Ankle Fractures, Ankle Injuries, Arthroscopic Surgery
Conditions
Keywords
functional outcomes of ankle fracture management, ankle scope, syndesmosis reduction, ankle ligaments evaluation
Brief summary
The aim of our study is to identify if there is statistically significant difference in patient reported functional outcomes in cases of unstable ankle fracture managed by ORIF with and without ankle arthroscopy.
Detailed description
Acute ankle fracture is one of the commonest fractures of the lower limb. Anatomical reduction and stable fixation remain the main surgical treatment for unstable ankle fractures . However, its final outcomes are not as good as expected . Fracture malunion, failure to address the disrupted syndesmosis and associated ligamentous or chondral lesions can be reasons for poor surgical outcome. 1-mm of lateral talar shift lead to a 42% increase in contact stress, so the anatomic reduction is critical to the long-term integrity of the joint . It is difficult to assess 1 to 2 mm of mal-reduction with C-arm fluoroscopy. The best assessment of the syndesmotic reduction is performed with axial CT imaging of the ankle. Ankle arthroscopy is expected to be a more sensitive tool for syndesmotic disruption diagnosis and other intra-articular pathologies and as a guide for anatomical reduction of the syndesmosis . Several studies have reported the incidence of chondral lesions seen during ankle arthroscopy at the time of ankle fracture ORIF, but those studies report the role of arthroscopy as a diagnostic or predictive tool for patient outcome. Very few studies have discussed the rates of arthroscopic intervention, the procedures performed, and the association of these procedures with patient final functional outcomes .
Interventions
we will go for fixation of the fracture with association of scope intervention pre and post fixation
we will go for fixation of the fracture alone with no scope intervention
Sponsors
Study design
Masking description
Random assignment of intervention will be done after subjects have been assessed for eligibility and recruited. The sealed opaque envelope method will be used for randomization.
Intervention model description
Based on determining outcome variable, the estimated minimum required sample size is 176 cases (88 cases in each group). The sample size was calculated using G\*power software 3.1.9.7., based on the following assumptions: the patient satisfaction rate was higher in those patients who underwent arthroscopy compared with ORIF alone (93% vs 75%, P ¼ .05) (5). Main statistical test is z test, Alpha = 0.05, Power = 0.95 Allocation ratio= 1.
Eligibility
Inclusion criteria
* Patients ≥16 years of age who will be managed operatively for: * rotational ankle fracture Danis-Weber classification B or C fibula fracture * fracture dislocation ankle * Fractures extending into the tibial plafond, * Talus fractures (body or neck) in our institution
Exclusion criteria
Pediatric fractures, Polytrauma patients, Fractures managed with closed-contact casting and, patients with lost follow up during this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Orthopaedic Foot and Ankle Society(AOFAS) hindfoot score | 6 months and one year follow up | AOFAS hindfoot score difference between the 2 groups at 6 months and one year postoperatively from 0 to 100 where higher value indicates better functional outcomes |