An interventional study of Partial weight-bearing (10 - 15kg) and Complete weight-bearing in Hallux Valgus and Orthopedic Disorder, sponsored by Ente Ospedaliero Cantonale, Bellinzona. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Ente Ospedaliero Cantonale, Bellinzona · Not applicable, Interventional, and Treatment
This is a two-arm randomized controlled trial with the aim to evaluate the effectiveness and safety of post-operative management after a modified Lapidus arthrodesis with/without an Akin or a Weil/Hohmann surgery fusion with immediate complete weight-bearing compared with partial weight-bearing (10 - 15kg) for 6 weeks as a novel approach for rehabilitation after a foot surgery.
The surgical operation will be carried out according to the standard clinical practice, namely following the modified Lapidus general and specific rules concerning the surgical treatment of hallux valgus with/without an Akin or a Weil/Hohmann surgery fusion. Post-operatively, patients who meet the eligibility criteria will be randomized into one of the two groups (partial weight-bearing limited at 15kg vs full weight-bearing) Patient in both groups will be wearing a VACOPASO shoe for 6 weeks.
Standard X-ray assessment to determine healing, hardware fixation, fracture alignment, fracture reduction, implants mobilization will be performed at weeks 6, 12, 24.
Change in pain severity from the day of surgery to 6, 12 and 24 weeks postoperatively will be measured using the pain Visual Analogue Scale (VAS). Quality of life will be assessed through the American Orthopedic Foot and Ankle Score (AOFAS). Subjective functional recovery through the Olerud and Molander Ankle Score (OMAS).
157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.
This study's planned enrollment of 122 is above the median of 58 across 119 interventional studies indexed under Hallux Valgus.
Browse Hallux Valgus studies →Ente Ospedaliero Cantonale, Bellinzona is the lead sponsor of 38 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immediate post-operative partial weight-bearing (10 - 15kg) with a VACOPASO shoe for 6 weeks, crutches and antithrombotic prophylaxis
Other: Partial weight-bearing (10 - 15kg)
Immediate post-operative complete weight-bearing with a VACOPASO shoe for 6 weeks and antithrombotic prophylaxis
Other: Complete weight-bearing
Immediate post-operative partial weight-bearing (10 - 15kg) with a VACOPASO shoe for 6 weeks
Complete post-operative weight-bearing with a VACOPASO shoe for 6 weeks
Subjective functional recovery measured by Olerud and Molander Ankle Score (OMAS)
The Olerud and Molander Ankle Score (OMAS) is a functional rating scale from 0 to 100 and is based on nine different items: pain, stiffness, swelling, stair climbing, running, jumping, squatting, supports and activities of daily living. Higher scores mean a better outcome.
Time frame: at 6 weeks
Pain on a Visual Analogue Scale
Change in pain severity postoperatively measured using the pain Visual Analogue Scale (VAS). The pain VAS scale is a validated, self-assessment scale in which patients rate their pain by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain" (10).
Time frame: At the day of surgery, at 6, 12 and 24 weeks postoperatively.
Bone consolidation through anteroposterior and lateral foot x-rays
Incidence of bone consolidation (bone callus formation) assessed in an objective measure by the radiologist
Time frame: 6 weeks and 12 weeks. At 24 weeks in case of fracture non-union reported at the 12th week postoperatively
American Orthopedic Foot and Ankle Score questionnaire
The American Orthopedic Foot and Ankle Score (AOFAS) is used find the quality of life index for foot-and-ankle pathologies. It is made of nine questions and cover three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points. Higher scores mean a better outcome.
Time frame: at 6, 12 and 24 weeks
Subjective functional recovery measured by Olerud and Molander Ankle Score (OMAS)
Subjective functional recovery through the Olerud and Molander Ankle Score (OMAS). The Olerud and Molander Ankle Score (OMAS) \[7\] is a functional rating scale from 0 to 100 and is based on nine different items: pain, stiffness, swelling, stair climbing, running, jumping, squatting, supports and activities of daily living. Higher scores mean a better outcome.
Time frame: at 12 and 24 weeks
Started Jan 2023 (actual). Primary completion is estimated for Jul 2028, 65 months after the start.
Of 51 non-industry interventional studies with no phase under Hallux Valgus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 55. This study's planned 65 months is above that.
Counting every sponsor, half of 56 studies reached it within 26 months; a quarter within 11 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ente Ospedaliero Cantonale, Bellinzona