Custom 3D-printed toe spacer for bunion (hallux valgus) surgery recovery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, randomized controlled trial comparing a custom-made 3D-printed thermoplastic polyurethane (TPU) spacer to a standard folded-gauze spacer in adults undergoing hallux valgus corrective surgery. Forty participants will be randomly assigned 1:1 to receive either the custom spacer or the standard spacer after surgery, with the device applied externally and not entering the wound. The custom spacer is individually designed from foot anatomy using 3D printing with the aim of improving comfort and maintaining toe alignment during early soft-tissue healing. The study will collect feasibility, tolerance, and early alignment outcomes during routine postoperative follow-up visits at the study center.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults aged 18 years or older
* Diagnosis of hallux valgus requiring surgical correction
* Undergoing a standard hallux valgus procedure at the study center
* Able to comply with study procedures and follow-up visits
* Signed informed consent obtained before participation

Exclusion Criteria:

* Inability to provide informed consent
* Inability to comply with study procedures or follow-up visits
* Insufficient language comprehension for study instructions
* Bilateral hallux valgus surgery planned
* Known allergy or hypersensitivity to thermoplastic polyurethane (TPU)

Where it's running

• Centre Assal de médecin et chirurgie du pied
  Geneva, Canton of Geneva, Switzerland Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.