Deltoid Ligament Arthroscopic Repair in… | Clinical Trial

Key information

Conditions

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

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Federal University of Sao Paulo

São Paulo, 04022-001, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroscopic Deltoid Repair

Procedure

. 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.

Primary outcomes

American Orthopedic Foot and Ankle Society - Hindfoot Score (AOFAS)

Time frame: Time Frame: 6th post-operative month

Functional Score (0 to 100 | 100 best score possible | 0 worst score possible)

Secondary outcomes

Visual Analogue Scale (VAS)

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2021
First posted: Jul 16, 2020
Registry last updated: Jul 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed