Deltoid Ligament Arthroscopic Repair in Ankle Fractures: Case Series

NCT04473638 | Completed

• 1 other identifier: Arthroscopic_Deltoid_Fx_EPM
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ankle Injuries; Ankle Fractures; Deltoid Ligament; Sprain (Strain) (Ankle); Ligament Rupture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Visual Analogue Scale (VAS)

  Time Frame: 6th post-operative month

• Number of Complications related to Treatment

  6th post-operative month

Study Arms (1)

Arthroscopic

Deltoid Arthroscopic Repair in Ankle Fractures

Procedure: Arthroscopic Deltoid Repair

Interventions

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.

Arthroscopic

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Tertiary/Quaternary hospital patients

You may qualify if:

• \- 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

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04022-001, Brazil

Location

MeSH Terms

Conditions

Ankle Injuries; Ankle Fractures; Sprains and Strains

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Nacime Salomão Barbachan Mansur, MD, PhD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 16, 2020
• Study Start: August 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: July 10, 2021
• Last Updated: July 19, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After article publication.
• Access Criteria: A formal requisition will be needed, directly addressed to the main researcher. A good scientific reason must be included.

Locations

BR (1)