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Syndesmotic InjuriesNCT04933045

Treatment of Syndesmotic Disruption With Anatomic Distal Tibiofibular Ligament Augmentation

An observational study of Syndesmotic Injuries, run by St. Clair Orthopaedics at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary objective is to evaluate indications and outcomes of operative fixation of syndesmotic injuries, at least in part, with direct anatomic augmentation in acute and subacute traumatic cases. Read more about this study

Who is it for?
Ages 18 to 105 years
Conditions the study is for
Syndesmotic Injuries
What is being tested?
Arthrex InternalBrace
Type of treatment
Medical device
How many people
32 participants
Where
1 siteUnited States
Study dates
1 Jul 2021to 31 Dec 2021
How long will I take part?
1 Year
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 18 to 105 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Skeletally mature patients that occurred an ankle syndesmotic injury necessitating surgical stabilization/fixation

Who may be able to join

  • Skeletally mature patients that occurred an ankle syndesmotic injury necessitating surgical stabilization/fixation

Who cannot join

  • Skeletally immature patients, patients with nonoperatively managed ankle injuries

Trial locations and contacts

1 site in 1 country.

Christopher Zingas, MD contact

313-689-7030

cmzingas@me.com

Matthew Schuch, DO contact

616-848-9119

schuchm11@gmail.com

United States1 site
  • St Clair Orthopedics and Sports Medicine

    Saint Clair Shores, Michigan, 48080

Other trials in United States

About this study

The primary objective is to evaluate indications and outcomes of operative fixation of syndesmotic injuries, at least in part, with direct anatomic augmentation in acute and subacute traumatic cases. The secondary objective of the study is to evaluate clinically the InternalBraceTm to facilitate the direct syndesmotic fixation/augmentation.

Read the detailed description

A syndesmosis is a slightly movable fibrous joint in which bones such as the tibia and fibula are joined together by connnective tissue. Together, they form a bracket shaped socket, covered in hyaline cartilage. This socket is known as the mortise. A syndesmotic or 'high 'ankle sprain is when the ligaments binding the distal tibia and fibula at the ankle joint are injured or torn. This can lead to the ankle joint and syndesmoses to being malaligned, subluxed or widened. Subsequently, this can lead to ankle arthritis and deformity with persistent pain and swelling about the ankle.

There are no generally accepted treatment guidelines. Thus, there still remains considerable controversies regarding diagnosis, classification and treatment of syndesmotic injuries. Syndesmotic malreduction is the most common indication for early re-operation after ankle fracture surgery, and widening of the ankle mortise by only 1 mm decreases the contact area of the tibiotalar joint by 42%. Outcome of ankle fractures with syndesmosis injury is worse than without, even after surgical syndesmotic stabilization. This may be due to a high incidence of syndesmotic malreduction revealed by increasing postoperative computed tomography controls. Therefore, even open visualization of the syndesmosis during the reduction maneuver has been recommended. Thus, the most important clinical predictor of outcome is consistently reported as accuracy of anatomic reduction of the injured syndesmosis. In 2017 a new syndesmotic InternalBraceTM technique for improved anatomic distal tibiofibular ligament augmentation to protect healing of the injured native ligaments was introduced. This technique involves direct surgical inspection of the syndesmoses for injury and subsequent augmentation.

This study hopes to evaluate the results of this direct syndesmotic augmentation/stabilization to help determine if this is perhaps a safer, and possibly more effective method.

This prospective study is designed to evaluate 32 consecutive patients that did have an acute or subacute syndesmotic injury that necessitated surgical stabilization and used at least in part the InternalBrace technique. There was not a restriction of age, gender, or race.

2 patients who were labeled as having severe syndesmotic disruption and had additional screw fixation. Also, 5 patients had dynamic syndesmotic fixation in addition to direct InternalBrace augmentation of the AITFL.

The patents will or had had plain radiographs and physical examination of injured ankle 1 week, 1 month, 3 months, 6 months and 12 months. Also, at minimum 12 months post operatively a physical exam and plain radiograph contralateral uninjured ankle to be performed as comparison/control. At minimum 12 months post operative additional patent report outcomes such as AOFAS/VAS scores and return to pre-injury status recreationally/work level to be evaluated. The ankle anatomic syndesomotic and mortise alignment has been associated with long term outcomes.

Being tested
Arthrex InternalBrace
Keywords
Syndesmosis
Medical subject headings
Ankle Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arthrex InternalBraceDevice

    Placement of Arthrex InternalBrace for anatomic distal tibiofibular ligament augmentation to stabilize the ankle syndesmosis during surgery.

Study groups in NCT04933045
Study groupRoleWhat they receive
Syndesmotic Fixation GroupCohort of patients treated with anatomic ATFL reconstruction for syndesmotic ankle injury.
Receives: Device: Arthrex InternalBrace

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Indications and outcomes of operative fixation of syndesmotic injuries

    Evaluate indicatinos and outcomes of operative fixation of syndesmotic injuries at least in part with direct anatomic augmentation in acute and subacute traumatic ankle fracture cases.

    Measured: 1 year

Secondary outcomes (1)
  1. InternalBrace

    Evaluate clinically the InternalBrace to facilitate the direct syndesmotic fixation/augmentation.

    Measured: 1 yeaer

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2021
  2. Study start1 Jul 2021 (estimated)
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
32 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT04933045
Sponsor's protocol ID
Syndesmotic Augmentation
Status last verified
Jun 2021
First submitted
13 Jun 2021
Last updated
21 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Syndesmotic Injuries, run by St. Clair Orthopaedics at 1 site in United States.

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 1 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: status not confirmed, as of the sponsor's last update on 21 Jun 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 United States. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Christopher Zingas, MD (313-689-7030, cmzingas@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Indications and outcomes of operative fixation of syndesmotic injuries (time frame: 1 year). 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 21 Jun 2021.

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