Immediate vs Delayed Weight-bearing After Surgical Treatment of Malleolar Fractures: a Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Lateral Malleolus Fracture
- Sponsor
- Ente Ospedaliero Cantonale, Bellinzona
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- change from day 1 after surgery in subjective functional ankle recovery on the Olerud-Molander Ankle Score at week 6
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
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.
Detailed Description
The study population corresponds to the patients who may benefit from a post-operative rehabilitation protocol with immediate weight-bearing. Eligible lateral malleolar fractures are limited to Weber A and Weber B fractures, since they have a higher stability, after open reduction and internal fixation, compared to Weber C and Maisonneuve fractures. This higher stability gives the possibility to evaluate the benefit of the immediate weight-bearing protocol without safety concerns. A power analysis was performed to estimate the required sample size to detect a significant difference in the OMAS score at 6 weeks between groups: the number of patients needed is 42 patients per group (84 patients overall) but, considering the risk of drop-outs, the investigators plan to enroll 20% more patients for a total of 100 patients. The surgical operation will be carried out following the AO Foundation general and specific rules concerning the surgical treatment of malleolar fractures . In particular,an anatomical open reduction and internal fixation with one or two compression screws sustained by a neutralization third-tubular plate for simple fractures or a bridging third-tubular locking compression plate for multi-fragmentary fractures will be performed. Postoperatively, patients who still meet the eligibility criteria will be randomized in 2 groups: immediate post-operative complete weight-bearing and complete weight-bearing delayed for 6 weeks.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 (patients will wear an ankle brace, 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 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 (also patients of the control group will wear the ankle brace). Subsequent follow-up visits are scheduled at 2, 6, 12 and 24 weeks after surgery. Patients with a fracture non-union radiologically confirmed at week 24 will be followed up until 48 weeks after surgery. Clinical assessments will be performed using subjective, objective and radiological evaluations. Safety will be monitored throughout the study. Overall study duration will be 2 years and 6 months (2 years to reach the expected sample size and 6 months to complete the follow-up):
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •Willingness and ability to participate in the trial
Exclusion Criteria
- •Weber C fracture pattern
- •Bilateral fractures or fractures in other locations
- •Maissoneauve associated lesion
- •Body Mass Index \< 18.5 and ≥ 30
- •Metabolic diseases influencing fracture healing processes
- •Medical comorbidities precluding operative intervention
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, general physical problem of the participant, etc.
- •Inability or contraindications to undergo the investigated intervention
- •Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
- •Pregnant women
Outcomes
Primary Outcomes
change from day 1 after surgery in subjective functional ankle recovery on the Olerud-Molander Ankle Score at week 6
Time Frame: baseline and 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.
Secondary Outcomes
- Change form baseline in pain on the Numerical Rating Scale (NRS)(baseline, 12 and 24 weeks)
- change in subjective functional ankle recovery on the Olerud-Molander Ankle Score during the first 24 weeks after surgery(baseline, week2, week 12 and week 24)
- Objective ankle functional recovery(6, 12, 24 weeks)
- Return to previous daily activities on the Tegner activity level scale(week 12 and week 24)
- Objective activity level(24 weeks)
- Change form day of surgery in functional ankle disability on the Foot and Ankle Disability Index (FADI) during the first 24 weeks after surgery(baseline, 2, 6, 12 and 24 weeks)
- Daily pain and function(12 weeks)
- Ankle joint flexibility(6, 12, 24 weeks)
- change in quality of life on the 36-Item Short Form Health Survey (SF-36 questionnaire).(baseline, 2, 6,12 and 24 weeks)
- Pain drug consumption(24 weeks)
- Patient satisfaction on the satisfaction Numerical Rating Scale (NRS scale)(day of surgery, week 6, 12 and 24)
- Radiological assessment(24 weeks)