FORT Paterson 2022
The University of MelbourneDataset description
Demographic, baseline and 12-weeks follow-up data from the FORT trial. 88 patients aged over 45 years with symptomatic radiographic first MTP joint osteoarthritis. Intervention was contoured foot orthoses (n = 47) or sham flat insoles (n = 41), worn at all times for 12 weeks. All data presented in the results paper (Osteoarthritis Cartilage. 2022;30(7):956-964) available in XLSX format.Identifiers
Source Study
Trial name (public)
Foot ORthoses for big Toe joint osteoarthritis: the FORT randomised controlled trialTrial acronym
FORT (Foot ORthoses for big Toe joint osteoarthritis)
Trial ID
ACTRN12619000926134
Purpose
Treatment
Phase
Not Applicable
Funding
Government body,National Health and Medical Research Council (NHMRC)
Scientific enquiries
Dr Kade Paterson
Brief Summary
The overall aim of this research is to compare the effects of using special contoured insoles compared to flat insoles in people who suffer painful osteoarthritis (OA) in their big toe joint. To test this, participants who have big toe OA and are eligible to take part in the study, will be allocated into two different insole groups via a random process. All participants will see a podiatrist who will provide one pair of insoles (either flat or contoured depending on which group they are in), whi .... Read more
Key Inclusion Criteria
i) aged 45 years or older, ii) report first MTP joint pain on most days of the month for at least 12 weeks, iii) report a minimum pain score of 3 on an 11-point numerical rating scale during walking over the previous week, iv) evidence of radiographic osteoarthritis (OA) (a score of 2 or more for osteophytes or joint space narrowing according to a radiographic atlas), due to a lack of accepted clinical diagnostic criteria for first MTP joint OA, and v) report either no morning joint-related stif .... Read more
Key Exclusion Criteria
i) previous foot surgery or planned surgery on the affected side in the next 12 weeks; ii) current use of foot orthoses or ankle braces, iii) current primary use of high heels, thongs or other shoes that would restrict ability to wear orthoses, iv) had any foot injections on the affected side in the past 6 months or planned injections in next 12 weeks, v) self-report any other current muscular, joint or neurological condition affecting lower limb function, vi) self-report any systemic or inflamm .... Read more
Can healthy volunteers participate?
No
Population
Sample Size 88
Min. age 45 Years
Max. age No limit
Sex Both males and females
Condition category First metatarsophalangeal (big toe) joint osteoarthritis
Condition code Musculoskeletal
Intervention
Intervention code Treatment: Devices
This randomised controlled trial (RCT) involves an intervention group and a control group. Participants in both groups will have two visits with a study podiatrist in weeks 1 and 3, booked following completion of the baseline questionnaire by a study researcher. The initial consultation will be 30 minutes and the follow-up visit will be 15-minute 2 weeks later. The intervention group will receive foot orthoses, for both feet, protocolised (whilst allowing some individual variation) to ensure con .... Read more
Comparison
Control group Placebo
Participants in the control group will be provided with a sham flat 3mm prefabricated insole for each foot that is the same colour, density and has the same branding as the contoured foot orthoses used in the intervention group, but without the heel and arch support. The flat insole will be trimmed (if needed) and fitted to the participant’s footwear at the initial visit. At this time, participants will be advised to initially commence wearing the flat insole for 1 hour on the first day, and to .... Read more
Outcomes
Outcome: Severity of first metatarsophalangeal (MTP) joint pain during walking. Scored on an 11-point numerical rating scale (NRS) for average overall pain on walking in the last week. The scale ranges from 0 to 10; where 0=no pain and 10=worst pain possible. Timepoint: Baseline and 12 weeks post commencement of treatment
Will individual participant data (IPD) for this trial be available?
yes
What data in particular will be shared?
All data presented in the results paper (Osteoarthritis Cartilage. 2022;30(7):956-964.) available in XLSX format.
When will data be available?
07-03-2022 to 07-03-2037 (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.