Deltoid Ligament Arthroscopic Repair in Ankle Fractures: Case Series

Ankle Fractures Clinical Trial

Official title:

Deltoid Ligament Arthroscopic Repair in Ankle Fractures: Case Series

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04473638
• Other study ID #: Arthroscopic_Deltoid_Fx_EPM
• Status: Completed
• Start date: August 1, 2019
• Est. completion date: July 10, 2021

Study information

• Verified date: July 2021
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 10, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fractures
• Ankle Injuries
• Deltoid Ligament; Sprain (Strain) (Ankle)
• Fractures, Bone
• Ligament Rupture
• Rupture
• Sprains and Strains

Intervention

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.

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual Analogue Scale (VAS)	Pain Score (0 to 10 | 10 worst score possible | 0 best score possible)	Time Frame: 6th post-operative month
Secondary	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