A Study to Compare Early and Partial Weight-bearing After Hallux Valgus Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorEnte Ospedaliero Cantonale, Bellinzona
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Diabetes mellitus
Rheumatoid arthritis
Previous foot surgery
Classic Lapidus surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Partial weight-bearing (10 - 15kg)
Other interventionImmediate post-operative partial weight-bearing (10 - 15kg) with a VACOPASO shoe for 6 weeks
Complete weight-bearing
Other interventionComplete post-operative weight-bearing with a VACOPASO shoe for 6 weeks
Treatment groups
122 Participants
are divided into 2 treatment groupsGroup A: Partial weight-bearing (10 - 15kg)Other 1 intervention
Group B: Complete weight-bearingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 weeksSecondary outcomes
1
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.2
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 postoperatively3
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 weeks4
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov