Deltoid Ligament Arthroscopic Repair in Ankle Fractures: Case Series

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

Study Overview

• Status: Completed
• Conditions: Ankle Injuries; Ankle Fractures; Ligament Rupture; Deltoid Ligament; Sprain (Strain) (Ankle)
• Intervention / Treatment: Procedure: 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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 04022-001
      • Federal University of São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Tertiary/Quaternary hospital patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Arthroscopic; Deltoid Arthroscopic Repair in Ankle Fractures

Procedure: Arthroscopic Deltoid Repair; . A 4.5 mm arthroscopic set was used to clean the joint and assess medial and associated injuries. After deltoid injury confirmation through the method already mentioned, the medial gutter was prepared. The ideal positioning for the bone anchor in the medial malleolus followed Vega's recommendations and was located in the inferolateral quadrant created by the intersection of two lines: (1) tibia-talar joint line and (2) tangent line to the medial malleolus joint surface.(14). Sutures were passed respecting the safe zone illustrated by Acevedo at al, at the area between the posterior tibial tendon and the saphenous vein (16-25mm) (15). Sutures were passed but not tightened.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS)	Pain Score (0 to 10 | 10 worst score possible | 0 best score possible)	Time Frame: 6th post-operative month
Number of Complications related to Treatment	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.	6th post-operative month

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Investigators: Principal Investigator: Nacime Salomão Barbachan Mansur, MD, PhD, Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): July 10, 2021

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 16, 2020

Study Record Updates

• Last Update Posted (Actual): July 19, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Rupture; Fractures, Bone; Sprains and Strains; Ankle Injuries; Ankle Fractures
• Other Study ID Numbers: Arthroscopic_Deltoid_Fx_EPM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the ICMJE data sharing police, core records will be shared at an online depository and available upon request.
• IPD Sharing Time Frame: After article publication.
• IPD Sharing Access Criteria: A formal requisition will be needed, directly addressed to the main researcher. A good scientific reason must be included.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

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