The investigators will compare two types of rehabilitation in patients who undergo a surgery for treatment of malleolar fractures: immediate complete weight-bearing and delayed weight-bearing.
The investigators want to evaluate if the immediate complete weight-bearing can improve and hasten the functional outcome of the ankle without increasing the risk of complications.
Male and female adults
Age ranging from 18 to 70 years, included
Signed Informed Consent
Ankle fracture requiring surgical management classified as:1- Weber A fracture pattern (AO 44.A1, 44.A2, 44.A3) with or without association with a medial or posterior lesion/fracture or 2- Weber B fracture pattern (AO 44.B1, 44.B2, 44.B3) with or without association with a medial or posterior lesion/fracture
Weber C fracture pattern
Bilateral fractures or fractures in other locations
Maissoneauve associated lesion
Body Mass Index < 18.5 and ≥ 30
Parallel
immediate post-operative complete weight-bearing after surgery
Other interventionPatients randomized to the experimental post-operative rehabilitation intervention will undergo to immediate complete weight-bearing starting immediately after surgery. Immediate complete weight-bearing consists in the possibility to undergo all the everyday activities without limiting weight-bearing and without the use of walking aids. During the rehabilitation period, patients will wear an ankle brace (VACOankle® OPED); this will ensure the safety of the early recovery phases, protecting from dangerous movements while allowing the mobilization in the healthy range of movement.
delayed weight-bearing for 6 weeks after surgery
Other interventionPatients randomized to the control post-operative rehabilitation intervention will undergo to delayed weight-bearing starting at 6-weeks post-operatively. Delayed weight-bearing consists in the limitation of the weight-bearing to 20-30% of patient's total weight using crutches for the first 6 weeks after surgery. During the rehabilitation period, patients will wear an ankle brace (VACOankle® OPED).
change from day 1 after surgery in subjective functional ankle recovery on the Olerud-Molander Ankle Score at week 6
Functional ankle recovery is measured using the Olerud-Molander Ankle Score (OMAS)- The OMAS is a validated, self-administered patient questionnaire designed to subjectively evaluate ankle function after fracture. The scale is an ordinal functional rating scale based on nine different items given different points. The total score is calculated as the sum of each rated item and range from 0 points (totally impaired function) to 100 points (completely unimpaired function). The OMAS questionnaire will be administered after surgery (visit 1, day 1) and at week 6 (visit 3). A negative change from the day of surgery to week 6 will indicate an improvement in OMAS score and, therefore, in functional ankle recovery.
change in subjective functional ankle recovery on the Olerud-Molander Ankle Score during the first 24 weeks after surgery
measured using the OMAS score at 2, 12 and 24 weeks postoperatively. measured using the Olerud-Molander Ankle Score (OMAS)- The OMAS is a validated, self-administered patient questionnaire designed to subjectively evaluate ankle function after fracture. The scale is an ordinal functional rating scale based on nine different items given different points. The total score is calculated as the sum of each rated item and range from 0 points (totally impaired function) to 100 points (completely unimpaired function). The OMAS questionnaire will be administered after surgery (visit 1, day 1) and at week 2 (visit 2), 12 (visit 4) and 24 (visit 5). A negative change from the day of surgery to week 2, 12 or 24 will indicate an improvement in OMAS score and, therefore, in functional ankle recovery.
Change form day of surgery in functional ankle disability on the Foot and Ankle Disability Index (FADI) during the first 24 weeks after surgery
measured using the Foot and Ankle Disability Index (FADI) at 2, 6, 12 and 24 weeks postoperatively. FADI is designed to assess functional limitations related to foot and ankle conditions. FADI consists of 4 pain-related and 22 activity-related items) for a total of 26. Each of the 22 activity-related items is scored on a 5-point Likert scale from 0 (unable to do) to 4 (no difficulty at all). The 4 pain-items are scored from 0 (none) to 4 (unbearable). The total FADI score is calculated as percentages, with 100% representing no ankle dysfunction. The FADI questionnaire will be administered after surgery (visit 1, day 1) and at week 2, (visit 2), 6 (visit 3), 12 (visit 4) and 24 (visit 5). A positive change from the day of surgery to week 2, 6, 12 or 24 will indicate an improvement in FADI score and, therefore, in functional ankle disability.
Change form baseline in pain on the Numerical Rating Scale (NRS)
measured by using a Numerical Rating Scale (NRS) at 12 and 24 weeks postoperatively. The pain NRS is a self-assessment scale in which patients rate their pain on an 11-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). The pain NRS will be administered after surgery (visit 1, day 1) and at 12 (visit 4) and 24 (visit 5). A negative change from the day of surgery to week 12 or 24 will indicate an improvement in pain NRS score and, therefore, in local pain.
Daily pain and function
monitored through mobile NRS application up to 12 weeks postoperatively. A new application suitable for the use with both Android and iOS running mobile phones was developed by our Institution (EOC- Ente Osedaliero Cantonale) , namely "EOC - EMApp". The application asks the patients two simple questions: to rate actual pain and function on a 0-10 NRS two times daily at random hours in the morning and the evening, as suggested by previous experiences. The following parameters will be calculated and compared between groups: average daily pain and function, mean value of pain and function for each week and for the entire period of assessment (12 weeks). If the patient does not have a smartphone, he/she will not be included it in this assessment group.
Number of Participants With Treatment-Related Adverse Events as Assessed by the Clavien-Dindo classification.
The safety will be evaluated by documenting the incidence, nature and severity of all (serious) adverse events / post-operative complications that may in any way be related to the surgical procedure. In particular, wound complications, mal-union or non-union, fracture displacement, hardware failure requiring re-operations will be assessed. Incidence, nature and severity of all serious and adverse events / complications will be recorded. Severity will be assessed using the Clavien-Dindo classification.
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