Evaluation of a New Postoperative Dressing After Hallux Valgus Surgery
ConditionHallux Valgus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Assal for Foot Medicine and Surgery SA
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Custom 3D-printed toe spacer
DeviceA custom-made spacer designed to maintain hallux alignment after bunion surgery. It is produced individually for each participant using 3D-printing technology based on foot measurements. The device is manufactured from thermoplastic polyurethane (TPU), a biocompatible material commonly used for orthopedic applications. The spacer is externally applied between the hallux and second toe immediately following surgery and remains in place continuously for 5 weeks as part of routine postoperative care. The device does not contact the surgical wound, which is covered by a sterile dressing, and does not require any additional medical procedures for application or removal.
Standard folded-gauze toe spacer
DeviceParticipants receive a standard postoperative toe spacer consisting of folded medical gauze placed between the hallux and second toe immediately after surgery. The spacer is worn continuously for 5 weeks as part of routine care and represents the current standard method used at the study center.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: 3D-printed spacerExperimental treatment 1 intervention
Group B: Standard Folded-Gauze SpacerActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Patient tolerance to postoperative toe spacer
Patient tolerance measured using patient-reported comfort and pain on a 5-point Likert scale (Likert-type scale; minimum = 1, maximum = 5), where higher scores indicate better comfort and lower pain. Clinical evaluation will also assess the presence of skin irritation, redness, pressure marks or ulceration at 1 week, 3 weeks and 5 weeks after surgery.
Time frame
1 week, 3 weeks, and 5 weeks after surgerySponsors and contacts
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Source ClinicalTrials.gov