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Trials / Not Yet Recruiting

Not Yet RecruitingNCT06086223

Functional Outcomes Following Ankle Fracture Fixation With or Without Ankle Arthroscopy

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
176 (estimated)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

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 .

Conditions

Interventions

TypeNameDescription
PROCEDUREankle arthroscopy with ORIFwe will go for fixation of the fracture with association of scope intervention pre and post fixation
PROCEDUREfracture ankle fixation without ankle arthroscopywe will go for fixation of the fracture alone with no scope intervention

Timeline

Start date
2023-11-01
Primary completion
2025-08-01
Completion
2026-07-30
First posted
2023-10-17
Last updated
2023-10-17

Source: ClinicalTrials.gov record NCT06086223. Inclusion in this directory is not an endorsement.