None listed
Conditions
Brief summary
Shoe inserts may be used after surgery for bunions and are proposed to help support the foot, reduce pain and improve the movement in the first toe joint. However it is unknown whether having shoe inserts soon after surgery or waiting for complete healing is better to achieve these outcomes. This study will investigate if early (6 week) intervention or later (12 week) intervention with shoe inserts is better for improving first toe joint pain and range of motion following a first metatarsal distal osteotomy with fixation.
Interventions
Shoe insert intervention following first metatarsal distal osteotomies with fixation.
1. Group 1: Orthotic intervention 6 weeks after osteotomy (20 participants).
Group 2: Orthotic intervention 12 weeks after osteotomy (20 participants).
Group 3: Sham orthotics at either 6 or 12 weeks after osteotomy (10 participants in each group).
2. A standard full length pre-fabricated orthotic will be used (footbionics).
3. Surgeons and the administering podiatrist will be monitoring the intervention.
4. Du
Shoe insert intervention following first metatarsal distal osteotomies with fixation. 1. Group 1: Orthotic intervention 6 weeks after osteotomy (20 participants). Group 2: Orthotic intervention 12 weeks after osteotomy (20 participants). Group 3: Sham orthotics at either 6 or 12 weeks after osteotomy (10 participants in each group). 2. A standard full length pre-fabricated orthotic will be used (footbionics). 3. Surgeons and the administering podiatrist will be monitoring the intervention. 4. Duration of wear will be 6 weeks and will be on a daily basis for at least 80% of daily gait. 5. There will be a diary to record and assess adherence to the orthotic intervention.
Sponsors
Fayad podiatry clinic
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
If you are having a first metatarsal distal osteotomies with fixation and have a flat foot type as determined through assessment by a researcher and are over 18 years of age you are eligible for inclusion in this study.
Exclusion criteria
If first metatarsal distal osteotomies with fixation is combined with other forefoot procedures the patient will be excluded from the study.
Outcome results
None listed