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Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 49 - 49
1 Dec 2022
Khalik HA Wood T Tushinski D Gazendam A Petruccelli D Bali K
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Primary hip and knee joint replacements in Canada have been estimated to cost over $1.4 billion dollars annually, with revision surgery costing $177 million. The most common cause of revision arthroplasty surgery in Canada is infection. Periprosthetic joint infections (PJIs) are a devastating though preventable complication following arthroplasty. Though variably used, antibiotic laden bone cement (ALBC) has been demonstrated to decrease PJIs following primary total knee arthroplasty (TKA). Unfortunately, ALBC is costlier than regular bone cement (RBC). Therefore, the aim of this study was to determine if the routine use of ALBC in primary TKA surgery is a cost-effective practice from the perspective of the Canadian healthcare system.

A decision tree was constructed using a decision analysis software (TreeAge Software, Williamstown, Massachusetts) to a two-year time horizon comparing primary TKA with either ALBC or RBC from the perspective of a single-payer healthcare system. All costs were in 2020 Canadian dollars. Health utilities were in the form of quality adjusted life years (QALYs). Model inputs for cost were derived from regional and national databases. Health utilities and probability parameters were derived from the latest literature. One-way deterministic sensitivity analysis was performed on all model parameters. The primary outcome of this analysis was an incremental cost-effectiveness ratio (ICER) with a willingness-to-pay (WTP) threshold of $50,000 per QALY.

Primary TKA with ALBC (TKA-ALBC) was found to be more cost-effective compared to primary TKA with RBC (TKA-RBC). More specifically, TKA-ALBC dominated TKA-RBC as it was less costly on the long term ($11,160 vs. $11,118), while providing the same QALY (1.66). The ICER of this cost-utility analysis (CUA) was $-11,049.72 per QALY, much less than the WTP threshold of $50,000 per QALY. The model was sensitive to costs of ALBC-TKA as well as the probability of PJI following ALBC-TKA and RBC-TKA. ALBC ceased to be cost effective once the cost of ALBC was greater than $223.08 CAD per bag of cement.

The routine use of ALBC in primary TKA is a cost-effective practice in the context of the Canadian healthcare system as long as the cost of ALBC is maintained at a reasonable price and the published studies to-date keep supporting the efficacy of ALBC in decreasing PJI following primary TKA. Further, this analysis is very conservative, and ALBC is likely much more cost-effective than presented. This is due to this model's revision surgery cost parameter being based on the average cost of all revision TKA surgery in Canada, regardless of etiology. Considering many PJIs require two-stage revisions, the cost parameter used in this analysis for revision surgery is an underestimate of true cost. Ultimately, this is the first cost-effectiveness study evaluating this topic from the perspective of the Canadian healthcare system and can inform future national guidelines on the subject matter.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_13 | Pages 93 - 93
1 Dec 2022
Gazendam A Schneider P Busse J Giglio V Bhandari M Ghert M
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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.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 65 - 65
1 Dec 2022
Gazendam A Ayeni OR
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Orthopaedic surgeons prescribe more opioids than any other surgical speciality. Opioids remain the analgesic of choice following arthroscopic knee and shoulder surgery. There is growing evidence that opioid-sparing protocols may reduce postoperative opioid consumption while adequately addressing patients’ pain. However, there are a lack of prospective, comparative trials evaluating their effectiveness. The objective of the current randomized controlled trial (RCT) was to evaluate the efficacy of a multi-modal, opioid-sparing approach to postoperative pain management in patients undergoing arthroscopic shoulder and knee surgery.

The NO PAin trial is a pragmatic, definitive RCT (NCT04566250) enrolling 200 adult patients undergoing outpatient shoulder or knee arthroscopy. Patients are randomly assigned in a 1:1 ratio to an opioid-sparing group or standard of care. The opioid-sparing group receives a three-pronged prescription package consisting of 1) a non-opioid prescription: naproxen, acetaminophen and pantoprazole, 2) a limited opioid “rescue prescription” of hydromorphone, and 3) a patient education infographic. The control group is the current standard of care as per the treating surgeon, which consists of an opioid analgesic. The primary outcome of interest is oral morphine equivalent (OME) consumption up to 6 weeks postoperatively. The secondary outcomes are postoperative pain scores, patient satisfaction, quantity of OMEs prescribed and number of opioid refills. Patients are followed at both 2 and 6 weeks postoperatively. Data analysts and outcome assessors are blinded to the treatment groups.

As of December 1, 2021 we have enrolled 166 patients, reaching 83% of target enrolment. Based on the current recruitment rate, we anticipate that enrolment will be completed by the end of January 2022 with final follow-up and study close out completed by March of 2022. The final results will be released at the Canadian Orthopaedic Association Meeting in June 2022 and be presented as follows. The mean difference in OME consumption was XX (95%CI: YY-YY, p=X). The mean difference in OMEs prescribed was XX (95%CI: YY-YY, p=X). The mean difference in Visual Analogue Pain Scores (VAS) and patient satisfaction are XX (95%CI: YY-YY, p=X). The absolute difference in opioid refills was XX (95%CI: YY-YY, p=X).

The results of the current study will demonstrate whether an opioid sparing approach to postoperative outpatient pain management is effective at reducing opioid consumption while adequately addressing postoperative pain in patients undergoing outpatient shoulder and knee arthroscopy. This study is novel in the field of arthroscopic surgery, and its results will help to guide appropriate postoperative analgesic management following these widely performed procedures.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 36 - 36
1 Dec 2022
Gazendam A Tushinski D Patel M Bali K Petruccelli D Winemaker MJ de Beer J Gillies L Best K Fife J Wood T
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Same day home (SDH) discharge in total joint arthroplasty (TJA) has increased in popularity in recent years. The objective of this study was to evaluate the causes and predictors of failed discharges in planned SDH patients.

A consecutive cohort of patients who underwent total knee (TKA) or total hip arthroplasty (THA) that were scheduled for SDH discharge between April 1, 2019 to March 31, 2021 were retrospectively reviewed. Patient demographics, causes of failed discharge, perioperative variables, 30-day readmissions and 6-month reoperation rates were collected. Multivariate regression analysis was undertaken to identify independent predictors of failed discharge.

The cohort consisted of 527 consecutive patients. One hundred and one (19%) patients failed SDH discharge. The leading causes were postoperative hypotension (20%) and patients who were ineligible for the SDH pathway (19%). Two individual surgeons, later operative start time (OR 1.3, 95% CI, 1.15-1.55, p=0.001), ASA class IV (OR 3.4, 95% CI, 1.4-8.2; p=0.006) and undergoing a THA (OR 2.0, 95% CI, 1.2-3.1, p=0.004) were independent predictors of failed SDH discharge. No differences in age, BMI, gender, surgical approach or type of anesthetic were found (p>0.05). The 30-day readmission or 6-month reoperation were similar between groups (p>0.05).

Hypotension and inappropriate patient selection were the leading causes of failed SDH discharge. Significant variability existed between individual surgeons failed discharge rates. Patients undergoing a THA, classified as ASA IV or had a later operative start time were all more likely to fail SDH discharge.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 57 - 57
1 Dec 2022
Gazendam A Ekhtiari S Wood T Petruccelli D Tushinski D Winemaker MJ de Beer J
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The Accolade®TMZF is a taper-wedge cementless metaphyseal coated femoral stem widely utilized from 2002-2012. In recent years, there have been reports of early catastrophic failure of this implant. Establishing a deeper understanding of the rate and causes of revision in patients who developed aseptic failure in stems with documented concerns about high failure rates is critical. Understanding any potential patient or implant factors which are risk factors for failure is important to inform both clinicians and patients. We propose a study to establish the long-term survival of this stem and analyze patients who underwent aseptic revision to understand the causes and risk factors for failure.

A retrospective review was undertaken of all patients who received a primary total hip arthroplasty with an Accolade® TMZF stem at a high-volume arthroplasty center. The causes and timing of revision surgery were documented and cross referenced with the Canadian Institute of Health Information Discharge Abstract Database to minimize loss to follow-up. Survivorship analysis was performed with use of the Kaplan-Meier curves to determine the overall and aseptic survival rates at final follow-up. Patient and implant factors commonly associated with aseptic failure were extracted and Cox proportional hazards model was used.

A consecutive series of 2609 unilateral primary THA patients implanted with an Accolade®TMZF femoral hip stem were included. Mean time from primary surgery was 12.4 years (range 22 days to 19.5 years). Cumulative survival was 96.1% ± 0.2 at final follow-up. One hundred and seven patients underwent revision surgery with aseptic loosening of the femoral component was the most common cause of aseptic failure in this cohort (33/2609, 1.3%). Younger age and larger femoral head offset were independent risk factors for aseptic failure.

To our knowledge, this is the largest series representing the longest follow-up of this taper-wedge cementless femoral implant. Despite early concerns, the Accolade® TMZF stem has excellent survivorship in this cohort. Trunnionosis as a recognized cause for revision surgery was rare. Younger age and larger femoral head offset were independent risk factors for aseptic failure.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_13 | Pages 92 - 92
1 Dec 2022
Gazendam A Schneider P Busse J Bhandari M Ghert M
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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.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 51 - 51
1 Dec 2022
Gazendam A Bali K Tushinski D Petruccelli D Winemaker MJ de Beer J Wood T
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During total knee arthroplasty (TKA), a tourniquet is often used intraoperatively. There are proposed benefits of tourniquet use including shorter duration of surgery, improved surgical field visualization and increased cement penetration which may improve implant longevity. However, there are also cited side effects that include increased post-operative pain, slowed recovery, skin bruising, neurovascular injury and quadriceps weakness. Randomized controlled trials have demonstrated no differences in implant longevity, however they are limited by short follow-up and small sample sizes. The objective of the current study was to evaluate the rates of revision surgery among patients undergoing cemented TKA with or without an intraoperative tourniquet and to understand the causes and risk factors for failure.

A retrospective cohort study was undertaken of all patients who received a primary, cemented TKA at a high-volume arthroplasty centre from January 1999 to December 2010. Patients who underwent surgery without the use of a tourniquet and those who had a tourniquet inflated for the entirety of the case were included. The causes and timing of revision surgery were recorded and cross referenced with the Canadian Institute of Health Information Discharge Abstract Database to reduce the loss to follow-up. Survivorship analysis was performed with the use of Kaplan-Meier curves to determine overall survival rates at final follow-up. A Cox proportional hazards model was utilized to evaluate independent predictors of revision surgery.

Data from 3939 cases of primary cemented TKA were available for analysis. There were 2276 (58%) cases in which a tourniquet was used for the duration of the surgery and 1663 (42%) cases in which a tourniquet was not utilized. Mean time from the primary TKA was 14.7 years (range 0 days - 22.8 years) when censored by death or revision surgery. There were 150 recorded revisions in the entire cohort, with periprosthetic joint infection (n=50) and aseptic loosening (n=41) being the most common causes for revision. The cumulative survival at final follow-up for the tourniquetless group was 93.8% at final follow-up while the cumulative survival at final follow-up for the tourniquet group was 96.9% at final follow-up. Tourniquetless surgery was an independent predictor for all-cause revision with an HR of 1.53 (95% CI 1.1, 2.1, p=0.011). Younger age and male sex were also independent factors for all cause revision.

The results of the current study demonstrate higher all-cause revision rates with tourniquetless surgery in a large cohort of patients undergoing primary cemented TKA. The available literature consists of short-term trials and registry data, which have inherent limitations. Potential causes for increased revision rates in the tourniquetless group include reduced cement penetration, increased intraoperative blood loss and longer surgical. The results of the current study should be taken into consideration, alongside the known risks and benefits of tourniquet use, when considering intraoperative tourniquet use in cemented TKA.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_13 | Pages 71 - 71
1 Dec 2022
Gazendam A Ekhtiari S Ayeni OR
Full Access

Orthopaedic surgeons prescribe more opioids than any other surgical speciality. Opioids remain the analgesic of choice following arthroscopic knee and shoulder surgery. There is growing evidence that opioid-sparing protocols may reduce postoperative opioid consumption while adequately addressing patients’ pain. However, there are a lack of prospective, comparative trials evaluating their effectiveness. The objective of the current randomized controlled trial (RCT) was to evaluate the efficacy of a multi-modal, opioid-sparing approach to postoperative pain management in patients undergoing arthroscopic shoulder and knee surgery.

The NO PAin trial is a pragmatic, definitive RCT (NCT04566250) enrolling 200 adult patients undergoing outpatient shoulder or knee arthroscopy. Patients are randomly assigned in a 1:1 ratio to an opioid-sparing group or standard of care. The opioid-sparing group receives a three-pronged prescription package consisting of 1) a non-opioid prescription: naproxen, acetaminophen and pantoprazole, 2) a limited opioid “rescue prescription” of hydromorphone, and 3) a patient education infographic. The control group is the current standard of care as per the treating surgeon, which consists of an opioid analgesic. The primary outcome of interest is oral morphine equivalent (OME) consumption up to 6 weeks postoperatively. The secondary outcomes are postoperative pain scores, patient satisfaction, quantity of OMEs prescribed and number of opioid refills. Patients are followed at both 2 and 6 weeks postoperatively. Data analysts and outcome assessors are blinded to the treatment groups.

As of December 1, 2021 we have enrolled 166 patients, reaching 83% of target enrolment. Based on the current recruitment rate, we anticipate that enrolment will be completed by the end of January 2022 with final follow-up and study close out completed by March of 2022. The final results will be released at the Canadian Orthopaedic Association Meeting in June 2022 and be presented as follows. The mean difference in OME consumption was XX (95%CI: YY-YY, p=X). The mean difference in OMEs prescribed was XX (95%CI: YY-YY, p=X). The mean difference in Visual Analogue Pain Scores (VAS) and patient satisfaction are XX (95%CI: YY-YY, p=X). The absolute difference in opioid refills was XX (95%CI: YY-YY, p=X).

The results of the current study will demonstrate whether an opioid sparing approach to postoperative outpatient pain management is effective at reducing opioid consumption while adequately addressing postoperative pain in patients undergoing outpatient shoulder and knee arthroscopy. This study is novel in the field of arthroscopic surgery, and its results will help to guide appropriate postoperative analgesic management following these widely performed procedures.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_3 | Pages 72 - 72
1 Mar 2021
Gazendam A Bozzo A Schneider P Giglio V Wilson D Ghert M
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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.