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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ankle Injuries; Ankle Fractures; Arthroscopic Surgery
• Intervention / Treatment: Procedure: ankle arthroscopy with ORIF; Procedure: fracture ankle fixation 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 Type: Interventional
• Enrollment (Estimated): 176
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: El-Taher Alaa Eldin Ahmed Eid, assisstant lecturer; Phone Number: 01004859149; Email: taheralaa92@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: those patients who will go for ORIF plus arthroscopy; we will start with a standard ankle arthroscopy. A leg holder and ankle joint distractor will be used. We will start with the anteromedial portal and introduce the 4-mm scope into the ankle joint. Next, under direct visualization, and taking care to preserve any branches of the superficial peroneal nerve, we will perform the anterolateral portal. We will carry out a standard diagnostic ankle arthroscopy to evaluate the ankle cartilage, wash intra-articular haematoma, identify, and remove any intra-articular fracture fragments and loose bodies, perform dynamic ligamentous stress examinations while directly visualizing the syndesmosis, the deltoid ligament, and the lateral collateral ligament. Following fracture fixation, arthroscopy will be also used as a second look to evaluate the quality of both articular and syndesmotic reduction, perform any needed arthroscopic intervention for deltoid ligament injury or management of chondral lesions (OCLs)	Procedure: ankle arthroscopy with ORIF; we will go for fixation of the fracture with association of scope intervention pre and post fixation; Other Names: ankle fracture fixation with arthroscopy
Experimental: patients who will go for ORIF without arthroscopy; Posterior malleolus fractures will be addressed when it is present whatever its size.; The fibula fractures will be fixated using either a posterolateral or direct lateral incision. Lag screws will be used when the fracture pattern allows, and all fractures will be also treated with a neutralization or antiglide plate depending on the pattern and approach.; If a medial malleolus fracture is present, this will be addressed through a direct medial incision. These fractures will be either fixed with cannulated screws or tension band cerclage wiring or a plate and screw construct depending on the fracture pattern.; Once all bony injuries will be stabilized, a Cotton test will be performed under live fluoroscopy to determine syndesmosis stability. If positive, the syndesmosis will be stabilized using fully threaded screws.	Procedure: fracture ankle fixation without ankle arthroscopy; we will go for fixation of the fracture alone with no scope intervention; Other Names: ankle fracture fixation without arthroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: October 7, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: functional outcomes of ankle fracture management; ankle scope; syndesmosis reduction; ankle ligaments evaluation
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Ankle Injuries; Ankle Fractures
• Other Study ID Numbers: Arthroscopy for ankle fracture

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No