A Study to Compare Two Different Managements After Ankle Surgery: Immediate and Delayed Weight-bearing.

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.

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.

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.

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.

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.

measured from the day of surgery (Day 1) to 2, 6, 12 and 24 weeks postoperatively by a using the SF-36 questionnaire.

The SF-36 is a validated, self-administered questionnaire specifically designed for evaluating patient health-related quality of life. It comprises of 36 questions, relating to eight key areas of physical and psychological health, including vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. The weighted-score of each area is transformed into a 0-100 scale, with lower scores indicating the more disability and higher scores the less disability.

A negative change from the day of surgery to week 2, 6, 12 or 24 will indicate an improvement in SF-36 score and, therefore, in quality of life.

evaluated by using the Tegner score at 12 and 24 weeks postoperatively. The Tegner activity level scale is a patient-administered rating system designed to provide a standardized method of grading work and sporting activities. It consists of a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury. The score varies from 0 that represents sick leave or disability pension because of ankle problems to 10 that corresponds to participation in national and international elite competitive sports.

The Tegner activity level scale questionnaire will be administered at week 12 (visit 4) and 24 (visit 5).

A positive change from score before injury to post-operative score will indicate an improvement in Tegner activity level scale score and, therefore, a higher level of activity and return to previous daily activity.

evaluated through gait analysis by using the OptoGait® at 6, 12, 24 weeks postoperatively.

The OptoGait® is an avant-garde laser and video technology that permits to quantitatively measure through a sophisticated software the symmetry of the steps, the weight-bearing area, the time of foot-rest on the ground and other parameters. The change of each of this parameter will be evaluated at week 6 (visit 3), 12 (visit 4), 24 (visit 5) to assess the ankle functional recovery during the rehabilitation intervention.

measured through the Ankle Range of Motion (ROM) assessed with a goniometer at 6, 12, 24 weeks postoperatively.

Objective activity level will be continuously documented through a wrist activity tracker measuring daily walking distance up to 24 weeks. The patient will receive the tracker after the surgery and wear it for 24 weeks. The tracker, then, will be returned to the hospital during visit 5.

Standard X-ray assessment to determine healing, hardware fixation, fracture alignment, fracture reduction, implants mobilization will be performed at week 6 (visit 3), 12 (visit 4), 24 (visit 5). X-ray at 24 weeks will be done only in case of fracture non-union reported at the 12-weeks post-operatively.

Pain drug consumption will be assessed by recording in a patient diary type and dosage of pain drugs, and reason for taking the drug from surgery (day 1, visit 1) up to 24 weeks (visit 5) postoperatively.

Drug consumption will be quantified in milligrams of active principle taken per week and in number of days in which the patient required a pain drugs during the study period.

Patient satisfaction will be documented by using 0-10 NRS administered at 6, 12, 24 weeks postoperatively. The satisfaction NRS is a self-assessment scale in which patients rate their satisfaction on an 11-point numerical scale from 0 (completely dissatisfied) to 10 (completely satisfied). The satisfaction NRS will be administered after surgery (visit 1, day 1) and at week 6 (visit 3), 12 (visit 4) and 24 (visit 5).

A positive change from the day of surgery to week 6, 12 or 24 will indicate an improvement in satisfaction NRS score and, therefore, in patient satisfaction.

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.