In 2008 and 2010, AOSSM held NIH-supported conferences that focused on post-traumatic osteoarthritis. One outgrowth of those meetings is a potential initiative by AOSSM to conduct an Early ARthritis THerapies (EARTH) multi-center clinical study initiative involving human subjects without substantial joint degeneration but who are at risk for rapid progression of OA due to joint injury. The goal of EARTH would be to evaluate acute intervention strategies (the specific strategies are currently under consideration) following ACL tears that aim to delay or prevent the onset of post-traumatic osteoarthritis. The underlying hypotheses are that joint injury initiates a series of events resulting in more rapid joint degeneration culminating in early disabling OA, and that early intervention prior to the development of irreversible changes may modify the disease course.
An important initial step before launching such a project is to establish the feasibility of obtaining sufficient numbers of patients who present to orthopaedic surgeons within the hypothesized window during which chondroprotective interventions are most likely to be effective, i.e., within one week of injury. We wanted to assess your interest in participating in this feasibility study which has been approved by the AOSSM Board of Directors. Participation would involve recording some very basic information about all patients that you see for an initial ACL injury within a three month period. The information to be recorded would be date of ACL injury, date of initial visit, date of surgery (if operative case), concomitant injuries to index knee, prior injuries and surgeries to knee, and patient age, gender, height, and weight. This study would thus evaluate the number of patients that are seen within one week of injury and would help characterize these patients. This will also help us identify sites and surgeons who might be willing to participate in a future Society-organized clinical trial involving chondroprotective intervention in acute ACL-injured patients.
Data collection for the feasibility study will begin this August. In the meantime, we will be developing the infrastructure for the study which will include a web-based data entry system (a paper version will also be available). We anticipate that the study will be exempt from IRB review at many institutions but we will provide support for any site that does require IRB review.
If you are willing to participate in the feasibility study or if you would like additional information, please contact Kevin M. Boyer, MPH
, AOSSM Director of Research.