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NCT Number: NCT06086223

Functional Outcomes Following Ankle Fracture Fixation With or 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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ankle arthroscopy with ORIF

Procedure

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

Other names: ankle fracture fixation with arthroscopy

fracture ankle fixation without ankle arthroscopy

Procedure

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

Other names: ankle fracture fixation without arthroscopy

Primary outcomes

  1. American Orthopaedic Foot and Ankle Society(AOFAS) hindfoot score

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

El-Taher Alaa Eldin Ahmed Eid, assisstant lecturer

CONTACT

[email protected]

01004859149

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Functional Outcomes Following Ankle Fracture Fixation With or Without Ankle Arthroscopy: Randomized Control Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 17, 2023
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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