Functional Outcomes Following Ankle Fracture Fixation With or Without Ankle Arthroscopy

Ankle Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06086223
• Other study ID #: Arthroscopy for ankle fracture
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: July 30, 2026

Study information

• Verified date: October 2023
• Source: Assiut University
• Contact: El-Taher Alaa Eldin Ahmed Eid, assisstant lecturer
• Phone: 01004859149
• Email: taheralaa92[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 176
• Est. completion date: July 30, 2026
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fractures
• Ankle Injuries
• Arthroscopic Surgery
• Fractures, Bone

Intervention

Procedure:
• ankle arthroscopy with ORIF
we will go for fixation of the fracture with association of scope intervention pre and post fixation
• fracture ankle fixation without ankle arthroscopy
we will go for fixation of the fracture alone with no scope intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

Smith KS, Drexelius K, Challa S, Moon DK, Metzl JA, Hunt KJ. Outcomes Following Ankle Fracture Fixation With or Without Ankle Arthroscopy. Foot Ankle Orthop. 2020 Mar 2;5(1):2473011420904046. doi: 10.1177/2473011420904046. eCollection 2020 Jan. — View Citation

Zengerink M, Struijs PA, Tol JL, van Dijk CN. Treatment of osteochondral lesions of the talus: a systematic review. Knee Surg Sports Traumatol Arthrosc. 2010 Feb;18(2):238-46. doi: 10.1007/s00167-009-0942-6. Epub 2009 Oct 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American Orthopaedic Foot and Ankle Society(AOFAS) hindfoot score	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	6 months and one year follow up