perceived incompatibility of having a family while upholding the demands of a surgical career in orthopaedics. A growing body of scientific literature has also outlined the increased rate of infertility and pregnancy complications in women surgeons. The extent to which these factors play a role in the recruitment and retention of women in orthopaedic surgery is unknown. Understanding pregnancy and parenthood in orthopaedic surgery is a critical first step in addressing this issue.

A scoping review was conducted to identify literature pertaining to the perceptions and experiences of pregnancy and/or parenthood of women in orthopaedic surgery. Embase, MEDLINE and PsychINFO were searched on June 7th, 2021 with Boolean operators to combine the following terms: orthop?e*, pregnancy, maternity, motherhood, parenthood, parental, and parenting. Studies pertaining to orthopaedic surgery residents, fellows and staff were included. The Arksey and O'Malley framework for scoping studies was followed. Descriptive statistics were used to quantify the included studies while thematic analysis as described by Braun and Clarke was used to analyze the qualitative data.

A total of 17 studies from 2006 to 2021 met inclusion criteria. Over half of the available research was conducted within the last two years (n=9, 53%). The majority of studies were conducted in the United States (n=15, 88%) and the United Kingdom (n=2, 12%). The most commonly used study design was survey-based research (n=13, 76%), followed by review studies (n=3, 18%), and case series (n=1, 6%). Thematic analysis revealed five key themes contributing to the women's experiences of pregnancy and/or parenthood in orthopaedics: (1) women are subtly or blatantly discouraged from becoming pregnant by their colleagues and superiors, (2) women delay childbearing to preserve their professional reputation, (3) there are higher rates of infertility and preterm labor in orthopaedic surgeons than in the general population, (4) the orthopaedic work environment can be hazardous and challenging for the pregnant woman, but accommodations are possible to mitigate risks, and (5) overall, there is limited support for pregnant and/or parenting women in orthopaedics throughout their career.

The first woman to be board-certified in orthopaedic surgery in the United States was Ruth Jackson in 1937. Eighty-four years later, orthopaedic surgery has the lowest number of women of the surgical specialties. The barriers related to pregnancy and/or parenthood during a woman's career in orthopaedics may be one cause. This study identified five themes related to pregnancy and parenthood that warrant further investigation. Qualitative research approaches can be used to elucidate the details of women's experiences and to provide suggestions for structural changes in the orthopaedic work environment.

Prolonged bedrest in hospitalized patients is a major risk factor for venous thromboembolism (VTE), especially in high risk patients with hip fracture. Thrombelastography (TEG) is a whole blood viscoelastic hemostatic assay with evidence that an elevated maximal amplitude (MA), a measure of clot strength, is predictive of VTE in orthopaedic trauma patients. The objective of this study was to compare the TEG MA parameter between patients with hip fracture who were more mobile post-operatively and discharged from hospital early to patients with hip fracture with reduced mobility and prolonged hospitalizations post-operatively.

In this prospective cohort study, TEG analysis was performed in patients with hip fracture every 24-hours from admission until post-operative day (POD) 5, then at 2- and 6-weeks post-operatively. Hypercoagulability was defined by MA > 65. Patients were divided into an early (within 5-day) and late (after 5-day) discharge group, inpatient at 2-weeks group, and discharge to MSK rehabilitation (MSK rehab), and long term care (LTC) groups. Two-sample t-test was used to analyze differences in MA between the early discharge and less mobile groups. All statistical tests were two-sided, and p-values < 0.05 were considered statistically significant.

In total, 121 patients with a median age of 81.0 were included. Patients in the early discharge group (n=15) were younger (median age 64.0) and more likely to ambulate without gait aids pre-injury (86.7%) compared to patients in the late discharge group (n=105), inpatients at 2-weeks (n=48), discharged to MSK rehab (n=30), and LTC (n=20). At two weeks post-operative, the early discharge group was significantly less hypercoagulable (MA=68.9, SD 3.0) compared to patients in the other four groups. At 6-weeks post-operative, the early discharge group was the only group to demonstrate a trend towards mean MA below the MA > 65 hypercoagulable threshold (MA=64.4, p=0.45). Symptomatic VTE events were detected in three patients (2.5%) post-operatively. All three patients had hospitalizations longer than five days after surgery.

In conclusion, our analysis of hypercoagulability secondary to reduced post-operative mobility demonstrates that patients with hip fracture who were able to mobilize independently sooner after hip fracture surgery, have a reduced peak hypercoagulable state. In addition, there is a trend towards earlier return to normal coagulation status as determined by the TEG MA parameter. Post-operative mobility status may play a role in determining individualized duration of thromboprophylaxis following hip fracture surgery. Future studies comparing TEG to clinically validated mobility tools may more closely evaluate the contribution of venous stasis due to reduced mobility on hypercoagulation following hip fracture surgery.

Distal radius fractures (DRFs) are common injuries that represent 17% of all adult upper extremity fractures. Some fractures deemed appropriate for nonsurgical management following closed reduction and casting exhibit delayed secondary displacement (greater than two weeks from injury) and require late surgical intervention. This can lead to delayed rehabilitation and functional outcomes. This study aimed to determine which demographic and radiographic features can be used to predict delayed fracture displacement.

This is a multicentre retrospective case-control study using radiographs extracted from our Analytics Data Integration, Measurement and Reporting (DIMR) database, using diagnostic and therapeutic codes. Skeletally mature patients aged 18 years of age or older with an isolated DRF treated with surgical intervention between two and four weeks from initial injury, with two or more follow-up visits prior to surgical intervention, were included. Exclusion criteria were patients with multiple injuries, surgical treatment with fewer than two clinical assessments prior to surgical treatment, or surgical treatment within two weeks of injury. The proportion of patients with delayed fracture displacement requiring surgical treatment will be reported as a percentage of all identified DRFs within the study period. A multivariable conditional logistic regression analysis was used to assess case-control comparisons, in order to determine the parameters that are mostly likely to predict delayed fracture displacement leading to surgical management. Intra- and inter-rater reliability for each radiographic parameter will also be calculated.

A total of 84 age- and sex-matched pairs were identified (n=168) over a 5-year period, with 87% being female and a mean age of 48.9 (SD=14.5) years. Variables assessed in the model included pre-reduction and post-reduction radial height, radial inclination, radial tilt, volar cortical displacement, injury classification, intra-articular step or gap, ulnar variance, radiocarpal alignment, and cast index, as well as the difference between pre- and post-reduction parameters. Decreased pre-reduction radial inclination (Odds Ratio [OR] = 0.54; Confidence Interval [CI] = 0.43 – 0.64) and increased pre-reduction volar cortical displacement (OR = 1.31; CI = 1.10 – 1.60) were significant predictors of delayed fracture displacement beyond a minimum of 2-week follow-up. Similarly, an increased difference between pre-reduction and immediate post reduction radial height (OR = 1.67; CI = 1.31 – 2.18) and ulnar variance (OR = 1.48; CI = 1.24 – 1.81) were also significant predictors of delayed fracture displacement.

Cast immobilization is not without risks and delayed surgical treatment can result in a prolong recovery. Therefore, if reliable and reproducible radiographic parameters can be identified that predict delayed fracture displacement, this information will aid in earlier identification of patients with DRFs at risk of late displacement. This could lead to earlier, appropriate surgical management, rehabilitation, and return to work and function.

Fractures of the humeral diaphysis occur in a bimodal distribution and represent 3-5% of all fractures. Presently, the standard treatment of isolated humeral diaphyseal fractures is nonoperative care using splints, braces, and slings. Recent data has questioned the effectiveness of this strategy in ensuring fracture healing and optimal patient function. The primary objective of this randomized controlled trial (RCT) was to assess whether operative treatment of humeral shaft fractures with a plate and screw construct provides a better functional outcome than nonoperative treatment. Secondary objectives compared union rates and both clinical and patient-reported outcomes.

Eligible patients with an isolated, closed humeral diaphyseal fracture were randomized to either nonoperative care (initial sugar-tong splint, followed by functional coaptation brace) or open reduction and internal fixation (ORIF; plate and screw construct). The primary outcome measure was the Disability Shoulder, Arm, Hand (DASH) score assessed at 2-, 6-, 16-, 24-, and 52-weeks. Secondary outcomes included the Short Musculoskeletal Functional Assessment (SMFA), the Constant Shoulder Score, range of motion (ROM), and radiographic parameters. Independent samples t-tests and Chi-squared analyses were used to compare treatment groups. The DASH, SMFA, and Constant Score were modelled over time using a multiple variable mixed effects model.

A total of 180 patients were randomized, with 168 included in the final analysis. There were 84 patients treated nonoperatively and 84 treated with ORIF. There was no significant difference between the two treatment groups for age (mean = 45.4 years, SD 16.5 for nonoperative group and 41.7, SD 17.2 years for ORIF group; p=0.16), sex (38.1% female in nonoperative group and 39.3% female in ORIF group; p=0.87), body mass index (mean = 27.8, SD 8.7 for nonoperative group and 27.2, SD 6.2 for ORIF group; p=0.64), or smoking status (p=0.74). There was a significant improvement in the DASH scores at 6 weeks in the ORIF group compared to the nonoperative group (mean=33.8, SD 21.2 in the ORIF group vs. mean=56.5, SD=21.1 in the nonoperative group; p < 0 .0001). At 4 months, the DASH scores were also significantly better in the ORIF group (mean=21.6, SD=19.7 in the ORIF group vs. mean=31.6, SD=24.6 in the nonoperative group; p=0.009. However, there was no difference in DASH scores at 12-month follow-up between the groups (mean=8.8,SD=10.9 vs. mean=11.0, SD=16.9 in the nonoperative group; p=0.39). Males had improved DASH scores at all timepoints compared with females. There was significantly quicker time to union (p=0.016) and improved position (p < 0 .001) in the ORIF group. There were 13 (15.5%) nonunions in the nonoperative group and four (4.7%) combined superficial and deep infections in the ORIF group. There were seven radial nerve palsies in the nonoperative group and five (a single iatrogenic) radial nerve palsies in the ORIF group.

This large RCT comparing operative and nonoperative treatment of humeral diaphyseal fractures found significantly improved functional outcome scores in patients treated surgically at 6 weeks and 4 months. However, the early functional improvement did not persist at the 12-month follow-up. There was a 15.5% nonunion rate, which required surgical intervention, in the nonoperative group and a similar radial nerve palsy rate between groups.

Prolonged bedrest in hospitalized patients is a major risk factor for venous thromboembolism (VTE), especially in high risk patients with hip fracture. Thrombelastography (TEG) is a whole blood viscoelastic hemostatic assay with evidence that an elevated maximal amplitude (MA), a measure of clot strength, is predictive of VTE in orthopaedic trauma patients. The objective of this study was to compare the TEG MA parameter between patients with hip fracture who were more mobile post-operatively and discharged from hospital early to patients with hip fracture with reduced mobility and prolonged hospitalizations post-operatively.

In this prospective cohort study, TEG analysis was performed in patients with hip fracture every 24-hours from admission until post-operative day (POD) 5, then at 2- and 6-weeks post-operatively. Hypercoagulability was defined by MA > 65. Patients were divided into an early (within 5-day) and late (after 5-day) discharge group, inpatient at 2-weeks group, and discharge to MSK rehabilitation (MSK rehab), and long term care (LTC) groups. Two-sample t-test was used to analyze differences in MA between the early discharge and less mobile groups. All statistical tests were two-sided, and p-values < 0.05 were considered statistically significant.

In total, 121 patients with a median age of 81.0 were included. Patients in the early discharge group (n=15) were younger (median age 64.0) and more likely to ambulate without gait aids pre-injury (86.7%) compared to patients in the late discharge group (n=105), inpatients at 2-weeks (n=48), discharged to MSK rehab (n=30), and LTC (n=20). At two weeks post-operative, the early discharge group was significantly less hypercoagulable (MA=68.9, SD 3.0) compared to patients in the other four groups. At 6-weeks post-operative, the early discharge group was the only group to demonstrate a trend towards mean MA below the MA > 65 hypercoagulable threshold (MA=64.4, p=0.45). Symptomatic VTE events were detected in three patients (2.5%) post-operatively. All three patients had hospitalizations longer than five days after surgery.

In conclusion, our analysis of hypercoagulability secondary to reduced post-operative mobility demonstrates that patients with hip fracture who were able to mobilize independently sooner after hip fracture surgery, have a reduced peak hypercoagulable state. In addition, there is a trend towards earlier return to normal coagulation status as determined by the TEG MA parameter. Post-operative mobility status may play a role in determining individualized duration of thromboprophylaxis following hip fracture surgery. Future studies comparing TEG to clinically validated mobility tools may more closely evaluate the contribution of venous stasis due to reduced mobility on hypercoagulation following hip fracture surgery.

Heterotopic ossification (HO) is a well-known complication of traumatic elbow injuries. The reported rates of post-traumatic HO formation vary from less than 5% with simple elbow dislocations, to greater than 50% in complex fracture-dislocations. Previous studies have identified fracture-dislocations, delayed surgical intervention, and terrible triad injuries as risk factors for HO formation. There is, however, a paucity of literature regarding the accuracy of diagnosing post-traumatic elbow HO. Therefore, the purpose of our study was to determine the inter-rater reliability of HO diagnosis using standard radiographs of the elbow at 52 weeks post-injury, as well as to report on the rate of mature compared with immature HO. We hypothesized inter-rater reliability would be poor among raters for HO formation.

Prospectively collected data from a large clinical trial was reviewed by three independent reviewers (one senior orthopedic resident, one senior radiology resident, and one expert upper extremity orthopedic surgeon). Each reviewer examined anonymized 52-week post-injury radiographs of the elbow and recorded: 1. the presence or absence of HO, 2. the location of HO, 3. the size of the HO (in cm, if present), and 4. the maturity of the HO formation. Maturity was defined by consensus prior to image review and defined as an area of well-defined cortical and medullary bone outside the cortical borders of the humerus, ulna, or radius. Immature lesions were defined as an area of punctate calcification with an ill-defined cloud-like density outside the cortical borders of the humerus, ulna or radius. Data were collected using a standardized online data collection form (CognizantMD, Toronto, ON, CA). Inter-rater reliability was calculated using Fleiss’ Kappa statistic and a multivariate logistic regression analysis was performed to identify risk factors for HO formation in general, as well as mature HO at 52 weeks post injury. Statistical analysis was performed using RStudio (version1.4, RStudio, Boston, MA, USA).

A total of 79 radiographs at the 52-week follow-up were reviewed (54% male, mean age 50, age SD 14, 52% operatively treated). Inter-rater reliability using Fleiss’ Kappa was k= 0.571 (p = 0.0004) indicating moderate inter-rater reliability among the three reviewers. The rate of immature HO at 52 weeks was 56%. The multivariate logistic regression analysis identified male sex as a significant risk factor for HO development (OR 5.29, 1.55-20.59 CI, p = 0.011), but not for HO maturity at 52 weeks. Age, time to surgery, and operative intervention were not found to be significant predictors for either HO formation or maturity of the lesion in this cohort.

Our study demonstrates moderate inter-rater reliability in determining the presence of HO at 52 weeks post-elbow injury. There was a high rate (56%) of immature HO at 52-week follow-up. We also report the finding of male sex as a significant risk factor for post traumatic HO development. Future research directions could include investigation into possible male predominance for traumatic HO formation, as well as improving inter-rater reliability through developing a standardized and validated classification system for reporting the radiographic features of HO formation around the elbow.

Major orthopaedic fractures are an independent risk factor for the development of venous thromboembolism (VTE), which are significant causes of preventable morbidity and mortality in trauma patients. Despite thromboprophylaxis, patients who sustain a pelvic or acetabular fracture (PA) continue to have high rates of VTE (12% incidence). Thrombelastography (TEG) is a whole-blood, point-of-care test which provides an overview of the clotting process. Maximal amplitude (MA), from TEG analysis, is the measure of clot strength and values ≥65mm have been used to quantify hypercoagulability and increased VTE risk. Therefore, the primary aim was to use serial TEG analysis to quantify the duration of hypercoagulability, following surgically treated PA fractures.

This is a single centre, prospective cohort study of adult patients 18 years or older with surgically treated PA fractures. Consecutive patients were enrolled from a Level I trauma centre and blood draws were taken over a 3-month follow-up period for serial TEG analysis. Hypercoagulability was defined as MA ≥65mm. Exclusion criteria: bleeding disorders, active malignancy, current therapeutic anticoagulation, burns (>20% of body surface) and currently, or expecting to become pregnant within study timeframe.

Serial TEG analysis was performed using a TEG6s hemostasis analyzer (Haemonetics Corp.) upon admission, pre-operatively, on post-operative day (POD) 1, 3, 5, 7 (or until discharged from hospital, whichever comes sooner), then in follow-up at 2-, 4-, 6-weeks and 3-months post-operatively. Patients received standardized thromboprophylaxis with low molecular weight heparin for 28 days post-operatively. VTE was defined as symptomatic DVT or PE, or asymptomatic proximal DVT, and all participants underwent a screening post-operative lower extremity Doppler ultrasound on POD3. Descriptive statistics were used to determine the association between VTE events and MA values. For the primary outcome measure, the difference between the MA threshold value (≥65mm) and serial MA measures, were compared using one-sided t-tests (α=0.05).

Twenty-eight patients (eight females, 29%) with a mean age of 48±18 years were included. Acetabular fractures were sustained by 13 patients (46%), pelvic fractures by 14 patients (50%), and one patient sustained both. On POD1, seven patients (25%) were hypercoagulable, with 21 patients (78%) being hypercoagulable by POD3, and 17 patients (85%) by POD5. The highest average MA values (71.7±3.9mm) occurred on POD7, where eight patients (89%) were hypercoagulable. At 2-weeks post-operatively, 16 patients (94%) were hypercoagulable, and at four weeks, when thromboprophylaxis was discontinued, six patients (40%) remained hypercoagulable. Hypercoagulability persisted for five patients (25%) at 6-weeks and for two patients (10%) by three months.

There were six objectively diagnosed VTE events (21.4%), five were symptomatic, with a mean MA value of 69.3mm±4.3mm at the time of diagnosis. Of the VTE events, four occurred in participants with acetabular fractures (three male, 75%) and two in those with pelvic fractures (both males).

At 4-weeks post-operatively, when thromboprophylaxis is discontinued, 40% of patients remained hypercoagulable and likely at increased risk for VTE. At 3-months post-operatively, 10% of the cohort continued to be hypercoagulable. Serial TEG analysis warrants further study to help predict VTE risk and to inform clinical recommendations following PA fractures.

Surgical management for acute or impending pathologic fractures in metastatic bone disease (MBD) places patients at high-risk for post-operative venous thromboembolism (VTE). Due to the combination of malignancy, systemic cancer treatment, and surgical treatment, VTE-risk is increased 7-fold in patients with MBD compared to non-cancer patients undergoing the same procedure. The extent and duration of post-operative hypercoagulability in patients with MBD remains unknown and thromboprophylaxis guidelines were developed for non-cancer patients, limiting their applicability to address the elevated VTE-risk in cancer patients. Thrombelastography (TEG) analysis is a point-of-care test that measures clot formation, stabilization, and lysis in whole blood samples. The TEG parameter, maximal amplitude (MA), indicates clot strength and the threshold of ≥65 mm has been used to define hypercoagulability and predict VTE events in non-cancer patients requiring orthopaedic surgery. Therefore, this study aims to quantify the extent and duration of post-operative hypercoagulability in patients with MBD using serial TEG analysis.

Consecutive adults (≥18 years) with MBD who required orthopaedic surgery for acute or impending pathologic fractures were enrolled into this single-centre, prospective cohort study. Serial TEG analysis was performed onsite using a TEG®6s haemostasis analyzer (Haemonetics Corporation, Boston, MA) on whole blood samples collected at seven timepoints: pre-operatively; on post-operative day (POD) 1, 3, and 5; and at 2-, 6-, and 12-weeks post-operatively. Hypercoagulability was defined as MA ≥65 mm. Participants received standardized thromboprophylaxis for four weeks and patient-reported compliance with thromboprophylaxis was recorded. VTE was defined as symptomatic DVT or PE, or asymptomatic proximal DVT, and all participants underwent a screening post-operative lower extremity Doppler ultrasound on POD3. Descriptive statistics were performed and difference between pre-operative MA values of participants with VTE versus no VTE was evaluated using Student's t-test (p≤0.05).

Twenty-one participants (10 female; 47.6%) with a mean age of 70 ± 12 years were enrolled. Nine different primary cancers were identified amongst participants, with breast (23.8%), colorectal (19.0%), and lung cancer (14.3%) most frequently reported. Most participants (57.1%) were hypercoagulable pre-operatively, and nearly half remained hypercoagulable at 6- and 12-weeks post-operatively (47.1 and 46.7%, respectively). VTE occurred in 5 patients (23.8%) and mean MA was 68.1 ± 4.6 mm at the time of diagnosis. Mean pre-operative MA values were significantly higher (p=0.02) in patients who experienced VTE (68.9 ± 3.5 mm) compared to those who did not (62.7 ± 6.5 mm). VTE incidence was highest in the first week post-operatively, during which time four VTE events (80%) occurred. The proportion of patients in a hypercoagulable state increased at three consecutive timepoints, beginning on POD3 (85.0%), increasing on POD5 (87.5%), and peaking at 2-weeks post-operatively (88.9%).

Current thromboprophylaxis guidelines do not consider cancer-associated risk factors that contribute to increased VTE incidence and prescription duration may be inadequate to address prolonged post-operative hypercoagulability in patients with MBD. The high rate of VTE events observed and sustained hypercoagulable state indicate that thromboprophylaxis may be prematurely terminated while patients remain at high risk for VTE. Therefore, extending thromboprophylaxis duration beyond 4-weeks post-operatively in patients with MBD warrants further investigation.

Fractures of the humeral diaphysis occur in a bimodal distribution and represent 3-5% of all fractures. Presently, the standard treatment of isolated humeral diaphyseal fractures is nonoperative care using splints, braces, and slings. Recent data has questioned the effectiveness of this strategy in ensuring fracture healing and optimal patient function. The primary objective of this randomized controlled trial (RCT) was to assess whether operative treatment of humeral shaft fractures with a plate and screw construct provides a better functional outcome than nonoperative treatment. Secondary objectives compared union rates and both clinical and patient-reported outcomes.

Eligible patients with an isolated, closed humeral diaphyseal fracture were randomized to either nonoperative care (initial sugar-tong splint, followed by functional coaptation brace) or open reduction and internal fixation (ORIF; plate and screw construct). The primary outcome measure was the Disability Shoulder, Arm, Hand (DASH) score assessed at 2-, 6-, 16-, 24-, and 52-weeks. Secondary outcomes included the Short Musculoskeletal Functional Assessment (SMFA), the Constant Shoulder Score, range of motion (ROM), and radiographic parameters. Independent samples t-tests and Chi-squared analyses were used to compare treatment groups. The DASH, SMFA, and Constant Score were modelled over time using a multiple variable mixed effects model.

A total of 180 patients were randomized, with 168 included in the final analysis. There were 84 patients treated nonoperatively and 84 treated with ORIF. There was no significant difference between the two treatment groups for age (mean = 45.4 years, SD 16.5 for nonoperative group and 41.7, SD 17.2 years for ORIF group; p=0.16), sex (38.1% female in nonoperative group and 39.3% female in ORIF group; p=0.87), body mass index (mean = 27.8, SD 8.7 for nonoperative group and 27.2, SD 6.2 for ORIF group; p=0.64), or smoking status (p=0.74). There was a significant improvement in the DASH scores at 6 weeks in the ORIF group compared to the nonoperative group (mean=33.8, SD 21.2 in the ORIF group vs. mean=56.5, SD=21.1 in the nonoperative group; p < 0 .0001). At 4 months, the DASH scores were also significantly better in the ORIF group (mean=21.6, SD=19.7 in the ORIF group vs. mean=31.6, SD=24.6 in the nonoperative group; p=0.009. However, there was no difference in DASH scores at 12-month follow-up between the groups (mean=8.8,SD=10.9 vs. mean=11.0, SD=16.9 in the nonoperative group; p=0.39). Males had improved DASH scores at all timepoints compared with females. There was significantly quicker time to union (p=0.016) and improved position (p < 0 .001) in the ORIF group. There were 13 (15.5%) nonunions in the nonoperative group and four (4.7%) combined superficial and deep infections in the ORIF group. There were seven radial nerve palsies in the nonoperative group and five (a single iatrogenic) radial nerve palsies in the ORIF group.

This large RCT comparing operative and nonoperative treatment of humeral diaphyseal fractures found significantly improved functional outcome scores in patients treated surgically at 6 weeks and 4 months. However, the early functional improvement did not persist at the 12-month follow-up. There was a 15.5% nonunion rate, which required surgical intervention, in the nonoperative group and a similar radial nerve palsy rate between groups.

Flexible fixation techniques combined with anatomic (open) syndesmosis reduction have demonstrated improved functional outcomes and rates of malreduction. Suture-button devices allow physiologic motion of the syndesmosis without need for implant removal, which may lower the risk of recurrent syndesmotic diastasis. There is limited longer-term assessment of the maintenance of reduction between static and flexible syndesmotic fixation using bilateral ankle CT evaluation.

This is an a priori planned subgroup analysis of a multi-centre, randomized clinical trial comparing static syndesmosis fixation (two 3.5 mm screws) with flexible fixation (single knotless Tightrope) for patients with AO- OTA 44-C injuries. Patients who completed bilateral ankle CT scans at 3- and 12-month follow-up were included. The primary outcome measure was syndesmotic malreduction based on bilateral ankle CT scans, using the uninjured, contralateral ankle as a control. Anterior (ASD), middle (MSD), and posterior (PSD) syndesmosis distance were calculated to measure syndesmosis reduction. Secondary outcomes included re-operation, adverse events and functional outcomes including the EQ5D, Olerud-Molander Ankle Score (OM), Foot and Ankle Disability Index (FADI), and Work Productivity Activity Impairment Questionnaire (WPAI). Paired samples t-tests were used to compare injured to control ankles (R, v 3.5.1).

42 patients (24 Group S, 18 Group T) were included. ASD for Group T was 5.22mm (95%CI 4.69–5.77) at 3 months compared to 4.26mm (95%CI 3.82–4.71; p=0.007) in controls and 5.38mm (95%CI 4.72–6.04) at 12 months compared to 4.44mm (95%CI 3.73–5.16; p=0.048) in controls. ASD for Group S was 4.63mm (95%CI 4.17– 5.10) at 3 months compared to 4.67mm (95%CI 4.24–5.10; p=0.61) in controls, but significantly increased to 5.73mm (95%CI 4.81–6.66) at 12 months compared to 4.65mm (95%CI 4.15–5.15; p=0.04) in controls. MSD results were similar; Group T had a larger MSD than control ankles at 3 months (p=0.03) and 12 months (p=0.01), while the MSD in Group S was not different at 3 months (p=0.80) but increased at 12 months (p=<0.01). 88% (21/24) of Group S had broken or removed screws by 12 months. Unplanned re-operation was 15% in Group S and 4% in Group T (p=0.02), with an overall re-operation rate of 30% in Group S. There was no significant difference between treatment groups for EQ-5D, OM, FADI or WPAI at 3- or 12-month follow-up.

Tightrope fixation resulted in greater diastasis of the ASD and MSD compared to contralateral, uninjured ankles at 3- and 12-months post-fixation. Group S initially had syndesmotic reduction similar to control ankles, but between 3- and 12-months post-fixation, there was significantly increased syndesmosis diastasis compared to controls. The majority of Group S (88%) had either broken screws or scheduled screw removal, which may explain the increased tibio-fibular diastasis seen at 12-months.

Given the low prevalence of sarcoma, international cooperation is necessary to recruit sufficient numbers of patients for surgical trials. The PARITY (Prophylactic Antibiotic Regimens in Tumour Surgery) trial is the first international multicentre trial in orthopedic oncology and successfully achieved target enrollment of 600 patients across 12 countries. It is important to reflect upon the challenges encountered and experiences gained to inform future trials. The objective of this study is to describe recruitment patterns and examine the differences in enrollment across different PARITY sites and identify variables associated with varying levels of recruitment.

Data from this study was obtained from the PARITY trial Methods Centre and correspondence data. We performed descriptive statistics to demonstrate the recruitment patterns over time. We compared recruitment, time to set up, and time to enroll the first patient between North American and international sites, and sites that had dedicated research personnel. Two-tailed non-paired t-tests were performed to compare average monthly recruitment rates between groups with significance being set at alpha=0.05.

A total of 600 patients from 48 clinical sites and 12 countries were recruited from January 2013 through to October 2019. Average monthly enrollment increased every year of the study. There were 36 North American and 12 international sites. North American sites were able to set up significantly faster than international sites (19.3 vs. 28.3 months p=0.037). However, international sites had a significantly higher recruitment rate per month once active (0.2/month vs. 0.62/month, p=0.018). Of active sites, 40 (83%) had research support personnel and 8 (17%) sites did not. Sites with research personnel were able to reach ‘enrolment ready’ status significantly faster than sites without research support (19.6 vs. 30.7 months, p=0.032). However, there was no significant difference in recruitment rate per month once the sites began enrolling (0.28/month vs. 0.2/month, p=0.63). Trial sites that took longer than 1 year to recruit their first patient had 3x lower average recruitment rate compared to sites that were able to recruit their first patient within a year of being enrolment ready.

The PARITY trial is the first multicentre RCT in orthopaedic oncology. The PARITY investigators were able to increase the recruitment levels throughout the trial and generally avoid trial fatigue. This was a North American based trial which may explain the longer start up times internationally given the different regulatory bodies associated with drug-related trials. However, international sites should be considered critical as they were able to recruit significantly more patients per month once active. The absence of research support personnel should not preclude a site from inclusion. These sites took longer to setup but had no difference in monthly recruitment once active. This study will create a framework for identifying and targeting high yield sites for future randomized control trials within orthopaedic oncology to maximum recruitment and resource allocation. Data quality is another consideration that will be addressed in future analyses of the PARITY trial.