Ankle InjuriesNCT04459910
Medial and Lateral Combined Ligament Arthroscopic Repair for Multidirectional Ankle Instability: Case Series
An observational study of Ankle Injuries and Ligament Injury, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Ankle Injuries, Ligament Injury, Joint Instability
- What is being tested?
- Arthroscopic Brostrom combined with Arthroscopic Deltoid Repair
- Type of treatment
- Surgery or procedure
- How many people
- 29 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2019to 1 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Tertiary teaching hospital patients, athletes and non-athletes.
Who may be able to join
- complaints about ankle loosening for the last six months
- clinical findings of lateral and medial instability
Who cannot join
- existence of previous surgery
- autoimmune diseases
- neuropathy
- inflammatory disease
- isolated medial instability
- flatfoot
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Conditions
- Ankle Injuries, Ligament Injury, Joint Instability, Deltoid Ligament; Sprain (Strain) (Ankle), Talofibular Ligament Tear
- Being tested
- Arthroscopic Brostrom combined with Arthroscopic Deltoid Repair
- Medical subject headings
- Ankle Injuries, Joint Instability, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic Brostrom combined with Arthroscopic Deltoid RepairProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Multidirectional | Arthroscopic lateral ligament repair combined with deltoid arthroscopic ligament repair. Receives: Procedure: Arthroscopic Brostrom combined with Arthroscopic Deltoid Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Orthopedic Foot and Ankle Society - Hindfoot Score (AOFAS)
Functional Score (0 to 100 | 100 best score possible | 0 worst score possible)
Measured: 6th post-operataive month
Secondary outcomes (2)
Visual Analogue Scale (VAS)
Pain Score (0 to 10 | 10 worst score possible | 0 best score possible)
Measured: 6th post-operataive month
Complications
Surgical complications
Measured: 6th post-operataive month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Jul 2019
- Primary completion1 Sep 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nacime Salomão Barbachan Mansur, Federal University of São Paulo
- Investigators
- Nacime Salomão Barbachan Mansur, MD, PhD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459910
- Sponsor's protocol ID
- Multi_EPM
- Status last verified
- Feb 2021
- First submitted
- 2 Jul 2020
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the ICMJE data sharing police, core records will be shared at an online depository and available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medial and Lateral Combined Ligament Arthroscopic Repair for Multidirectional Ankle Instability: Case Series
- ClinicalTrials.gov ID
- NCT04459910
- Acronym / sponsor ID
- Multi_EPM
- Conditions
- Ankle Injuries, Ligament Injury, Joint Instability, Deltoid Ligament; Sprain (Strain) (Ankle), Talofibular Ligament Tear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multidirectional | – | Procedure: Arthroscopic Brostrom combined with Arthroscopic Deltoid RepairArthroscopic lateral ligament repair combined with deltoid arthroscopic ligament repair. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Tertiary teaching hospital patients, athletes and non-athletes.
Key inclusion criteria (2 listed)
- complaints about ankle loosening for the last six months
- clinical findings of lateral and medial instability
Key exclusion criteria (15 listed)
- existence of previous surgery
- autoimmune diseases
- neuropathy
- inflammatory disease
- isolated medial instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic Brostrom combined with Arthroscopic Deltoid RepairAfter 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. | Procedure or surgery | Multidirectional |
Primary outcome
American Orthopedic Foot and Ankle Society - Hindfoot Score (AOFAS)
Time frame: 6th post-operataive month
Functional Score (0 to 100 | 100 best score possible | 0 worst score possible)
2 secondary outcomes
Visual Analogue Scale (VAS)
Time frame: 6th post-operataive month
Complications
Time frame: 6th post-operataive month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Individual participant dataSharing planned: Yes. According to the ICMJE data sharing police, core records will be shared at an online depository and available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nacime Salomão Barbachan Mansur, MD, PhD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Injuries and Ligament Injury, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Orthopedic Foot and Ankle Society - Hindfoot Score (AOFAS) (time frame: 6th post-operataive month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.