Ankle InjuriesNCT04473638
Deltoid Ligament Arthroscopic Repair in Ankle Fractures: Case Series
An observational study of Ankle Injuries and Ankle Fractures, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
To demonstrate the functional results of patients with ankle fractures operated with arthroscopic deltoid repair. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Ankle Injuries, Ankle Fractures, Deltoid Ligament; Sprain (Strain) (Ankle)
- What is being tested?
- Arthroscopic Deltoid Repair
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2019to 10 Jul 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 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Tertiary/Quaternary hospital patients
Who may be able to join
- 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
Who cannot join
- previous surgery
- autoimmune diseases
- neuropathy
- inflammatory diseases
- radiographic preoperative findings of ankle arthritis
- open medial wound
- coagulopathies
- any other condition that would contraindicate surgery
Trial locations and contacts
1 site in 1 country.
About this study
To demonstrate the functional results of patients with ankle fractures operated with arthroscopic deltoid repair.
Read the detailed 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.
- Conditions
- Ankle Injuries, Ankle Fractures, Deltoid Ligament; Sprain (Strain) (Ankle), Ligament Rupture
- Being tested
- Arthroscopic Deltoid Repair
- Medical subject headings
- Ankle Injuries, Ankle Fractures, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic Deltoid RepairProcedure or surgery
. 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.
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic | Deltoid Arthroscopic Repair in Ankle Fractures Receives: Procedure: 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: Time Frame: 6th post-operative month
Secondary outcomes (2)
Visual Analogue Scale (VAS)
Pain Score (0 to 10 | 10 worst score possible | 0 best score possible)
Measured: Time Frame: 6th post-operative month
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.
Measured: 6th post-operative month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start1 Aug 2019
- Primary completion1 Nov 2020
- Study completion10 Jul 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
- 20 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
- NCT04473638
- Sponsor's protocol ID
- Arthroscopic_Deltoid_Fx_EPM
- Status last verified
- Jul 2021
- First submitted
- 13 Jul 2020
- Last updated
- 19 Jul 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 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deltoid Ligament Arthroscopic Repair in Ankle Fractures: Case Series
- ClinicalTrials.gov ID
- NCT04473638
- Acronym / sponsor ID
- Arthroscopic_Deltoid_Fx_EPM
- Conditions
- Ankle Injuries, Ankle Fractures, Deltoid Ligament; Sprain (Strain) (Ankle), Ligament Rupture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 10 Jul 2021 (actual)
- First posted
- 16 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.
To demonstrate the functional results of patients with ankle fractures operated with arthroscopic deltoid repair.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic | – | Procedure: Arthroscopic Deltoid RepairDeltoid Arthroscopic Repair in Ankle Fractures |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Tertiary/Quaternary hospital patients
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- previous surgery
- autoimmune diseases
- neuropathy
- inflammatory diseases
- radiographic preoperative findings of ankle arthritis
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 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. | Procedure or surgery | Arthroscopic |
Primary outcome
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)
2 secondary outcomes
Visual Analogue Scale (VAS)
Time frame: Time Frame: 6th post-operative month
Number of Complications related to Treatment
Time frame: 6th post-operative 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 19 Jul 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 Ankle Fractures, 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 1 inclusion and 8 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 19 Jul 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: Time Frame: 6th post-operative 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 19 Jul 2021.