TY - JOUR
T1 - Toward designing human intervention studies to prevent osteoarthritis after knee injury
T2 - A report from an interdisciplinary OARSI 2023 workshop
AU - Whittaker, Jackie L.
AU - Kalsoum, Raneem
AU - Bilzon, James
AU - Conaghan, Philip G.
AU - Crossley, Kay
AU - Dodge, George R.
AU - Getgood, Alan
AU - Li, Xiaojuan
AU - Losina, Elena
AU - Mason, Deborah J.
AU - Pietrosimone, Brian
AU - Risberg, May Arna
AU - Roemer, Frank
AU - Felson, David
AU - Culvenor, Adam G.
AU - Meuffels, Duncan
AU - Gerwin, Nicole
AU - Simon, Lee S.
AU - Lohmander, L. Stefan
AU - Englund, Martin
AU - Watt, Fiona E.
N1 - Publisher Copyright: © 2024 The Authors
PY - 2024/6
Y1 - 2024/6
N2 - Objective: The global impact of osteoarthritis is growing. Currently no disease modifying osteoarthritis drugs/therapies exist, increasing the need for preventative strategies. Knee injuries have a high prevalence, distinct onset, and strong independent association with post-traumatic osteoarthritis (PTOA). Numerous groups are embarking upon research that will culminate in clinical trials to assess the effect of interventions to prevent knee PTOA despite challenges and lack of consensus about trial design in this population. Our objectives were to improve awareness of knee PTOA prevention trial design and discuss state-of-the art methods to address the unique opportunities and challenges of these studies. Design: An international interdisciplinary group developed a workshop, hosted at the 2023 Osteoarthritis Research Society International Congress. Here we summarize the workshop content and outputs, with the goal of moving the field of PTOA prevention trial design forward. Results: Workshop highlights included discussions about target population (considering risk, homogeneity, and possibility of modifying osteoarthritis outcome); target treatment (considering delivery, timing, feasibility and effectiveness); comparators (usual care, placebo), and primary symptomatic outcomes considering surrogates and the importance of knee function and symptoms other than pain to this population. Conclusions: Opportunities to test multimodal PTOA prevention interventions across preclinical models and clinical trials exist. As improving symptomatic outcomes aligns with patient and regulator priorities, co-primary symptomatic (single or aggregate/multidimensional outcome considering function and symptoms beyond pain) and structural/physiological outcomes may be appropriate for these trials. To ensure PTOA prevention trials are relevant and acceptable to all stakeholders, future research should address critical knowledge gaps and challenges.
AB - Objective: The global impact of osteoarthritis is growing. Currently no disease modifying osteoarthritis drugs/therapies exist, increasing the need for preventative strategies. Knee injuries have a high prevalence, distinct onset, and strong independent association with post-traumatic osteoarthritis (PTOA). Numerous groups are embarking upon research that will culminate in clinical trials to assess the effect of interventions to prevent knee PTOA despite challenges and lack of consensus about trial design in this population. Our objectives were to improve awareness of knee PTOA prevention trial design and discuss state-of-the art methods to address the unique opportunities and challenges of these studies. Design: An international interdisciplinary group developed a workshop, hosted at the 2023 Osteoarthritis Research Society International Congress. Here we summarize the workshop content and outputs, with the goal of moving the field of PTOA prevention trial design forward. Results: Workshop highlights included discussions about target population (considering risk, homogeneity, and possibility of modifying osteoarthritis outcome); target treatment (considering delivery, timing, feasibility and effectiveness); comparators (usual care, placebo), and primary symptomatic outcomes considering surrogates and the importance of knee function and symptoms other than pain to this population. Conclusions: Opportunities to test multimodal PTOA prevention interventions across preclinical models and clinical trials exist. As improving symptomatic outcomes aligns with patient and regulator priorities, co-primary symptomatic (single or aggregate/multidimensional outcome considering function and symptoms beyond pain) and structural/physiological outcomes may be appropriate for these trials. To ensure PTOA prevention trials are relevant and acceptable to all stakeholders, future research should address critical knowledge gaps and challenges.
UR - http://www.scopus.com/inward/record.url?scp=85186749454&partnerID=8YFLogxK
U2 - 10.1016/j.ocarto.2024.100449
DO - 10.1016/j.ocarto.2024.100449
M3 - Article
C2 - 38440780
AN - SCOPUS:85186749454
SN - 2665-9131
VL - 6
JO - Osteoarthritis and Cartilage Open
JF - Osteoarthritis and Cartilage Open
IS - 2
M1 - 100449
ER -