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Clinical Trials Unit

BigTOE Inserts

Key information

Title:

Big Toe OstEoarthritis Trial: Inserts (BigTOE Inserts)

Chief Investigator: Associate Professor Michael Backhouse

Co-Chief Investigator: Professor Julie Bruce

Sponsor: University of Warwick

Funder: NIHR Health Technology Assessment Programme

Registration Number: TBC

Summary:

Osteoarthritis (OA) of the first metatarsophalangeal joint (1st MTPJ) is a painful condition that becomes more prevalent with age. Few studies have investigated whether carbon fibre shoe inserts can help reduce pain, improve function and quality of life. This will be the first UK study to investigate these inserts for people with painful 1st MTPJ OA.

Research question: What is the clinical and cost-effectiveness of carbon fibre inserts compared to sham inserts, for people with painful 1st MTPJ OA?

Sample size:

438

Primary outcome:

Assess foot function at 3 months post-randomisation, measured using the Manchester Oxford Foot Questionnaire (MOxFQ) standing/walking subscale.

Duration:

1st June 2024 - 30th November 2027.

This study is funded by the NIHR Health Technology Assessment (HTA) Programme (NIHR134398). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.

Contact Us:

Chief Investigator: Associate Professor Michael Backhouse

Co-Chief Investigator: Professor Julie Bruce

Trial Manager: Lauren Betteley

Tel: 02476 575111
Email: BigToeTrial@warwick.ac.uk

If you are interested in being a site for the BigTOE Inserts Trial, more information can be found here:

BigTOE Inserts Trial: Initial Study Information for Sites

Please complete the Site Expression of Interest form below:

Site Expression of Interest FormLink opens in a new window