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Comparison of stiff sole shoes vs flexible sole shoes (sneakers) on foot and ankle function in patients undergoing forefoot surgery

Comparison of Rigid Flat Shoes Versus Flexible Sole Shoes on Foot and Ankle Function in Patients Undergoing Forefoot Surgical Treatment (ComForT)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000262808
Acronym
ComForT
Enrollment
100
Registered
2021-03-10
Start date
2022-07-01
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

None listed

Brief summary

With novel surgical techniques and hardware design, plaster casts are not necessary to immobilise feet after 1st metatarsal surgery. Most surgeons support the use of a stiff sole post-operative shoe in either partial or full weight bearing to protect the surgical site and prevent complications over the course of 6 weeks post-surgery. We have previously demonstrated the use of rigid flat shoes improves satisfaction over the use of reverse camber shoe. The purpose of this study is to assess whether the use of comfortable shoes vs stiff sole shoes affects patient reported outcomes. Differences in long-term surgical outcomes of non-union and recurrence will also be investigated.

Interventions

Comfortable lace up shoes (e.g. sneaker) owned by the participant will be worn 2 weeks after surgery. The shoes will be worn while the patient is weight bearing, i.e. walking for any length of time. The shoes may be removed for sleeping or when the patient is not weight bearing. This will start at 2 weeks post surgery. This will be needed for at least unto 6 weeks after surgery. As these are the patient's own lace up shoes, they may continue to wear these in the future as they wish. The interven

Comfortable lace up shoes (e.g. sneaker) owned by the participant will be worn 2 weeks after surgery. The shoes will be worn while the patient is weight bearing, i.e. walking for any length of time. The shoes may be removed for sleeping or when the patient is not weight bearing. This will start at 2 weeks post surgery. This will be needed for at least unto 6 weeks after surgery. As these are the patient's own lace up shoes, they may continue to wear these in the future as they wish. The intervention will administered by the orthopaedic surgeon/staff in the clinic at their 2 weeks post surgery visit. The patient will be reminded to bring their shoes to this visit. Adherence will not be measured

Sponsors

Andrew 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 80 Years
Healthy volunteers
No

Inclusion criteria

Patients between the ages of 18 to 80 (inclusive) undergoing 1st ray surgery surgery (either scarf and akin osteotomies for hallux valgus correction or first MTP joint fusion) will be recruited. Patients undergoing concomitant additional forefoot procedures (such as interphalangeal joint (IPJ) fusion of lesser toes, soft tissue corrective procedures, or excision of Morton’s neuroma) will be included.

Exclusion criteria

Exclusion criteria will be bilateral surgery, revision procedures, additional foot arthrodesis or osteotomy procedures performed proximal to the forefoot, not willing to participate in the trial, cognitive impairment that may impair the patient’s ability to follow post-operative instructions or unable to provide informed consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026