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The Use of 3D-Printed Silicone Toe Separator on Adults with Bunions: Uncontrolled Intervention Trial

The Use of 3D-Printed Silicone Toe Separator on Foot Pain in Adults with Hallux Valgus: Uncontrolled Intervention Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000329561
Enrollment
27
Registered
2024-03-25
Start date
2023-03-02
Completion date
2023-03-30
Last updated
2024-04-01

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

Conditions

None listed

Brief summary

Hallux valgus presents with pain and a progressive valgus deformity of the first ray. The newly designed silicone toe separators fabricated by 3D printing technology are used for 12-week treatment. The pain score and foot function index (FFI) are rated, and hallux valgus angle are measured before and after intervention to investigate the treatment effectiveness.

Interventions

Patient with hallux valgus receives 3D-printed silicone toe separator and use it for the complete 12-week duration of the study. The patients must wear the silicone toe separators during the night for a minimum of 4 hours as recommended by a physiatrist. They must record wearing hours daily and being examined by a physiatrist after 2 and 12 weeks of intervention.

Sponsors

National Science and Technology Development Agency (NSTDA)
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

Hallux valgus patients with pain score between 3 to 8 for a minimum of 4 weeks.

Exclusion criteria

Those who has rigid foot deformity, a previous 1-year foot surgery, a medical history of steroid injections within the past 3 months, and other health problems associated with walking ability such as knee arthritis, diabetes, peripheral artery disease, and peripheral neuropathy were excluded.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026