Study Comparing a Custom 3D-Printed Toe Spacer Versus Standard Gauze Spacer After Bunion Surgery to Improve Comfort and Toe Alignment

What this Trial Is About

Hallux valgus, commonly called a bunion, is a condition where the big toe bends toward the other toes, often causing pain and difficulty wearing shoes. Surgical correction realigns the toe, but during recovery, a toe spacer is used to keep the toes properly positioned while soft tissues heal. This study evaluates whether a new custom-made 3D-printed toe spacer is better tolerated and helps maintain toe alignment compared to the standard folded-gauze spacer after bunion surgery. The trial includes 40 adults undergoing hallux valgus surgery, randomly assigned to receive either the 3D-printed spacer or the standard gauze spacer. The custom spacer is made individually for each patient using 3D printing technology and thermoplastic polyurethane, a biocompatible material used in orthopedic devices. It is placed externally between the big toe and second toe immediately after surgery and worn continuously for five weeks as part of routine postoperative care. The standard group receives the usual folded gauze spacer, also worn continuously for five weeks. Both spacers are non-invasive and applied immediately after surgery. Participants will have follow-up visits at 1 week, 3 weeks, and 5 weeks after surgery to assess comfort, pain, and any skin irritation from the spacer. At the final visit, toe alignment will be checked using routine weight-bearing X-rays and clinical examination. No extra medical procedures or radiation beyond standard care are needed. The main goal is to see if the 3D-printed spacer is better tolerated, with secondary goals assessing toe alignment and spacer-related side effects during this five-week period.

Evaluation of a New Postoperative Dressing After Hallux Valgus Surgery