NCT07267156 Evaluation of a New Postoperative Dressing After Hallux Valgus Surgery

Eligibility & Interventions

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What to Expect as a Participant

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This trial targets 40 participants in total. It began in 2025-12-15 with a primary completion date of 2026-11-30.

Brief Summary

Hallux valgus, commonly known as a bunion, is a condition where the big toe deviates toward the other toes, often causing pain, difficulty with footwear, and decreased quality of life. Surgery can correct the alignment of the big toe, but during recovery the toes must be supported in the correct position so that the improvement is maintained. After this surgery, a spacer is usually placed between the big toe and the second toe for several weeks while the soft tissues heal. Standard spacers made of folded gauze are not custom-shaped to each patient's foot, which may lead to discomfort, skin irritation, or misalignment of the other toes. To address these limitations, a new custom-made spacer has been developed using 3D printing technology. This spacer is individually designed to match each patient's foot shape, with the goal of improving comfort and maintaining proper toe alignment throughout the healing phase. This clinical study will evaluate whether the custom-made 3D-printed spacer is better tolerated by patients than the traditional folded-gauze spacer and whether it helps maintain the corrected position of the big toe after surgery. The study will include 40 adults undergoing bunion surgery. Participants will be randomly assigned, like drawing lots, to receive either the 3D-printed spacer or the standard gauze spacer. Both spacers are applied externally during surgery and are worn continuously for five weeks as part of routine postoperative care. Participants will attend follow-up visits at 1 week, 3 weeks, and 5 weeks after surgery. At each visit, comfort, pain, and any skin irritation caused by the spacer will be evaluated. At the final visit, toe alignment will be assessed using routine weight-bearing X-rays and clinical examination. No additional medical procedures or radiation will be required beyond standard care. The hypothesis of this study is that the custom 3D-printed spacer will be well tolerated and will help maintain better toe alignment compared with the standard folded-gauze spacer. If successful, this personalized approach may improve recovery and patient satisfaction after bunion surgery.

Eligibility 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)

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