The osteoarthritis prevention study (TOPS) - A randomized controlled trial of diet and exercise to prevent Knee Osteoarthritis: Design and rationale

Stephen P. Messier; Leigh F. Callahan; Elena Losina; Shannon L. Mihalko; Ali Guermazi; Edward Ip; Gary D. Miller; Jeffrey N. Katz; Richard F. Loeser; Brian G. Pietrosimone; Sandra Soto; James L. Cook; Jovita J. Newman; Paul DeVita; Kurt P. Spindler; Jos Runhaar; Cortney Armitano-Lago; Vicky Duong; Faith Selzer; Ryan Hill; Monica Love; Daniel P. Beavers; Santiago Saldana; Aaron M. Stoker; Paige E. Rice; David J. Hunter

Osteoarthritis and Cartilage Open (Mar 2024)

The osteoarthritis prevention study (TOPS) - A randomized controlled trial of diet and exercise to prevent Knee Osteoarthritis: Design and rationale

Stephen P. Messier,
Leigh F. Callahan,
Elena Losina,
Shannon L. Mihalko,
Ali Guermazi,
Edward Ip,
Gary D. Miller,
Jeffrey N. Katz,
Richard F. Loeser,
Brian G. Pietrosimone,
Sandra Soto,
James L. Cook,
Jovita J. Newman,
Paul DeVita,
Kurt P. Spindler,
Jos Runhaar,
Cortney Armitano-Lago,
Vicky Duong,
Faith Selzer,
Ryan Hill,
Monica Love,
Daniel P. Beavers,
Santiago Saldana,
Aaron M. Stoker,
Paige E. Rice,
David J. Hunter

Affiliations

Stephen P. Messier: J.B. Snow Biomechanics Laboratory, Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA; Corresponding author. J.B. Snow Biomechanics Laboratory, Department of Health & Exercise Science, Wake Forest University, Winston-Salem, NC, 27109, USA.
Leigh F. Callahan: Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
Elena Losina: Orthopedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA
Shannon L. Mihalko: Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA
Ali Guermazi: Boston University School of Medicine, Boston, MA, USA
Edward Ip: Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA
Gary D. Miller: Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA
Jeffrey N. Katz: Orthopedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA
Richard F. Loeser: Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
Brian G. Pietrosimone: Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
Sandra Soto: Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
James L. Cook: Department of Orthopaedic Surgery, Thompson Laboratory for Regenerative Orthopaedics, Missouri Orthopaedic Institute, University of Missouri School of Medicine, Columbia, MO, USA
Jovita J. Newman: J.B. Snow Biomechanics Laboratory, Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA
Paul DeVita: Department of Kinesiology, East Carolina University, Greenville, NC, USA
Kurt P. Spindler: Clinical Research and Outcomes, Cleveland Clinic Florida, Weston, FL, USA
Jos Runhaar: Erasmus MC University Medical Center Rotterdam, Department of General Practice, Rotterdam, the Netherlands
Cortney Armitano-Lago: Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
Vicky Duong: Sydney Musculoskeletal Health, Kolling Institute, University of Sydney, Sydney, Australia
Faith Selzer: Orthopedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA
Ryan Hill: J.B. Snow Biomechanics Laboratory, Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA
Monica Love: Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA
Daniel P. Beavers: Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA
Santiago Saldana: Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA
Aaron M. Stoker: Department of Orthopaedic Surgery, Thompson Laboratory for Regenerative Orthopaedics, Missouri Orthopaedic Institute, University of Missouri School of Medicine, Columbia, MO, USA
Paige E. Rice: J.B. Snow Biomechanics Laboratory, Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA
David J. Hunter: Sydney Musculoskeletal Health, Kolling Institute, University of Sydney, Sydney, Australia; Rheumatology Department, Royal North Shore Hospital, Sydney, Australia

Journal volume & issue: Vol. 6, no. 1
p. 100418

Abstract

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Background: Osteoarthritis (OA), the leading cause of disability among adults, has no cure and is associated with significant comorbidities. The premise of this randomized clinical trial is that, in a population at risk, a 48-month program of dietary weight loss and exercise will result in less incident structural knee OA compared to control. Methods/design: The Osteoarthritis Prevention Study (TOPS) is a Phase III, assessor-blinded, 48-month, parallel 2 arm, multicenter randomized clinical trial designed to reduce the incidence of structural knee OA. The study objective is to assess the effects of a dietary weight loss, exercise, and weight-loss maintenance program in preventing the development of structural knee OA in females at risk for the disease. TOPS will recruit 1230 ambulatory, community dwelling females with obesity (Body Mass Index (BMI) ≥ 30 kg/m2) and aged ≥50 years with no radiographic (Kellgren-Lawrence grade ≤1) and no magnetic resonance imaging (MRI) evidence of OA in the eligible knee, with no or infrequent knee pain. Incident structural knee OA (defined as tibiofemoral and/or patellofemoral OA on MRI) assessed at 48-months from intervention initiation using the MRI Osteoarthritis Knee Score (MOAKS) is the primary outcome. Secondary outcomes include knee pain, 6-min walk distance, health-related quality of life, knee joint loading during gait, inflammatory biomarkers, and self-efficacy. Cost effectiveness and budgetary impact analyses will determine the value and affordability of this intervention. Discussion: This study will assess the efficacy and cost effectiveness of a dietary weight loss, exercise, and weight-loss maintenance program designed to reduce incident knee OA. Trial registration: ClinicalTrials.gov Identifier: NCT05946044.

Published in Osteoarthritis and Cartilage Open

ISSN: 2665-9131 (Online)
Publisher: Elsevier
Country of publisher: United Kingdom
LCC subjects: Medicine: Internal medicine: Specialties of internal medicine: Diseases of the musculoskeletal system
Website: https://www.journals.elsevier.com/osteoarthritis-and-cartilage-open/

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