A scoring scale for symptom evaluation after ankle fracture.
C Olerud, H Molander
https://pubmed.ncbi.nlm.nih.gov/6437370Actively Recruiting
Phase Not Applicable
Age: 18Years - 85Years
All Genders
Healthy Volunteers
ID05534724
Is Full Weight Bearing After the Modified Lapidus Operation Possible? A Randomized Trial Comparing Early and Partial Weight-bearing After Hallux Valgus Surgery
Led by Ente Ospedaliero Cantonale, Bellinzona · Updated on 2025-08-06
122
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating post-operative management approaches after a modified Lapidus arthrodesis surgery for hallux valgus, with or without additional surgeries such as Akin or Weil/Hohmann procedures. The study aims to compare the effectiveness and safety of immediate full weight-bearing versus partial weight-bearing (10-15 kg) during rehabilitation. This randomized controlled trial explores a new rehabilitation method following foot surgery to improve recovery. Participants will be randomly assigned to one of two groups after surgery: one group will follow partial weight-bearing with a specialized VACOPASO shoe and use crutches along with antithrombotic medication for 6 weeks, while the other group will have immediate complete weight-bearing with the same shoe and medication for the same period. The surgical operation follows standard clinical practices for hallux valgus correction. During the study, healing progress will be monitored through standard X-rays at 6, 12, and 24 weeks to check bone healing, hardware fixation, and fracture alignment. Pain will be measured using a Visual Analogue Scale at the day of surgery and at follow-up visits. Quality of life and functional recovery will be assessed through established foot and ankle scoring systems at multiple time points. The main outcome is the subjective functional recovery measured by the Olerud and Molander Ankle Score at 6 weeks post-surgery.
CONDITIONS
Brief Title
A Study to Compare Early and Partial Weight-bearing After Hallux Valgus Surgery
Who Can Participate
Age: 18Years - 85Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Patient who undergo modified Lapidus arthrodesis operation
- Additional surgeries like Akin or Weil/Hohmann procedures on the foot
- Willingness and ability to participate in the trial
- Signed informed consent
You will not qualify if you...
- Diabetes mellitus
- Rheumatoid arthritis
- Previous foot surgery
- Classic Lapidus surgery
- Inability to follow study procedures due to language, psychological, physical, or cognitive issues
- Inability or contraindication to undergo the study interventions
- Pregnant women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - 6 weeks
Participants undergo the modified Lapidus operation with or without additional foot surgeries. Post-operatively, participants are randomized to either partial weight-bearing or full weight-bearing while wearing a VACOPASO shoe for 6 weeks.
1 surgery visit and weekly follow-up visits during 6 weeks
Post-operative Follow-up
Duration - Up to 18 weeks after surgery (from week 6 to week 24)
Participants are monitored through scheduled assessments including pain measurement, quality of life questionnaires, functional recovery scores, and standard X-ray evaluations to assess healing and hardware fixation.
Visits at 6, 12, and 24 weeks post-surgery
Trial Site Locations
Total: 1 location
1
EOC
Lugano, Switzerland, 6900
Actively Recruiting
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Research Team
M
Martin Riegger, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
A quarter of a century of experience with the operative correction of the metatarsus varus primus in hallux valgus.
P W LAPIDUS
https://pubmed.ncbi.nlm.nih.gov/13413410A modification of the Lapidus operation for hallux valgus.
A R Butson
https://pubmed.ncbi.nlm.nih.gov/6997319Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes.
H B Kitaoka, I J Alexander, R S Adelaar...
https://pubmed.ncbi.nlm.nih.gov/7951968Stability of Locking Plate and Compression Screws for Lapidus Arthrodesis: A Biomechanical Comparison of Plate Position.
David Drummond, Travis Motley, Victor Kosmopoulos...
https://pubmed.ncbi.nlm.nih.gov/29472168Biomechanical analysis of the first metatarsocuneiform arthrodesis.
R G Ray, R P Ching, J C Christensen...
https://pubmed.ncbi.nlm.nih.gov/9798168Modified Lapidus procedure for hallux valgus.
B J Sangeorzan, S T Hansen
https://pubmed.ncbi.nlm.nih.gov/2744666Metatarsocuneiform arthrodesis for management of hallux valgus and metatarsus primus varus.
M Myerson, S Allon, W McGarvey
https://pubmed.ncbi.nlm.nih.gov/1601337Modified lapidus procedure for the treatment of hypermobile hallux valgus.
P A Bednarz, A Manoli
https://pubmed.ncbi.nlm.nih.gov/11128011Lapidus bunionectomy: Early evaluation of crossed lag screws versus locking plate with plantar lag screw.
Amol Saxena, Aidan Nguyen, Elise Nelsen
https://pubmed.ncbi.nlm.nih.gov/19232969