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

Femoroacetabular impingement (FAI) is a condition of the hip where there is a mismatch of the femoral head and hip acetabulum. This mismatch creates abnormal contact between the bones and causes hip pain which can lead to damage, and eventually osteoarthritis of the hip. The diagnosis and treatment of FAI has become one of the most popular clinical scenarios in orthopaedic surgery, with hip arthroscopy procedures increasing exponentially over the past five years. Surgical intervention usually involves correcting the existing deformities by reshaping the ball and socket (“osteoplasty” or “rim trimming”) so that they fit together more easily while repairing any other existing soft tissue damage in the hip joint (e.g. labral repair). Although correction of the misshaped bony anatomy and associated intra-articular soft tissue damage of the hip is thought to appease impingement and improve pain and function, the current evidence is based on small, observational, and low quality studies. A lack of definitive evidence regarding the efficacy of osteochondroplasty in treating FAI fueled the design and execution of the FIRST randomized controlled trial (RCT). FIRST evaluated the impact of surgical correction of the hip impingement morphology with arthroscopic osteochondroplasty versus arthroscopic lavage on pain, function, and quality of life in adults aged 18–50 years diagnosed with non-arthritic FAI at one year. FIRST was a large definitive RCT (NCT01623843) enrolling patients with FAI requiring surgical intervention across 11 international clinical sites. Participants were randomized to either arthroscopic osteochondroplasty (shaving of bone) or lavage (washing the joint of painful inflammation debris). The primary outcome was patient-reported pain within one year of the initial surgery measured using the Visual Analogue Scale (VAS). Secondary outcomes included function, health utility, and health-related quality of life using several general and hip-centric health questionnaires. An independent, blinded adjudication committee evaluated the quality of surgery, re-operations, and other patient complications. Patients and data analysts were blinded to the treatment groups. Two-hundred and twenty participants were enrolled into the FIRST trial over a six-year period (pilot phase: N=50, from 2012–2013 and definitive phase: N=170, from 2015–2018) at 11 clinical sites in Canada, Finland, and Denmark. The FIRST results will be released at the ISAKOS annual meeting as follows. The absolute difference in rate of pain reduction between groups was XX (95% CI: YY-YY, p=X). The mean differences of the Short-Form 12 (SF-12, MCS and PCS), Hip Outcome Score (HOS), International Hip Outcome Tool (iHOT-12), and EuroQol 5-Dimensions (EQ-5D) between groups are XX (95% CI: YY-YY, p=X)…, respectively. Reoperations occurred in XX of 220 (X%) patients over the one-year follow up period (OR:XX, 95% CI: YY-YY, p=X) and the patients treated with arthroscopic osteochondroplasty conferred the following risk of reoperation within one-year compared to arthroscopic lavage (RR:XX, 95% CI: YY-YY, p=X). This RCT represents major international efforts to definitively identify the optimal treatment strategy for FAI. The results of this trial will change practice, being used to prevent chronic hip pain and loss of function caused by hip osteoarthritis

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

Background. Digital injuries are among the most common presentations to the emergency department. In order to sufficiently examine and manage these injuries, adequate, prompt, and predictable anaesthesia is essential. In this trial, we aim to primarily compare the degree of pain and anaesthesia onset time between the two-injection dorsal block technique (TD) and the single-injection volar subcutaneous block technique (SV). Further, we describe the temporal and anatomical effects of both techniques for an accurate delineation of the anesthetized regions. Methods. A single-centre prospective randomized controlled trial involving patients presenting with isolated wounds to the fingers requiring primary repair under local anaesthesia. Patients were randomized to either the SV or TD blocks. The primary outcome was procedure-related pain (Numerical Rating Scale). Further, we assessed the extent of anaesthesia along with the anaesthesia onset time. Results. A total of 100 patients were included in the final analysis, 50 on each arm of the study. The median pain score during injection was significantly higher in patients who received TD block than patients who received SV block (median [interquartile range] = 4 [2.25, 5] vs. 3 [2, 4], respectively, P = 0.006). However, anaesthesia onset time was not statistically different among the groups (P = 0.39). The extent of anaesthesia was more predictable in the dorsal block compared to the volar block. Conclusion. The single-injection volar subcutaneous blocks are less painful with a similar anaesthesia onset time. Injuries presenting in the proximal dorsal region may benefit from the two-injection dorsal blocks, given the anatomical differences and timely anaesthesia of the region

Thumb carpometacarpal joint (CMCJ) arthritis is a common and debilitating condition. The mainstay of surgical management is Trapeziectomy. Concerns about possible functional implications of collapse of the metacarpal into the arthroplasty space as well as the potential for scaphometacarpal led to the development of techniques to try and prevent this. The purpose of this study was to investigate if there were any significant differences in the long-term outcomes of patients who participated in a randomized trial of trapeziectomy alone compared with trapeziectomy with ligament reconstruction and tendon interposition (LRTI). Sixty-five patients participated in our original trial, the 1 year findings of which were published in 2007. These patients were invited for a follow-up visit at a mean of 17 years (range 15–20) postoperatively. Twenty-eight patients attended, who had 34 operations, 14 trapeziectomy alone and 20 with LRTI. Patients were asked to complete a visual analogue scale (VAS) for satisfaction with the outcome of their procedure, rated on a scale from 0 (most dissatisfied) to 100 (most satisfied). They also completed the short version of the Disabilities of the Arm, Shoulder and Hand Score (QuickDASH) at their appointment. They underwent a functional assessment with a hand therapist and had a radiograph of the thumb. There were no statistically significant differences between the two groups in terms of satisfaction with surgery or functional outcomes, with most measurements showing minimal or no differences in means between the two groups. There was no difference in the space between the metacarpal and scaphoid on radiograph. Radial abduction was the only parameter that was significantly greater in the patients with simple trapeziectomy (median 79°) compared with trapeziectomy with LRTI (median 71°) (p = 0.04). Even at 17 years there is no significant benefit of LRTI over trapeziectomy alone for thumb carpometacarpal joint osteoarthritis

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

Objective. Carpal tunnel release surgery is a commonly performed procedure for alleviating symptoms of median nerve compression and restoring hand function. With pressure on theatre time these procedures are now commonly performed in a step-down out-patient facility under local anaesthetic. The choice of suture for skin closure in this procedure can impact the quality of wound healing, patient outcomes and the follow-up required however the question of the best type of suture remains unanswered. The purpose of this study was to compare the outcomes of absorbable and non-absorbable sutures using a randomised control trial design. Methods. Eighty patients diagnosed with bilateral carpal tunnel syndrome were enrolled and underwent outpatient carpal tunnel release surgery under local anaesthetic in a staged fashion. Random number generation was used to assign each hand to receive interrupted nylon or Vicryl Rapide sutures. Pre-operative data collection included patient demographics, ASA, inflammatory conditions, smoking status as well as a Boston Carpal Tunnel Questionnaire (BCTQ) for each hand. Patients were followed up at 2 and 6 weeks after each operation and the BCTQ was repeated along with the Patient and Observer Scar Assessment Scale and the VAS score for wound discomfort. This study has approval from the DHB ethics committee, Local Iwi, HDC and ANZ Clinical Trials:ACTRN12623000100695. Results. Statistical analysis assessed patient preference and the scores between the groups. Multi-variate analysis was performed to assess the factors that may be contributing to patient choice. Conclusion. Insights into patient preference and clinical outcomes associated with absorbable sutures and non-absorbable sutures in the setting of out-patient surgery are discussed

Our primary objective was to compare healing rates in patients undergoing arthroscopic rotator cuff repair for degenerative tears, with and without bone channeling. Our secondary objectives were to compare disease-specific quality of life and patient reported outcomes as measured by the Western Ontario Rotator Cuff Index (WORC), American Shoulder and Elbow Surgeons (ASES) score and Constant score between groups. Patients undergoing arthroscopic rotator cuff repair at three sites were randomized to receive either bone channeling augmentation or standard repair. Healing rates were determined by ultrasound at 6 and 24 months post operatively. WORC, ASES, and Constant scores were compared between groups at baseline and at 3, 6, 12 and 24 months post operatively. One hundred sixty-eight patients were recruited and randomized between 2013 to 2018. Statistically significant improvements occurred in both groups from pre-operative to all time points in all clinical outcome scores (p < 0 .0001). Intention to treat analysis revealed no statistical differences in healing rates between the two interventions at 24 months post-operative. No differences were observed in WORC, ASES or Constant scores at any time-point. This trial did not demonstrate superiority of intra-operative bone channeling in rotator cuff repair surgery at 24 months post-operative. Healing rates and patient-reported function and quality of life measures were similar between groups

Novel immersive virtual reality (IVR) technologies are revolutionizing medical education. Virtual anatomy education using head-mounted displays allows users to interact with virtual anatomical objects, move within the virtual rooms, and interact with other virtual users. While IVR has been shown to be more effective than textbook learning and 3D computer models presented in 2D screens, the effectiveness of IVR compared to cadaveric models in anatomy education is currently unknown. In this study, we aim to compare the effectiveness of IVR with direct cadaveric bone models in teaching upper and lower limb anatomy for first-year medical students. A randomized, double-blind crossover non-inferiority trial was conducted. Participants were first-year medical students from a single University. Exclusion criteria included students who undertook prior undergraduate or graduate degrees in anatomy. In the first stage of the study, students were randomized in a 1:1 ratio to IVR or cadaveric bone groups studying upper limb skeletal anatomy. All students were then crossed over and used cadaveric bone or IVR to study lower limb skeletal anatomy. All students in both groups completed a pre-and post-intervention knowledge test. The educational content was based on the University of Toronto Medical Anatomy Curriculum. The Oculus Quest 2 Headsets (Meta Technologies) and PrecisionOS Anatomy application (PrecisionOS Technology) were utilized for the virtual reality component. The primary endpoint of the study was student performance on the pre-and post-intervention knowledge tests. We hypothesized that student performance in the IVR groups would be comparable to the cadaveric bone group. 50 first-year medical students met inclusion criteria and were computer randomized (1:1 ratio) to IVR and cadaveric bone group for upper limb skeletal anatomy education. Forty-six students attended the study, 21 completed the upper limb modules, and 19 completed the lower limb modules. Among all students, average score on the pre-intervention knowledge test was 14.6% (Standard Deviation (SD)=18.2%) and 25.0% (SD=17%) for upper and lower limbs, respectively. Percentage increase in students’ scores between pre-and post-intervention knowledge test, in the upper limb for IVR, was 15 % and 16.7% for cadaveric bones (p = 0. 2861), and for the lower limb score increase was 22.6% in the IVR and 22.5% in the cadaveric bone group (p = 0.9356). In this non-inferiority crossover randomized controlled trial, we found no significant difference between student performance in knowledge tests after using IVR or cadaveric bones. Immersive virtual reality and cadaveric bones were equally effective in skeletal anatomy education. Going forward, with advances in VR technologies and anatomy applications, we can expect to see further improvements in the effectiveness of these technologies in anatomy and surgical education. These findings have implications for medical schools having challenges in acquiring cadavers and cadaveric parts

Novel immersive virtual reality (IVR) technologies are revolutionizing medical education. Virtual anatomy education using head-mounted displays allows users to interact with virtual anatomical objects, move within the virtual rooms, and interact with other virtual users. While IVR has been shown to be more effective than textbook learning and 3D computer models presented in 2D screens, the effectiveness of IVR compared to cadaveric models in anatomy education is currently unknown. In this study, we aim to compare the effectiveness of IVR with direct cadaveric bone models in teaching upper and lower limb anatomy for first-year medical students. A randomized, double-blind crossover non-inferiority trial was conducted. Participants were first-year medical students from a single University. Exclusion criteria included students who undertook prior undergraduate or graduate degrees in anatomy. In the first stage of the study, students were randomized in a 1:1 ratio to IVR or cadaveric bone groups studying upper limb skeletal anatomy. All students were then crossed over and used cadaveric bone or IVR to study lower limb skeletal anatomy. All students in both groups completed a pre-and post-intervention knowledge test. The educational content was based on the University of Toronto Medical Anatomy Curriculum. The Oculus Quest 2 Headsets (Meta Technologies) and PrecisionOS Anatomy application (PrecisionOS Technology) were utilized for the virtual reality component. The primary endpoint of the study was student performance on the pre-and post-intervention knowledge tests. We hypothesized that student performance in the IVR groups would be comparable to the cadaveric bone group. 50 first-year medical students met inclusion criteria and were computer randomized (1:1 ratio) to IVR and cadaveric bone group for upper limb skeletal anatomy education. Forty-six students attended the study, 21 completed the upper limb modules, and 19 completed the lower limb modules. Among all students, average score on the pre-intervention knowledge test was 14.6% (Standard Deviation (SD)=18.2%) and 25.0% (SD=17%) for upper and lower limbs, respectively. Percentage increase in students’ scores between pre-and post-intervention knowledge test, in the upper limb for IVR, was 15 % and 16.7% for cadaveric bones (p = 0. 2861), and for the lower limb score increase was 22.6% in the IVR and 22.5% in the cadaveric bone group (p = 0.9356). In this non-inferiority crossover randomized controlled trial, we found no significant difference between student performance in knowledge tests after using IVR or cadaveric bones. Immersive virtual reality and cadaveric bones were equally effective in skeletal anatomy education. Going forward, with advances in VR technologies and anatomy applications, we can expect to see further improvements in the effectiveness of these technologies in anatomy and surgical education. These findings have implications for medical schools having challenges in acquiring cadavers and cadaveric parts

Introduction. Comparative studies examining Fixed-Bearing (FB) and Mobile-Bearing (MB) Total Ankle Replacement (TAR) designs have demonstrated similar results and successful long-term outcomes for both. To date there has been no study directly comparing FB and MB designs of the same prosthesis. We present the first prospective randomised trial comparing patient satisfaction, functional outcomes and radiographic results of the Salto Talaris Fixed-Bearing and the Salto Mobile-Bearing Total Ankle Replacement in the treatment of end-stage ankle arthritis. Methods. A total of 108 adult patients with end-stage ankle arthritis were enrolled in the study between November 2014 and October 2021 with similar demographic comparison. Prospective patient-reported outcomes and standardised weightbearing ankle radiographs were performed preoperatively, at 6 weeks, 6 months and 12 months post-operatively, followed by yearly intervals. All surgeries were performed by a single non-design orthopaedic foot and ankle specialist with experience in over 200 Salto and Salto Talaris TAR prior to the study. Radiographs were examined independently by two clinicians. Complete patient data and radiographs were available for 103 patients with an average follow up of 2 years. Results. Both groups demonstrated statistically significant improvement from preoperative evaluation to most recent follow up with no statistically significant difference between the two groups in all outcome measures. Radiographic incidence of subchondral cyst formation was 8.9% and 38.2% for FB and MB, respectively. Talar subsidence occurred in 2.2% and 5.5% of FB and MB, respectively. Discussion. Our study demonstrates a higher than previously reported rate of cyst formation in the MB TAR and comparatively higher talar subsidence in the MB TAR vs FB however this did not correlate with clinical outcome measures which were favourable for both groups. Conclusion. Fixed-Bearing and Mobile-Bearing Total Ankle Replacement demonstrate comparable favourable

The aim of this study was to investigate surgeons’ reported change of treatment preference in response to the results and conclusion from a randomized controlled trial (RCT) and to study patterns of change between subspecialties and nationalities. Two questionnaires were developed through the Delphi process for this cross-sectional survey of surgical preference. The first questionnaire was sent out before the publication of a RCT and the second questionnaire was sent out after publication. The RCT investigated repair or non-repair of the pronator quadratus (PQ) muscle during volar locked plating of distal radial fractures (DRFs). Overall, 380 orthopaedic surgeons were invited to participate in the first questionnaire, of whom 115 replied. One hundred surgeons were invited to participate in the second questionnaire. The primary outcome was the proportion of surgeons for whom a treatment change was warranted, who then reported a change of treatment preference following the RCT. Secondary outcomes included the reasons for repair or non-repair, reasons for and against following the RCT results, and difference of preferred treatment of the PQ muscle between surgeons of different nationalities, qualifications, years of training, and number of procedures performed per year. Of the 100 surgeons invited for the second questionnaire, 74 replied. For the primary outcome, 6 of 32 surgeons (19%), who usually repaired the PQ muscle and therefore a change of treatment preference was warranted, reported a change of treatment preference based on the RCT publication. Of the secondary outcomes, restoring anatomy was the most common response for repairing the PQ muscle. The majority of the orthopaedic surgeons, where a change of treatment preference was warranted based on the results and conclusion of a RCT, did not report willingness to change their treatment preference

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

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

Aim. In 10% of the presumed aseptic hip or knee revisions, a low-grade infection is unexpectedly diagnosed based on the tissue samples taken during revision. Extended antimicrobial prophylaxis can possibly reduce the failure rate in cases of unexpected PJI, because the prophylaxis can be considered as early empiric treatment. In this randomized controlled study we analysed whether extended antimicrobial prophylaxis compared to a single dose is beneficial to improve the outcome of treatment in unexpected PJI in revision arthroplasty. Method. This study was nested in a randomized clinical trial comparing single-dose cefazolin with prolonged prophylaxis (15 doses of cefazolin over 5 days) for revision arthroplasty of the hip or knee. For this analysis, patients were included if an unsuspected PJI (defined as ≥2 positive intraoperative tissue samples with the same microorganism) was diagnosed. PJI treatment consisted of 12 weeks of a rifampicin-based regimen in Staphylococcal PJI, without removal of the prosthesis. We examined Infection characteristics and success of treatment after one year, defined as the absence of signs or treatment for PJI during follow-up. Results. After randomization of 662 patients, 68 unexpected PJI were diagnosed. In 5 cases no antimicrobial treatment was started. The success rate after one year follow-up for those who received PJI treatment was 96% (28/29) in the single dose group and 91% (31/34) in the extended prophylaxis group (p=1.00). The most frequently identified pathogens in unexpected PJI were Cutibacterium acnes (n=50) and Staphylococcus epidermidis (n=14). The causatives were susceptible for the cefazolin prophylaxis in 61 of the 63 cases. The interval between the stopped prophylaxis and the re-start of antimicrobial treatment was on average 10 days (SD 4) for the single dose and 5 days (SD 4) for the extended group. The mean duration of antimicrobial treatment was 83 days (SD 12) and did not differ between both groups (p=0.16). Conclusions. This is the first randomized controlled trial in which extended prophylaxis showed no benefit on the prosthesis survival for patients with an unexpected PJI after assumed aseptic revision of the hip or knee prosthesis. The results imply that extended prophylaxis should not be given as part of early empiric therapy

Previously, we conducted a multi-center, double-blinded randomized controlled trial comparing arthroscopic Bankart repair with and without remplissage. The end point for the randomized controlled trial was two years post-operative, providing support for the benefits of remplissage in the short term in reducing recurrent instability. The aim of this study was to compare the medium term (3 to 9 years) outcomes of patients previously randomized to have undergone isolated Bankart repair (NO REMP) or Bankart repair with remplissage (REMP) for the management of recurrent anterior glenohumeral instability. The rate of recurrent instability and instances of re-operation were examined. The original study was a double-blinded, randomized clinical trial with two 1:1 parallel groups with recruitment undertaken between 2011 and 2017. For this medium-term study, participants were reached for a telephone follow-up in 2020 and asked a series of standardized questions regarding ensuing instances of subluxation, dislocation or reoperation that had occurred on their shoulder for which they were randomized. Descriptive statistics were generated for all variables. “Failure” was defined as occurrence of a dislocation. “Recurrent instability” was defined as the participant reporting a dislocation or two or more occurences of subluxation greater than one year post-operative. All analyses were undertaken based on intention-to-treat whereby their data was analyzed based on the group to which they were originally allocated. One-hundred and eight participants were randomized of which 50 in the NO REMP group and 52 in the REMP group were included in the analyses in the original study. The mean number of months from surgery to final follow-up was 49.3 for the NO REMP group and 53.8 for the REMP group. The rates of re-dislocation or failure were 8% (4/52) in the REMP group at an average of 23.8 months post-operative versus 22% (11/50) in the NO REMP at an average of 16.5 months post-operative. The rates of recurrent instability were 10% (5/52) in the REMP group at an average of 24 months post-operative versus 30% (15/50) in the NO REMP group at an average of 19.5 months post-operative. Survival curves were significantly different favouring REMP in both scenarios. Arthroscopic Bankart repair combined with remplissage is an effective procedure in the treatment of patients with an engaging Hill-Sachs lesion and minimal glenoid bone loss (<15%). Patients can expect favourable rates of recurrent instability when compared with isolated Bankart repair at medium term follw-up

There is no consensus regarding the optimum frequency of ultrasound for monitoring the response to Pavlik harness (PH) treatment in developmental dysplasia of hip (DDH). The purpose of our study was to determine if a limited-frequency hip ultrasound (USS) assessment in children undergoing PH treatment for DDH had an adverse effect on treatment outcomes when compared to traditional comprehensive ultrasound monitoring. This study was a single-center non-inferiority randomized controlled trial. Children aged less than six months of age with dislocated, dislocatable and stable dysplastic hips undergoing a standardized treatment program with a PH were randomized, once stability had been achieved, to our current standard USS monitoring protocol (every clinic visit) or to a limited-frequency ultrasound protocol (USS only until hip stability and then end of treatment). Groups were compared based on alpha angle at the end of treatment, acetabular indices (AI) and IHDI grade on follow up radiographs at one-year post harness and complication rates. The premise was that if there were no differences in these outcomes, either protocol could be deemed safe and effective. One hundred patients were recruited to the study; after exclusions, 42 patients completed the standard protocol (SP) and 36 completed the limited protocol (LP). There was no significant difference between the mean age between both groups at follow up x-ray (SP: 17.8 months; LP: 16.6 months; p=0.26). There was no difference between the groups in mean alpha angle at the end of treatment (SP: 69°; LP: 68.1°: p=0.25). There was no significant difference in the mean right AI at follow up (SP: 23.1°; LP: 22.0°; p=0.26), nor on the left (SP:23.3°; LP 22.8°; p=0.59). All hips in both groups were IHDI grade 1 at follow up. The only complication was one femoral nerve palsy in the SP group. In addition, the LP group underwent a 60% reduction in USS use once stable. We found that once dysplastic or dislocated hips were reduced and stable on USS, a limited- frequency ultrasound protocol was not associated with an inferior complication or radiographic outcome profile compared to a standardized PH treatment pathway. Our study supports reducing the frequency of ultrasound assessment during PH treatment of hip dysplasia. Minimizing the need for expensive, time-consuming and in-person health care interventions is critical to reducing health care costs, improving patient experience and assists the move to remote care. Removing the need for USS assessment at every PH check will expand care to centers where USS is not routinely available and will facilitate the establishment of virtual care clinics where clinical examination may be performed remotely

Patients awaiting resolution of swelling and oedema prior to ankle surgery can represent a significant burden on hospital beds. Our study assessed whether external pneumatic intermittent compression (EPIC) can reduce delays to surgery. Our prospective randomised controlled trial (n= 20) compared outcomes of patients treated with EPIC vs control group managed with ice and elevation. Included were patients aged <18 years with isolated closed ankle fractures admitted for management of swelling prior to surgery. Excluded were open fractures, injuries to contralateral leg, diabetes, absent pulses, peripheral vascular disease, inability to consent, no requirement for admission. Eligible patients were randomised to active or control arms. All patients were managed initially with reduction and back slab application. Patients in active arm fitted with EPIC (Hydroven 3000) device over the back slab. Assessment by treating team determined the time at which patient is assessed ready for surgery. Patients in the treatment arm were assessed as ready for surgery sooner, (123 hrs vs 168hrs, T score = 1.925, P 0.035) and had a shorter time to surgery (167 hrs vs 216 hrs, T score = 1.748, P 0.047) Length of stay was reduced bud did not reach statistical significance. (259 hrs vs 269 hrs, T score 0.229, P 0.41). Our results showed a statistically and clinically significant reduction in time that patients were assessed ready for surgery and time to surgery in the treatment cohort. We conclude that although further data is needed to achieve an adequately powered study and assess the safety profile of the EPIC, incorporation of EPIC into routine clinical practice has the potential for significant cost savings

Cryocompression therapy is a non-invasive and non-pharmacological modality used in managing acute post-operative inflammation and pain. A prospective, randomised controlled trial (RCT) was undertaken to evaluate the effectiveness of a post-operative cryocompression protocol using the Game Ready™ (GR) device versus usual care on recovery following total knee arthroplasty (TKA). A single centre RCT was conducted with 70 TKAs (68 patients) randomised to a 2-week intervention period consisting of treatment with GR cryocompression (n=33, 33.3% males) or a usual care protocol of ice with static compression using tubigrip (n=35, 54.3% males). Knee range of movement (ROM) (flexion and extension), a visual analogue pain score (VAS) and limb circumference were documented at day 1, 2 and 14, as well as 6 and 12 weeks post-surgery. ROM was also recorded at day 90, while medication use and length of hospital stay were documented. Patient reported outcome measures (PROMs) including the KOOS and patient satisfaction questionnaire were employed. The GR group demonstrated 2.3° more (p=0.05) knee extension ROM overall, as well as 2. 8° more at day 1 (p=0.048), 3.8° at day 14 (p=0.007) and 5.4° at 3 months (p=0.017). There were no group differences (p>0.05) observed in pain (VAS), flexion ROM, limb circumference, opioid use or other PROMs. Across the full cohort, higher pain levels resulted in increased opioid intake (p=0.002), older patients used significantly less opioids (p<0.001) and males reported significantly less pain (VAS) than females (p=0.048). Using GR following TKA is a safe, non-invasive tool that can be used to aid in the post-operative recovery period. Patients using the GR cryocompression device gained significantly more extension ROM compared to the conventional ice with compression group, despite no other group differences

Hamstring grafts have been associated with reduced strength, donor site pain and muscle strains following Anterior Cruciate Ligament Reconstruction (ACLR). Traditional graft fixation methods required both semitendinosus and gracilis tendons to achieve a graft of sufficient length and diameter, but newer techniques allow for shorter, broad single tendon grafts. This study seeks to compare the outcomes between Single Tendon (ST) and Dual Tendon (DT) ACLR, given there is no prospective randomised controlled trial (RCT) in the literature comparing outcomes between these options. In this ongoing RCT: (ANZ Clinical Trials Registry ACTRN126200000927921) patients were recruited and randomised into either ST or DT groups. All anaesthetic and surgical techniques were uniform aside from graft technique and tibial fixation. 13 patients were excluded at surgery as their ST graft did not achieve a minimum 8mm diameter. 70 patients (34 ST, 36DT) have been assessed at 6 months, using PROMS including IKDC2000, Lysholm and Modified Cincinnati Knee, visual analog scale for pain frequency (VAS-F) and severity (VAS-S), dedicated donor site morbidity score, KT-1000 assessment, and isokinetic strength. Graft diameters were significantly lesser in the ST group compared to the DT group (8.44mm/9.11mm mean difference [MD],-0.67mm; P<0.001). There was a significant and moderate effect in lower donor site morbidity in the ST group compared to the DT group (effect size [ES], 0.649; P = .01). No differences between groups were observed for knee laxity in the ACLR limb (P=0.362) or any of the patient-reported outcome measures (P>0.05). Between-group differences were observed for hamstrings strength LSI favouring the ST group, though these were small-to-moderate and non-significant (ES, 0.351; P = .147). ST (versus DT) harvest results in significantly less donor site morbidity and this is the first prospective RCT to determine this. There were no differences between ST and DT hamstring ACLR were observed in PROMs, knee laxity and hamstring strength. Younger female patients tend to have inadequate single tendon size to produce a graft of sufficient diameter, and alternative techniques should be considered. Further endpoints include radiological analysis, longer term donor site morbidity, revision rates and return to sport and will continue to be presented in the future