FOOTSTEP Paterson 2021

The University of Melbourne

Dataset description

Demographic, baseline and 6-month follow-up data from the FOOTSTEP trial. 164 patients aged over 50 years with moderate to severe symptomatic radiographic medial knee osteoarthritis. Intervention was flat flexible (n = 82) or stable supportive shoes (n = 82), worn for at least 6 hours a day for 6 months. All data presented in the results paper (Annals of internal medicine. 2021;174:462-471) available in XLSX format.
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Source Study

Trial acronym

Not available

Trial ID





Not Applicable


Government body,National Health and Medical Research Council

Scientific enquiries

Prof Rana Hinman

Brief Summary

Knee osteoarthritis is a major problem in Australia and there is no cure for the disease. Non-drug strategies that help people to self-manage the condition are needed. Different types of shoes influence forces acting across the knee joint. We know that increased knee forces can contribute to the knee pain associated with knee osteoarthritis, and that high forces can increase the risk of the disease worsening over time. It is recommended that clinicians provide advice on “appropriate” footwear fo ....
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Key Inclusion Criteria

i) aged greater than or equal to 50 years; ii) report knee pain on most days of the past month; iii) report a minimum pain score of 4 on an 11-point numeric rating scale during walking over the previous week; iv) demonstrate tibiofemoral osteophytes on x-ray; and v) demonstrate moderate-severe (Grade 3-4) tibiofemoral OA on x-ray as determined by the Kellgren & Lawrence grading system

Key Exclusion Criteria

i) Lateral joint space narrowing greater than or equal to medial joint space narrowing on x-ray; ii) suffered knee pain for <3 months; iii) recent knee surgery (past 6 months) or planned surgery in next 6 months; iv) current use of shoe orthoses, customized shoes or ankle braces; v) current primary use of high heels, thongs or work boots that would restrict ability to wear study shoes 6 hours/day; vi) had a hip or knee replacement on either side; vii) had a high tibial osteotomy on either leg; v ....
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Can healthy volunteers participate?




Sample Size    164

Min. age    50 Years

Max. age    No limit

Sex    Both males and females

Condition category    Knee osteoarthritis

Condition code    Musculoskeletal


Intervention code Treatment: Other

This comparative effectiveness trial will compare two different classes of footwear: Flat flexible shoes- selected from commercially available footwear, that fulfill previously published criteria for flat flexible shoes (Paterson et al, 2017, Osteoarthritis & Cartilage). These criteria are: 1) heel height of less than 15mm; 2) shoe pitch of less than 10mm; 3) absence of arch support or motion control; 4) have "minimal" rigidity (Barton et al. 2009, J Foot Ankle Res); and 5) weigh 200g or less (+ ....
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Control group Active

We are comparing the effects of the two footwear classes described under “intervention”.


Outcome: Severity of knee pain while walking Scored on an 11-point numerical rating scale (NRS) for average overall pain on walking in the last week. Ranges from 0 to 10; where 0=no pain and 10=worst pain possible.
Timepoint: Baseline, and 6 months after randomization

Outcome: Physical function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Scored using 17 questions regarding knee function in the last week, with Likert response options ranging from None to Extreme. WOMAC scores will be extracted from the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire, which contains the WOMAC questions. Total score ranges from 0 to 68; higher scores indicate worse function.
Timepoint: Baseline, ....

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Study Protocol: Not Available
Data Dictionary: Data dictionary

Will individual participant data (IPD) for this trial be available?


What data in particular will be shared?

All data presented in the results paper (Annals of internal medicine. 2021;174:462-471) available in XLSX format.

When will data be available?

12-01-2021 to 12-01-2036 (a period of 15 years from publication)

Available to whom?

Data will be made available as required for specific, approved analyses by researchers. Data will be provided from locked, cleaned, and de- identified study database. Requests will be reviewed by the Principal Investigator prior to approval.

Available for what types of analyses?

The investigators endorse the concept of data sharing to advance medical science. All requests for data sharing will be reviewed by the Principal Investigator to ensure no conflict with any planned sub analyses and to ensure that the data are shared in an ethical and protected manner. Analyses aimed to improve treatment of knee osteoarthritis for non-commercial purposes are eligible.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see