- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04459910
Medial and Lateral Combined Ligament Arthroscopic Repair for Multidirectional Ankle Instability: Case Series
Abstract Introduction: The high prevalence of sprains in the population has provided a substantial number of patients with lateral instability of the ankle. The continuity of this condition can lead to the progressive loosening of the medial containment structures, generating a multidirectional rotational instability. The deltoid approach through the imbrication of its components has been proposed as a solution for these patients. The arthroscopic technique has been described as an alternative.
Methods: This is a retrospective study with patients diagnosed with multidirectional instability and submitted to an ankle arthroscopy with medial repair (arthroscopic tensioning) and lateral (arthroscopic Brostrom) 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 combined medial and lateral arthroscopic repair may be an effective and safe alternative in the treatment of multidirectional instability. 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.
Design: Level IV. Retrospective case series.
Keywords: ankle injuries; lateral ligament; collateral ligaments; joint instability
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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SP
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Sao Paulo, SP, Brazil, 04022-001
- Federal University of São Paulo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- complaints about ankle loosening for the last six months
- clinical findings of lateral and medial instability
Exclusion Criteria:
- existence of previous surgery
- autoimmune diseases
- neuropathy
- inflammatory disease
- isolated medial instability
- flatfoot
- previous ankle infiltration
- radiographic findings of ankle arthritis
- cavovarus deformity
- coagulopathies
- body mass index over 35
- associated injuries, such as osteochondral lesions
- syndesmosis instability
- tendon ruptures
- fractures
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Multidirectional
Arthroscopic lateral ligament repair combined with deltoid arthroscopic ligament repair.
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After anesthesia and surgical site preparation, traditional arthroscopic portals were performed.
A 4.5mm set was used to clean the joint and assess possible associated injuries.
Anterolateral and anteromedial impacts were resected when needed.
Lateral and medial instability were confirmed arthroscopically, and ligament repairs prepared, starting by the lateral compartment.
A traditional Arthroscopic Brostrom was performed, using one anchor and suture passers.
Sutures are passed but not tightened.
Medial anchor insertion is executed at the medial malleolus, in the quadrant described by Vega et al.
Sutures were passed respecting the safe zone illustrated by Acevedo at al.
The ankle was positioned in neutral (no posterior drawer) and the lateral sutures tightened with arthroscopic knots.
Finally, the medial repair is finalized by tightening the deltoid sutures with the ankle at the same position.
Portals were closed and a dressing applied.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
American Orthopedic Foot and Ankle Society - Hindfoot Score (AOFAS)
Time Frame: 6th post-operataive month
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Functional Score (0 to 100 | 100 best score possible | 0 worst score possible)
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6th post-operataive month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale (VAS)
Time Frame: 6th post-operataive month
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Pain Score (0 to 10 | 10 worst score possible | 0 best score possible)
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6th post-operataive month
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Complications
Time Frame: 6th post-operataive month
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Surgical complications
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6th post-operataive month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nacime Salomão Barbachan Mansur, MD, PhD, Federal University of São Paulo
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Multi_EPM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
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
Studies a U.S. FDA-regulated device product
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