Functional Outcomes Following Ankle Fracture Fixation With or Without Ankle Arthroscopy: Randomized Control Study
| Registry | NCT06086223 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 176 (Estimated) |
| Sponsor | Assiut University (Other) |
| Conditions | Ankle Fractures, Ankle Injuries, Arthroscopic Surgery |
| Interventions | ankle arthroscopy with ORIF, fracture ankle fixation without ankle arthroscopy (Procedure) |
| Dates | start 2023-11-01 (estimated), primary completion 2025-08-01 (estimated), completion 2026-07-30 (estimated), first posted 2023-10-17, last updated 2023-10-17 |
Related Papers Related Patents Related Grants Related Experts
All trials for Ankle Fractures All trials for Ankle Injuries All trials of ankle arthroscopy with ORIF All trials of fracture ankle fixation without ankle arthroscopy
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.
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 .
| Arm | Type | Interventions | Description |
|---|---|---|---|
| those patients who will go for ORIF plus arthroscopy | Experimental | Procedure: ankle arthroscopy with ORIF | we will start with a standard ankle arthroscopy. A leg holder and ankle joint distractor will be used. We will start with the anteromedial portal and introduce the 4-mm scope into the ankle joint. Next, under direct visualization, and taking care to preserve any branches of the superficial peroneal nerve, we will perform the anterolateral portal. We will carry out a standard diagnostic ankle arthroscopy to evaluate the ankle cartilage, wash intra-articular haematoma, identify, and remove any intra-articular fracture fragments and loose bodies, perform dynamic ligamentous stress examinations while directly visualizing the syndesmosis, the deltoid ligament, and the lateral collateral ligament. Following fracture fixation, arthroscopy will be also used as a second look to evaluate the quality of both articular and syndesmotic reduction, perform any needed arthroscopic intervention for deltoid ligament injury or management of chondral lesions (OCLs) |
| patients who will go for ORIF without arthroscopy | Experimental | Procedure: fracture ankle fixation without ankle arthroscopy | * Posterior malleolus fractures will be addressed when it is present whatever its size. * The fibula fractures will be fixated using either a posterolateral or direct lateral incision. Lag screws will be used when the fracture pattern allows, and all fractures will be also treated with a neutralization or antiglide plate depending on the pattern and approach. * If a medial malleolus fracture is present, this will be addressed through a direct medial incision. These fractures will be either fixed with cannulated screws or tension band cerclage wiring or a plate and screw construct depending on the fracture pattern. * Once all bony injuries will be stabilized, a Cotton test will be performed under live fluoroscopy to determine syndesmosis stability. If positive, the syndesmosis will be stabilized using fully threaded screws. |
Sex: All, ages: 16 Years to any
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