STOP KNEE-OA: AVOIDING COSTLY SURGERY THROUGH
WEIGHT LOSS

 

THE STOP-KNEE OA TRIAL

Subcutaneous Tirzepatide Once-weekly in Patients With Obesity and Knee Osteoarthritis (STOP KNEE-OA) Trial aims to systematically evaluate the efficacy and safety of a new hypoglycemic drug, tirzepatide, for treating obesity and knee osteoarthritis based on indicators such as BMI, waist circumference, and body weight.

ENROLMENT

352 Patients
18+ Years. All genders

INSIGHT:

Study start date: December 2024

Estimated study completion date: May 2037

NEWS

“Michelle Dowsey’s finding is part of the solution to Australia’s productivity problem, which is particularly acute in healthcare. The cost of medical and hospital services has tripled since 2000”

AUSTRALIAN FINANCIAL REVIEW

BACKGROUND

  • Obesity is not only a chronic metabolic disease, but also a major public health issue. In the past 50 years, the number of people worldwide suffering from obesity has tripled, with over 650 million adults considered obese and at least 1.9 billion adults overweight.

  • Knee replacements due to obesity consume more of the health budget than any other surgical procedure.

  • In an experiment on 82 very overweight patients at St Vincent’s Hospital in Melbourne, 29 per cent cancelled planned knee replacements after quickly losing weight. Their knees felt better.

  • The main purpose of this study is to see if tirzepatide can reduce number of these participants who require a knee replacement. Participants will be randomised to take a weekly injection of tirzepatide or a placebo for a total of 72 weeks.

  • STOP KNEE-OA has been designed to test multiple treatments within a common research platform. This design is more efficient and will lead to a shorter time for patients to receive effective treatments. The trial is 'eternal', which means that participants will continue to be recruited for many years until the trial is finally wound up. It is also 'adaptive', providing the flexibility to add new treatments, or remove those that are not working.

TRIAL DESIGN

  • Interventional, randomised clinical trial.

  • Drug: Tirzepatide is a glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1receptor (GLP1R) agonist Dose: Tirzepatide will be initiated at 2.5mg once weekly, with the dose increasing by a further 2.5mg every four weeks until the target weekly dose of 15mg is achieved (or participants reach a lower maximum tolerated dose of 5mg or 10mg).

  • Duration: 72-weeks Mode: subcutaneous

  • Location: Australia

  • 352 participants in two patient groups including a placebo group

  • Intervention Model: Parallel Assignment
    Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
    Primary Purpose: Treatment

  • Primary Outcome measures: Percentage of patients who undergo knee replacement in the target joint. Time Frame: within 72 weeks of randomization

KEY CONNECTIONS

“It is an incredibly agile environment. Whatever comes my way - I jump on it and deal with it”

Spiral’s contribution

Our Spiral Project Lead and EDC Product Owner for the STOP KNEE-OA study is Amanda Daley

As a Product Owner at Spiral, Amanda oversees software development used in clinical trials. She thrives on solving complex problems and brings a logical mindset to building smarter, streamlined digital platforms.