Evaluation of a New Postoperative Dressing After Hallux Valgus Surgery

NCT07267156 | Recruiting

• 1 other identifier: 2025-00900
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hallux Valgus

Keywords

Hallux valgus; Postoperative dressing

Outcome Measures

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.

  1 week, 3 weeks, and 5 weeks after surgery

Study Arms (2)

3D-printed spacer

EXPERIMENTAL

3D-printed spacer

Device: Custom 3D-printed toe spacer

Standard Folded-Gauze Spacer

ACTIVE COMPARATOR

Participants 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.

Device: Standard folded-gauze toe spacer

Interventions

Custom 3D-printed toe spacer DEVICE

A 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.

3D-printed spacer

Standard folded-gauze toe spacer DEVICE

Participants 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.

Standard Folded-Gauze Spacer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Assal for Foot Medicine and Surgery SA: lead

Study Sites (1)

Centre Assal de médecin et chirurgie du pied

Geneva, Canton of Geneva, 1206, Switzerland

RECRUITING

Related Publications (5)

• Pentikainen I, Piippo J, Ohtonen P, Junila J, Leppilahti J. Role of Fixation and Postoperative Regimens in the Long-Term Outcomes of Distal Chevron Osteotomy: A Randomized Controlled Two-by-Two Factorial Trial of 100 Patients. J Foot Ankle Surg. 2015 May-Jun;54(3):356-60. doi: 10.1053/j.jfas.2014.08.001. Epub 2014 Oct 24.

  PMID: 25441855 BACKGROUND

• Choo YJ, Kim JH, Chang MC. Three-dimensional printing technology applied to the production of prosthesis: A systemic narrative review. Prosthet Orthot Int. 2024 Jun 18;49(3):344-352. doi: 10.1097/PXR.0000000000000366.

  PMID: 38896537 BACKGROUND

• Saragas NP. Clinical tip: postoperative dressing for hallux valgus surgery. Foot Ankle Int. 2005 Oct;26(10):899-900. doi: 10.1177/107110070502601018. No abstract available.

  PMID: 16221466 BACKGROUND

• Hester WA 3rd, Pedowitz DI. Postoperative Considerations in the Management of Hallux Valgus. Foot Ankle Clin. 2020 Mar;25(1):141-150. doi: 10.1016/j.fcl.2019.11.002.

  PMID: 31997741 BACKGROUND

• Nix S, Smith M, Vicenzino B. Prevalence of hallux valgus in the general population: a systematic review and meta-analysis. J Foot Ankle Res. 2010 Sep 27;3:21. doi: 10.1186/1757-1146-3-21.

  PMID: 20868524 BACKGROUND

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 5, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): April 15, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)