Functional Outcomes Following Ankle Fracture Fixation With or Without Ankle Arthroscopy

Not Applicable

Not yet recruiting

• Conditions: Arthroscopic Surgery; Ankle Fractures; Ankle Injuries

• Registration Number: NCT06086223
• Lead Sponsor: Assiut University

Brief 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 .

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-07
• Study First Submitted QC: 2023-10-13
• Last Update Submitted: 2023-10-13
• Study First Posted: 2023-10-17
• Last Update Posted: 2023-10-17
• Study Start: 2023-11-01
• Primary Completion: 2025-08-01
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 176

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
American Orthopaedic Foot and Ankle Society(AOFAS) hindfoot score	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