Custom 3D-printed toe spacer for bunion (hallux valgus) surgery recovery
Evaluation of a New Postoperative Dressing After Hallux Valgus Surgery
This will test whether a custom 3D-printed toe spacer is more comfortable and better at keeping the big toe aligned than a standard folded-gauze spacer for adults after hallux valgus surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Assal for Foot Medicine and Surgery SA Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Geneva, Canton of Geneva) |
| Trial ID | NCT07267156 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older undergoing a standard, single-sided hallux valgus corrective procedure at the Centre Assal who can follow postoperative visits and do not have a known TPU allergy are ideal candidates.
Not a fit: Patients planning bilateral hallux valgus surgery, those unable to comply with follow-up visits, or those with a known allergy to TPU may not receive benefit or are excluded from this option.
Why it matters
Potential benefit: If successful, the custom spacer could reduce discomfort and pressure-related skin problems while helping maintain surgical correction of the big toe, potentially improving recovery experience and outcomes.
How similar studies have performed: Custom 3D-printed orthotic devices have shown promise in other foot and orthotic applications, but use of a 3D-printed spacer specifically as a postoperative hallux valgus spacer is relatively new and not yet widely established.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Geneva, Canton of Geneva
- Centre Assal de médecin et chirurgie du pied — Geneva, Canton of Geneva, Switzerland (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.