Comparing weight-bearing methods after foot surgery for bunions
Official title: Is Full Weight Bearing After the Modified Lapidus Operation Possible? A Randomized Controlled Trial to Compare Early and Partial Weight-bearing
Run by Ente Ospedaliero Cantonale, Bellinzona · NCT05534724 · Data updated 2026-11-12
This study is testing whether letting patients put some weight on their foot or allowing them to walk normally after bunion surgery helps them heal better and feel less pain.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 122 (estimated) |
| Sponsor | Ente Ospedaliero Cantonale, Bellinzona Academic / other |
| Locations | 1 site (Lugano) |
| Status | Recruiting |
| Started | January 19, 2023 |
| Main results expected | July 1, 2028 |
| Study ends | July 1, 2028 |
| Registry record updated | September 11, 2026 |
| Trial ID | NCT05534724 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients scheduled for modified Lapidus arthrodesis with or without additional surgical procedures on the foot.
✕Probably not a fit
Patients with diabetes, rheumatoid arthritis, or those who have had previous foot surgeries may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness and safety of two different post-operative management strategies following modified Lapidus arthrodesis for hallux valgus. Patients will be randomly assigned to either a partial weight-bearing group (limited to 10-15kg) or a complete weight-bearing group for six weeks. The study will assess healing through X-ray evaluations and measure pain severity and quality of life using standardized scoring systems at multiple time points post-surgery. The goal is to determine which approach leads to better recovery outcomes.
Why it matters
Potential benefit: If successful, this study could improve recovery protocols and enhance quality of life for patients undergoing bunion surgery.
How similar studies have gone: While similar studies have explored post-operative management in foot surgeries, this specific comparison of weight-bearing methods is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient who undergo modified Lapidus arthrodesis operation and associated with: * Additional surgical gestures such as e.g. interventions on the proximal phalanx of the first finger (Akin) or interventions on the 2nd and / or 3rd ray (Weil / Hohmann) \[23,24\]. * Willingness and ability to participate in the trial * Signed Informed Consent Exclusion Criteria: * Diabetes mellitus * Rheumatoid arthritis * Previous foot surgery * Classic Lapidus surgery * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, general physical problem of the participant, etc. * Inability or contraindications to undergo the investigated intervention * Pregnant women
Where it's running
-
Eoc
Lugano, Switzerland Recruiting
Study contacts
- Principal investigator: Martin Riegger, MD — Eoc
- Study coordinator: Martin Riegger, MD
- Email: RicercaOrtopedia.ORL@eoc.ch
- Phone: 0041918117029
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Constipation Prevention Checklist in hip surgery patients
A simple checklist is used to see if hip surgery patients can stay regular by staying hydrated, eating well, moving early, and using abdominal massage.
-
Self-rehabilitation after foot surgery with a connected app
This study tests whether a connected rehabilitation app can help adults after hallux valgus surgery improve ankle and toe mobility at home.
-
Sciatic nerve block with extended-release bupivacaine (ALX006) for bunion surgery
This will test whether a single-dose extended-release bupivacaine (ALX006) given as a sciatic nerve block reduces pain after bunion surgery in adults.
-
VIRTUGUIDE System with DePuy Synthes Lapidus Implant for Hallux Valgus
This study tests how well the VIRTUGUIDE System with a compatible DePuy Synthes Lapidus implant works for people undergoing a primary Lapidus procedure to correct hallux valgus.
-
One versus two Kirschner wires for minimally invasive correction of severe hallux valgus
This trial tests whether adding a second Kirschner (K-) wire during minimally invasive bunion surgery helps people with severe hallux valgus keep their toe alignment and have fewer complications.
-
Custom 3D-printed toe spacer for bunion (hallux valgus) surgery recovery
This will test whether a custom 3D-printed toe spacer is more comfortable and better at keeping the big toe aligned than a standard folded-gauze spacer for adults after hallux valgus surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.