Hallux Valguspsmt3DNCT07267156
Evaluation of a New Postoperative Dressing After Hallux Valgus Surgery
A study testing Custom 3D-printed toe spacer and Standard folded-gauze toe spacer in people with Hallux Valgus, run by Centre Assal for Foot Medicine and Surgery SA at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- Custom 3D-printed toe spacer and Standard folded-gauze toe spacer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Dec 2025to 15 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Centre Assal de médecin et chirurgie du pied
Geneva, Canton of Geneva, 1206
Antoine S Acker, MD, 22 566 54 ext. +41, antoine.acker@centre-assal.ch
Victor Dubois-Ferriere, MD
About this study
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.
Read more
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.
Read the detailed description
Hallux valgus is a common forefoot deformity characterized by lateral deviation of the hallux and medial deviation of the first metatarsal. Surgical correction is performed to restore alignment and relieve symptoms, but postoperative soft tissue healing requires mechanical support to maintain the correction during early recovery. A toe spacer is routinely used for this purpose, generally applied between the hallux and second toe for several weeks after surgery.
Traditional spacers, typically fabricated from folded gauze, are non-custom solutions that may not conform to the patient's individual anatomy. As a result, they may cause discomfort, pressure areas, or misalignment of the lesser toes. To overcome these limitations, a custom-made spacer has been designed using 3D-printing technology. The device is manufactured from thermoplastic polyurethane (TPU), a biocompatible material commonly used in orthotic applications. It is externally applied and does not enter the surgical wound. The device is intended to improve comfort and maintain postoperative hallux alignment more effectively than standard spacers.
This study is a single-center randomized controlled trial evaluating the feasibility, tolerance, and early alignment outcomes associated with the use of the custom-made 3D-printed spacer compared to standard folded-gauze spacers. Forty adult participants undergoing hallux valgus surgical correction will be randomly allocated in a 1:1 ratio to the intervention or control group through sealed opaque envelopes prepared prior to study initiation. Both interventions are non-invasive and part of routine postoperative care.
The spacer will be applied immediately after surgery and continuously maintained for five weeks. Standardized follow-up evaluations will be performed at 1, 3, and 5 weeks after surgery. Tolerance of the device will be assessed using patient-reported comfort and pain scores and clinical evaluation of skin condition, including the presence of irritation, redness, pressure marks, or ulceration. Alignment outcomes will be assessed at the final follow-up visit using routine weight-bearing radiographs and clinical examination.
The primary aim of this investigation is to assess the tolerance of the custom-made 3D-printed postoperative spacer. Secondary aims include the evaluation of hallux and lesser-toe alignment at five weeks and the documentation of spacer-related adverse events. Because this is an early clinical assessment of a new supportive postoperative device, the study is designed as a minimal-risk feasibility trial with a pragmatic sample size.
All surgical procedures and postoperative care will be conducted by fellowship-trained foot and ankle surgeons using standardized techniques. To minimize bias, allocation concealment is ensured by the envelope randomization method, follow-up timing is standardized, and imaging evaluation will be performed based on prespecified measurement criteria.
No additional imaging, radiation exposure, or medical procedures are required beyond standard postoperative care, and participation does not alter the surgical treatment plan. The study is classified under Risk Category A according to the Swiss Human Research Ordinance (HRO), as the device does not pose significant additional risks or burdens beyond normal clinical practice.
The findings of this study will provide preliminary evidence on the clinical feasibility and patient acceptance of customized postoperative spacers following hallux valgus surgery. Positive results may support future larger-scale trials designed to assess long-term clinical outcomes and validate the benefits of individualized postoperative support in forefoot surgical care.
- Conditions
- Hallux Valgus
- Being tested
- Custom 3D-printed toe spacer, Standard folded-gauze toe spacer
- Keywords
- Hallux valgus, Postoperative dressing
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom 3D-printed toe spacerDevice
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.
Standard folded-gauze toe spacerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 3D-printed spacer | Experimental | 3D-printed spacer Receives: 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. Receives: Device: Standard folded-gauze toe spacer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week, 3 weeks, and 5 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Assal for Foot Medicine and Surgery SA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267156
- Sponsor's protocol ID
- 2025-00900
- Other IDs
- 2025
- Acronym
- psmt3D
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because this is a small, single-center study involving identifiable clinical and imaging data that cannot be fully anonymized while maintaining scientific value. Only aggregated results will be published in peer-reviewed journals.
Publications
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.
PubMed 25441855Choo 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.
PubMed 38896537Saragas 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.
PubMed 16221466Hester 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.
PubMed 31997741Nix 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.
PubMed 20868524
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Postoperative Dressing After Hallux Valgus Surgery
- ClinicalTrials.gov ID
- NCT07267156
- Acronym / sponsor ID
- psmt3D / 2025-00900
- Conditions
- Hallux Valgus
- Keywords
- Hallux valgus, Postoperative dressing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Assal for Foot Medicine and Surgery SAUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hallux valgus is a common forefoot deformity characterized by lateral deviation of the hallux and medial deviation of the first metatarsal. Surgical correction is performed to restore alignment and relieve symptoms, but postoperative soft tissue healing requires mechanical support to maintain the correction during early recovery. A toe spacer is routinely used for this purpose, generally applied between the hallux and second toe for several weeks after surgery.
Traditional spacers, typically fabricated from folded gauze, are non-custom solutions that may not conform to the patient's individual anatomy. As a result, they may cause discomfort, pressure areas, or misalignment of the lesser toes. To overcome these limitations, a custom-made spacer has been designed using 3D-printing technology. The device is manufactured from thermoplastic polyurethane (TPU), a biocompatible material commonly used in orthotic applications. It is externally applied and does not enter the surgical wound. The device is intended to improve comfort and maintain postoperative hallux alignment more effectively than standard spacers.
This study is a single-center randomized controlled trial evaluating the feasibility, tolerance, and early alignment outcomes associated with the use of the custom-made 3D-printed spacer compared to standard folded-gauze spacers. Forty adult participants undergoing hallux valgus surgical correction will be randomly allocated in a 1:1 ratio to the intervention or control group through sealed opaque envelopes prepared prior to study initiation. Both interventions are non-invasive and part of routine postoperative care.
The spacer will be applied immediately after surgery and continuously maintained for five weeks. Standardized follow-up evaluations will be performed at 1, 3, and 5 weeks after surgery. Tolerance of the device will be assessed using patient-reported comfort and pain scores and clinical evaluation of skin condition, including the presence of irritation, redness, pressure marks, or ulceration. Alignment outcomes will be assessed at the final follow-up visit using routine weight-bearing radiographs and clinical examination.
The primary aim of this investigation is to assess the tolerance of the custom-made 3D-printed postoperative spacer. Secondary aims include the evaluation of hallux and lesser-toe alignment at five weeks and the documentation of spacer-related adverse events. Because this is an early clinical assessment of a new supportive postoperative device, the study is designed as a minimal-risk feasibility trial with a pragmatic sample size.
All surgical procedures and postoperative care will be conducted by fellowship-trained foot and ankle surgeons using standardized techniques. To minimize bias, allocation concealment is ensured by the envelope randomization method, follow-up timing is standardized, and imaging evaluation will be performed based on prespecified measurement criteria.
No additional imaging, radiation exposure, or medical procedures are required beyond standard postoperative care, and participation does not alter the surgical treatment plan. The study is classified under Risk Category A according to the Swiss Human Research Ordinance (HRO), as the device does not pose significant additional risks or burdens beyond normal clinical practice.
The findings of this study will provide preliminary evidence on the clinical feasibility and patient acceptance of customized postoperative spacers following hallux valgus surgery. Positive results may support future larger-scale trials designed to assess long-term clinical outcomes and validate the benefits of individualized postoperative support in forefoot surgical care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D-printed spacer | Experimental | Device: Custom 3D-printed toe spacer3D-printed spacer |
| Standard Folded-Gauze Spacer | Active comparator | Device: Standard folded-gauze toe spacerParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Custom 3D-printed toe spacerA 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. | Device | 3D-printed spacer |
| Standard folded-gauze toe spacerParticipants 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 Spacer |
Primary outcome
Patient tolerance to postoperative toe spacer
Time frame: 1 week, 3 weeks, and 5 weeks after surgery
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Background: PubMed 25441855Pentikainen 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.
- Background: PubMed 38896537Choo 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.
- Background: PubMed 16221466Saragas 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.
- Background: PubMed 31997741Hester 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.
- Background: PubMed 20868524Nix 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because this is a small, single-center study involving identifiable clinical and imaging data that cannot be fully anonymized while maintaining scientific value. Only aggregated results will be published in peer-reviewed journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Centre Assal de médecin et chirurgie du pied
Geneva, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom 3D-printed toe spacer and Standard folded-gauze toe spacer in people with Hallux Valgus, run by Centre Assal for Foot Medicine and Surgery SA at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient tolerance to postoperative toe spacer (time frame: 1 week, 3 weeks, and 5 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07267156, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.