Functional Outcomes Following Ankle Fracture Fixation With or Without Ankle Arthroscopy

Assiut University

Status: Not yet enrolling

Conditions: Arthroscopic Surgery; Ankle Fractures; Ankle Injuries

Treatments: Procedure: fracture ankle fixation without ankle arthroscopy; Procedure: ankle arthroscopy with ORIF

Study type: Interventional

Funder types: Other

Identifiers

NCT06086223

Arthroscopy for ankle fracture

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 176 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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176 participants in 2 patient groups

those patients who will go for ORIF plus arthroscopy

Experimental group

Description:

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)

Treatment:

Procedure: ankle arthroscopy with ORIF

patients who will go for ORIF without arthroscopy

Experimental group

Description:

* 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.

Treatment:

Procedure: fracture ankle fixation without ankle arthroscopy