The Canadian Orthopedic Trauma Society (COTS): Lessons Learned Over 30 years of World Class Level I Orthopedic Trauma Studies

This thesis describes the successful establishment of the Canadian Orthopaedic Trauma Society (COTS) and their highly regarded model for orthopaedic research. The lessons learned over the last 30 years are at the center, aiming to help other trauma societies in their research focus and to improve the quality of randomized controlled trials. Significant papers that were published by Prof. Ross Leighton under his leadership of the COTS are used in this thesis to underwrite the “lessons learnt” over the many years.
The first COTS prospective randomized controlled multicenter trial compared operative vs non-operative management of calcaneal fractures. The paper concluded that there was no significant difference in the outcome, however, when removing the patients that received Workers Compensation, the outcomes were significantly better in the surgically treated patients. Although the size of this difficult study may never be repeated for this injury, it demonstrates how a well-designed study with multicenter support can be done and that collaboration and combined efforts can lead to a paper cited over 1100 times to date. It formed the starting point for all subsequent COTS randomized trials and many lessons were learnt to pave the road to the future.
Subsequent prospective randomized controlled trials provided the world with knowledge comparing reamed vs unreamed femoral nailing, pointing out the frailty of small diameter nails and the extreme frailty of screws with a diameter of less than 5 mm. The results of this paper inspired the famous SPRINT trail which confirmed these findings.
Biomechanical research focusing on bone substitutes followed, which demonstrated the effect of studies building on each other. The initial study suggests bone substitutes might not only be as good but better than bone graft under a load. The subsequent landmark paper concluded that ceramic bone substitutes were better and more predictable than autogenous bone graft. Building on that knowledge, a well-performed meta-analysis followed, evaluating prospective randomized multicenter studies of that era that utilized calcium phosphate, concluding that calcium phosphate reduced the risk of subsidence and allowed for similar bone healing. It was apparent that a good meta-analysis can lead to a good research question, which can lead to a good randomized controlled trial. Sometimes a pilot study is required before proceeding. A pilot/feasibility study on Calcium Sulphate supports that. These smaller studies can improve the research question for the next clinical prospective study.
The ultimate power of a well-done multicentre prospective trial is demonstrated by providing compelling evidence that mid shaft clavicle fractures with 2 cm of shortening and 100% displacement were best treated with open reduction and internal fixation. This COTS paper has been cited thousands of times and has changed the clinical decision-making around the world.
A clinical study indicated that tightropes were as good if not better than 2 screws when treating an unstable syndesmosis. It taught the COTS that an industry-driven study can be done with minimal bias by obtaining an external grant. The study was completed and published within 2 years and has been cited thousands of times.
Chapter 11 is an invited paper by the JBJS featuring the history of the COTS group and highlights the pathway to the successful multicenter randomized prospective trials. Finally, a future publication of the COTS indicating that the group is not resting on its laurels but continues to submit and publish work that is novel and could change management. Continuous compartment pressure monitoring with a micro electric mechanical system (MEMS) type of transducer will undoubtly become the standard of care.

In conclusion, this thesis describes the ins and outs of the successful establishment of the Canadian Orthopaedic Trauma Society (COTS) and their highly regarded model for orthopaedic research. It illustrates the ability of a cohesive group to produce excellent randomized controlled trials and not only serves as an example for others but sets the standards.