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Clinical Trials/NCT06086223
NCT06086223Not yet recruitingNot Applicable

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

Assiut University0 sites176 target enrollmentStarted: November 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
176
Primary Endpoint
American Orthopaedic Foot and Ankle Society(AOFAS) hindfoot score

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

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.

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

El-Taher Alaa Eldin Ahmed Eid

Principle investigator

Assiut University

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