Journal article
The PIKASO Trial (Preventing Injured Knees from Osteoarthritis: Severity Outcomes): Rationale and Design Features for a Randomized Controlled Trial
Osteoarthritis and cartilage open, Vol.7(1), 100563
03/2025
DOI: 10.1016/j.ocarto.2024.100563
PMCID: PMC11758201
PMID: 39867299
Abstract
Given the high burden and increasing prevalence of post-traumatic osteoarthritis (PTOA), identifying clinically beneficial strategies to prevent or delay its onset could improve the quality of life of those at high risk of developing the disease.
Preventing Injured Knees from OsteoArthritis: Severity Outcomes (PIKASO) is a multicenter blinded, parallel, two-arm randomized controlled trial of 512 individuals aged 18-45 years undergoing anterior cruciate ligament reconstruction (ACLR). This study is designed to evaluate the efficacy of a 12-month intervention of oral metformin vs. placebo in decreasing the rate of structural knee changes and pain. Participants will be asked to take up to 1500 mg/day of either metformin or placebo as tolerated. The primary outcomes are Knee injury and Osteoarthritis Outcome Score (KOOS) Pain subscales scores averaged between 12 and 24 months after randomization, and MRI derived cartilage structural change at 24 months. The trial will be deemed successful if at least one of the two primary outcomes reaches the preplanned effect size with sufficient statistical certainty. In this paper, we describe PIKASO elements according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines.
Our multidisciplinary team developed the methods and statistical analysis plan for a placebo controlled, randomized clinical trial to determine whether metformin alters pain and early osteoarthritic changes after ACLR.
This manuscript outlines the rationale, study design, and implementation of the PIKASO trial aiming to prevent the onset of PTOA after ACLR.
Clinicaltrials.gov NCT06096259
Details
- Title: Subtitle
- The PIKASO Trial (Preventing Injured Knees from Osteoarthritis: Severity Outcomes): Rationale and Design Features for a Randomized Controlled Trial
- Creators
- Cale A. Jacobs - Brigham and Women's HospitalMorgan H. Jones - Brigham and Women's HospitalJamie E. Collins - Brigham and Women's HospitalLily M. Waddell - Brigham and Women's HospitalXiaojuan Li - Cleveland ClinicCarl S. Winalski - Cleveland ClinicBrian Pietrosimone - University of North Carolina at Chapel HillVirginia Byers Kraus - Duke University School of MedicineMiguel Otero - Hospital for Special SurgeryElizabeth Wellsandt - University of Nebraska Medical CenterLaura C. Schmitt - The Ohio State UniversityKurt P. Spindler - Cleveland ClinicDonald D. Anderson - University of Iowa, Iowa City, IAScott A. Rodeo - Hospital for Special SurgeryRobert A. Magnussen - The Ohio State UniversityBrian R. Wolf - University of Iowa, Iowa City, IAJoe M. Hart - University of North Carolina at Chapel HillAustin V. Stone - University of KentuckyCaitlin E. Conley - University of KentuckyYvonne M. Golightly - University of Nebraska Medical CenterGregory D. Myer - Emory UniversityLynn Snyder-Mackler - University of DelawareMartin K. Lotz - Scripps Research InstituteJason S. Kim - Arthritis FoundationMichelle M. McLeod - Arthritis FoundationJanet L. Huebner - Duke University School of MedicineCaroline Lisee - University of GeorgiaFaith Selzer - Brigham and Women's HospitalJeffrey N. Katz - Brigham and Women's HospitalKyna Long - Brigham and Women's HospitalKelly C. Frier - Brigham and Women's HospitalDaniel J. Betensky - Brigham and Women's HospitalDavid T. Felson - Boston University School of MedicineElena Losina - Brigham and Women's HospitalPIKASO Team
- Resource Type
- Journal article
- Publication Details
- Osteoarthritis and cartilage open, Vol.7(1), 100563
- DOI
- 10.1016/j.ocarto.2024.100563
- PMID
- 39867299
- PMCID
- PMC11758201
- NLM abbreviation
- Osteoarthr Cartil Open
- ISSN
- 2665-9131
- eISSN
- 2665-9131
- Publisher
- Elsevier Ltd; AMSTERDAM
- Grant note
- Arthritis Foundation Osteoarthritis Clinical Trial Network
Funding was provided by the Arthritis Foundation Osteoarthritis Clinical Trial Network. Arthritis Foundation representatives (Jason Kim, Michelle McLeod) contributed to study design and writing of the manuscript. The funding source will not be involved with data collection, analysis or interpretation, or the decision to submit the manuscript for publication.
- Language
- English
- Electronic publication date
- 12/23/2024
- Date published
- 03/2025
- Academic Unit
- Roy J. Carver Department of Biomedical Engineering; Orthopedics and Rehabilitation; Industrial and Systems Engineering; Physical Therapy and Rehabilitation Science
- Record Identifier
- 9984770789802771
Metrics
49 Record Views