Comparing weight-bearing methods after foot surgery for bunions
Is Full Weight Bearing After the Modified Lapidus Operation Possible? A Randomized Controlled Trial to Compare Early and Partial Weight-bearing
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Ente Ospedaliero Cantonale, Bellinzona Academic / other |
| Locations | 1 site (Lugano) |
| Trial ID | NCT05534724 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for modified Lapidus arthrodesis with or without additional surgical procedures on the foot.
Not a fit: Patients with diabetes, rheumatoid arthritis, or those who have had previous foot surgeries may not benefit from this study.
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 performed: While similar studies have explored post-operative management in foot surgeries, this specific comparison of weight-bearing methods is relatively novel.
Eligibility criteria
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 this trial is running
Lugano
- Eoc — Lugano, Switzerland (Recruiting)
Study contacts
- Principal investigator: Martin Riegger, MD — Eoc
- Study coordinator: Martin Riegger, MD
- Email: RicercaOrtopedia.ORL@eoc.ch
- Phone: 0041918117029
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.