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A randomised controlled trial comparing post operative shoes following surgery of the first ray

FORFoot: A randomised controlled trial of clinical and radiological outcomes comparing reverse camber forefoot offloading shoes with rigid flat soled shoes in adult patients with surgery of the first ray:

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000200381
Acronym
Forefoot Offloader vs Rigid flat shoe in forefoot surgery (FORfoot)
Enrollment
100
Registered
2017-02-06
Start date
2016-02-19
Completion date
2017-11-27
Last updated
2018-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to assess whether in patients who have surgery of the first ray, a flat rigid soled shoe, when compared to a reverse camber offloading shoe is associated with the level of post operative pain, satisfaction and bony healing. (union and maintenance of correction.)

Interventions

intervention - rigid flat soled post operative shoe - The intervention group receive a rigid flat soled shoe. This is a stable device enabling near normal gait at the cost of putting pressure through the operated first ray. Patients will be given an information leaflet summarising the risks and benefits of a rigid flat post operative shoe when compared to the control which allows offloading of the operated forefoot and the expense of stability when mobilising. - The only difference between g

intervention - rigid flat soled post operative shoe - The intervention group receive a rigid flat soled shoe. This is a stable device enabling near normal gait at the cost of putting pressure through the operated first ray. Patients will be given an information leaflet summarising the risks and benefits of a rigid flat post operative shoe when compared to the control which allows offloading of the operated forefoot and the expense of stability when mobilising. - The only difference between groups will be the type of shoe they are given. All other operative techniques and post operative instructions will be standardised between groups. The shoe will be fitted in theatre by a trained member of the surgical team (specialist nurse or subspecialist foot and ankle fellow) and the patient will be mobilised on the ward by a trained physiotherapist and discharged when safely walking with the aid of two crutches. The patient information leaflet will include contact details of a member of the research team that they can contact if they have any queries or concerns. The shoe will be kept in place for 6 weeks and the only non standard post operative request will be for the patient to complete a patient reported outcome booklet containing the primary outcome measure and a secondary satisfaction measure. At one year all patients will be requested to complete a final radiograph which is not part of standard post operative care to assess for final radiographic outcome

Sponsors

Dr Andrew P Wines
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

primary surgery of the first ray- arthrodesis of the 1st metatarsophalangeal joint or scarf/akin osteotomy for hallux valgus

Exclusion criteria

revision surgery bilateral surgery first ray procedures other than those listed in the inclusion criteria (such as a lapidus fusion, dorsal cheilectomy and simple bunionectomy)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026