Deltoid Ligament Arthroscopic Repair in Ankle Fractures: Case Series

Completed

• Conditions: Ankle Injuries; Ligament Rupture; Deltoid Ligament; Sprain (Strain) (Ankle); Ankle Fractures
• Interventions: Procedure: Arthroscopic Deltoid Repair

• Registration Number: NCT04473638
• Lead Sponsor: Federal University of São Paulo

Brief Summary

To demonstrate the functional results of patients with ankle fractures operated with arthroscopic deltoid repair.

Detailed Description

Introduction: The diagnosis and treatment of ankle medial ligament lesions in malleolar fractures have always been surrounded by controversies. Even in the certainty of deltoid involvement and its consequent instability, the direct repair of this structure is not a consensus. In recent years, the arthroscopic technique to approach this ligament has been described with the objective of potentiating clinical results and minimizing possible complications.

Objective: To demonstrate the functional results of patients with ankle fractures operated with arthroscopic deltoid repair.

Methods: This is a retrospective study in patients diagnosed with ankle fractures associated with acute deltoid injuries and submitted to a malleolar fixation and deltoid arthroscopic repair between January 2018 and January 2020. All patients will fill an epidemiological questionnaire and will be evaluated for pain and function according to the Visual Analogue Scale (VAS) and the American Orthopaedic Foot and Ankle Society Score (AOFAS) at 12 months (6-24 months) average of follow-up.

Discussion: The inclusion of the deltoid complex and the low invasiveness of this technique can improve the clinical outcomes of these patients. Additional studies, with a prospective and comparative methodology are required to sustain this proposal.

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-13
• Study First Posted: 2020-07-16
• Primary Completion: 2020-11-01
• Status Verified: 2021-07
• Study Completion: 2021-07-10
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• acute (less than two weeks) ankle fracture containing a medial ligament injury suspicion will be included. Syndesmotic lesion with a deltoid association will also be addressed

Exclusion Criteria

• previous surgery
• autoimmune diseases
• neuropathy
• inflammatory diseases
• radiographic preoperative findings of ankle arthritis
• open medial wound
• coagulopathies
• any other condition that would contraindicate surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arthroscopic	Arthroscopic Deltoid Repair	Deltoid Arthroscopic Repair in Ankle Fractures

Primary Outcome Measures

Name	Time	Method
American Orthopedic Foot and Ankle Society - Hindfoot Score (AOFAS)	Time Frame: 6th post-operative month	Functional Score (0 to 100 \| 100 best score possible \| 0 worst score possible)

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	Time Frame: 6th post-operative month	Pain Score (0 to 10 \| 10 worst score possible \| 0 best score possible)
Number of Complications related to Treatment	6th post-operative month	Complications were established as dehiscence, neural damage, infection, and re-rupture. Dehiscence was set inability to heal the soft tissue coverage until the end of the 4th post-operative week. Peripherical nerve damage defined as hypoesthesia or paresthesia not solved until the end of the 6th month after the surgery. Infection termed as clinical signs infection or pus drainage at the wound that required the use of antibiotics. Re-rupture classified as an ankle sprain event during the follow-up.

Trial Locations

Locations (1)

Federal University of Sao Paulo; 🇧🇷 Sao Paulo, SP, Brazil