AIMS:This study reviews the past 30 years of research from the Canadian Orthopedic Trauma Society (COTS), to identify predictive factors that delay or accelerate the course of randomized controlled trials in orthopaedic trauma.METHODS:We conducted a methodological review of all papers published through the Canadian Orthopaedic Trauma Society or its affiliates. Data abstracted included: year of publication; journal of publication; study type; number of study sites; sample size; and achievement of sample size goals. Information about the study timelines was also collected, including: the date of study proposal to COTS; date recruitment began; date recruitment ended; and date of publication.RESULTS:In total, 22 studies have been published through the COTS working group, 13 of which are randomized controlled trials (RCTs). In total, 1,423 individual patients have been involved in COTS studies, a mean of 110 patients per trial (22 to 424). Each study was conducted across a mean of approximately six centres (1 to 11) and took nearly ten years (mean 119.9 months (59 to 188)) from presentation of concept to publication. The mean length of enrolment was 63 months (26 to 113) and the mean time from cessation of enrolment to publication 51 months (19 to 78). Regardless of sample size, the only factor associated with a decreased length of enrolment was a higher number of clinical sites (p = 0.041). Neither study sample size nor length of enrolment were associated with total time to publication.CONCLUSION:Over the last three decades, COTS has developed a multinational strategy to produce high-quality evidence in the field of orthopaedic trauma through 13 multicentre RCTs. Future efficiencies can be realized by recruitment of more clinical sites, improving connectivity between the sites, and the promotion of national streamlined ethics processes. Cite this article: Bone Joint J 2021;103-B(5):898-901.
Objectives:The purpose of this clinical study is to determine whether the rate of fracture healing and fracture union, repaired with a locked device, will be as good as or better than standard nonlocking bicortical fixation in distal femoral fractures.Design:Institutional review board-approved, multicenter prospective randomized controlled trial.Setting:Seven level 1 trauma centers across Canada.Patients:Fifty-two patients with distal femoral fractures (AO/OTA 33A1 to 33C2) were enrolled in the randomized trial. Twelve AO/OTA 33C3 fractures were excluded from the randomized trial but followed up as a nonrandomized cohort.Intervention:Patients were treated through a standardized minimally invasive approach. Fractures were randomized 1:1 to treatment with the locked Less Invasive Stabilization System (LISS; Synthes, Paoli, PA) or the dynamic condylar screw (DCS). The nonrandomized cohort was treated at the surgeon's discretion.Main Outcome Measurements:Primary outcomes were time to radiological union and number of delayed/nonunions at 12 months. Secondary outcomes were postoperative function and complications.Results:Fifty-two patients were randomized including 34 women and 18 men. The mean age was 59 years. Twenty-eight patients were treated with the LISS and 24 with the DCS. There was no statistically significant difference between the LISS and the DCS in terms of the number of fractures healed, time to union, or functional scores. Complications and revisions were more common in the LISS group. There were 7 reoperations in the LISS group and one in the DCS group. Only 52% of the LISS group healed without intervention by 12 months compared with 91% in the DCS group.Conclusions:There was no advantage to the locking plate design in the management of distal femoral fractures in this study. The higher cost of the locking plates, challenges in technique, and lack of superiority have led the authors to discontinue the use of this lateral unicortical locking device in favor of other devices that allow locked or nonlocked bicortical fixation, articular compression, and bridging of the comminuted fracture segments. The cost-effective treatment for a subgroup or periarticular fractures may be a fixed-angle nonlocked device in patients with reasonable bone quality.Level of Evidence:Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
The Canadian Orthopaedic Trauma Society was started in an endeavour to answer the difficult problem of obtaining enough patients to perform top-quality research into fractures. By maintaining a high standard, including randomised study design, inclusivity, open discussion among surgeons and excellent long-term follow-up, this group has become a leader in the orthopaedic research community. This annotation describes the short history, important components and spirit necessary to build a research community or team which will function well despite the difficult research environment facing individual surgeons.
To assess fragment micromotion in three fracture fixation constructs 18 composite femur models were sectioned to create AO-C3 fractures and fixed using the Less Invasive Stabilization System (LISS), Dynamic Condylar Screw (DCS), or the Condylar Buttress Plate (CBP). Tantalum beads were attached to each fracture fragment. The constructs were tested for permanent deformation after cyclical loading (amplitude = 242.2N) and elastic deformation during static loading with 490.5N. Radiographs were taken before loading and then after unloading to determine permanent deformation or during loading to determine elastic deformation. We used RSA to quantify the six degrees of freedom interfragmentary maximum total motion, strain, and stress. For maximum total motion the CBP had more permanent deformation and two failures, whereas the LISS underwent the greatest elastic deformation. LISS and CBP had the highest strain conditions in the fracture gap and LISS had the greatest stress movements between fragments, all of which exceeded the upper limits for bone healing. LISS and CBP may not be indicated for comminuted fractures due to the high degree of flexibility of the LISS, resulting in high stress and strain conditions and susceptibility to catastrophic failure and high strain conditions with the CBP.
Objectives: To compare the compressive strength of a bone substitute material (α-BSM™) to cancellous bone when used to fill a defect void in a cadaver model of a Schatzker II split depression fracture of the lateral tibial plateau. Design: Randomized, paired design. Setting: Biomedical engineering laboratory. Patients: Twenty-six human tibias were harvested from 13 cadavers. Three pairs of tibia fractured during preparation and were excluded. The remaining 10 matched pairs were randomized to fixation by using the bone substitute material or cancellous bone. Intervention: A split depression fracture of the lateral tibial plateau was created in each tibia by using reproducible methods. This fracture was stabilized with a stainless steel L-plate and screws and either α-BSM™ or cancellous bone to fill the defect void. Main Outcome Measurements: Stiffness of the elevated fragment in compression, total depression of the joint at 1000 N. Results: The α-BSM™ bone substitute displayed significantly greater stiffness than cancellous bone constructs in Schatzker II split depression fractures of the lateral tibial plateau (P < 0.0001). Plateau defects displaced significantly less at 1000N when using α-BSM™ in comparison to cancellous bone (P < 0.0001). Conclusions: In this cadaveric study, α-BSM™ is an effective bone substitute compared with cancellous bone graft for stabilizing split depression fractures of the lateral tibial plateau.
Aerial photographic surveys were conducted near Point Barrow, Alaska, from 12 April to 6 June in 2003, from 18 April to 7 June in 2004, from 6 to 9 September 2005, and 1 to 6 September 2006, and in the Bering Sea, Alaska, from 9 April to 2 May 2005. The 2003 survey was the most complete photographic coverage of the spring migration past Barrow of any survey to date, and the 2004 survey was also thorough except that poor weather resulted in poor coverage of the mother/calf migration late in the season. Approximately 1,157, 1,443 105, 81, and 454 photographs containing 1,606, 1,975, 114, 173 and 967 images were obtained in the respective seasons. The number of different marked whales with acceptable quality photographs to recognise between-year matches was 179 in 2003, 275 in 2004 and 71 in spring 2005. Within-year and between-year matching has been completed for the 2003-2005 spring photographs, and the databases are nearing completion. Eleven whales were matched between the 2003 and 2004 spring migrations, three whales were matched between 2003 and spring 2005, one was matched between spring 2004 and September 2005, and no matches were found between spring 2003 and September 2005. The photographs from these studies will permit calculation of a population estimate required for the AWMP management procedure and comparison with the estimate from ice- based counts in 2001 (George et al., 2004) and better precision in the calculation of bowhead whale life- history parameters. Stock structure analysis will be applied to resighting rates of bowheads photographed in April 2005 in the Bering Sea (early in the spring migration), through the spring migration near Barrow, during September near Barrow (which is prior to the main fall migration out of the Beaufort Sea), and in late summer in the Beaufort Sea (the primary feeding area).