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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
122
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
EOC
Lugano, Switzerland
RECRUITINGSubjective 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.
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Time frame: at 12 and 24 weeks