Functional Outcomes Following Ankle Fracture Fixation With or Without Ankle Arthroscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-07-30

Brief Summary

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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.

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Detailed Description

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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 .

Conditions

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Ankle Fractures Ankle Injuries Arthroscopic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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those patients who will go for ORIF plus arthroscopy

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)

Group Type EXPERIMENTAL

ankle arthroscopy with ORIF

Intervention Type PROCEDURE

we will go for fixation of the fracture with association of scope intervention pre and post fixation

patients who will go for ORIF without 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.

Group Type EXPERIMENTAL

fracture ankle fixation without ankle arthroscopy

Intervention Type PROCEDURE

we will go for fixation of the fracture alone with no scope intervention

Interventions

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ankle arthroscopy with ORIF

we will go for fixation of the fracture with association of scope intervention pre and post fixation

Intervention Type PROCEDURE

fracture ankle fixation without ankle arthroscopy

we will go for fixation of the fracture alone with no scope intervention

Intervention Type PROCEDURE

Other Intervention Names

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ankle fracture fixation with arthroscopy ankle fracture fixation without arthroscopy

Eligibility Criteria

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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