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.
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.
United States1 site
St Clair Orthopedics and Sports Medicine
Saint Clair Shores, Michigan, 48080
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.
- Conditions
- Syndesmotic Injuries
- 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 group | Role | What they receive |
|---|---|---|
| Syndesmotic Fixation Group | Cohort 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.
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)
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.
- First posted21 Jun 2021
- Study start1 Jul 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Syndesmotic 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- St. Clair Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher N Zingas, St. Clair Orthopaedics
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Syndesmotic Disruption With Anatomic Distal Tibiofibular Ligament Augmentation
- ClinicalTrials.gov ID
- NCT04933045
- Acronym / sponsor ID
- Syndesmotic Augmentation
- Conditions
- Syndesmotic Injuries
- Keywords
- Syndesmosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- St. Clair OrthopaedicsUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 21 Jun 2021 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Syndesmotic Fixation Group | – | Device: Arthrex InternalBraceCohort of patients treated with anatomic ATFL reconstruction for syndesmotic ankle injury. |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Skeletally mature patients that occurred an ankle syndesmotic injury necessitating surgical stabilization/fixation
Key inclusion criteria (1 listed)
- Skeletally mature patients that occurred an ankle syndesmotic injury necessitating surgical stabilization/fixation
Key exclusion criteria (1 listed)
- Skeletally immature patients, patients with nonoperatively managed ankle injuries
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 |
|---|---|---|
| Arthrex InternalBracePlacement of Arthrex InternalBrace for anatomic distal tibiofibular ligament augmentation to stabilize the ankle syndesmosis during surgery. | Device | Syndesmotic Fixation Group |
Primary outcome
Indications and outcomes of operative fixation of syndesmotic injuries
Time frame: 1 year
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.
1 secondary outcome
InternalBrace
Time frame: 1 yeaer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Syndesmotic Injuries
Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
RecruitingObservational study
Use of Bioresorbable Magnesium Set Screws in Syndesmotic Injuries: a Pilot Study
Syndesmotic Injury, Trimalleolar Fracture
RecruitingObservational study
Computed Tomography With Stress Maneuvers for Evaluation of Distal Tibiofibular Syndesmosis Instability (CTMETS)
Ankle Sprain
Not yet recruiting
Dynamic Fixation for Complex Ankle Fractures With Syndesmotic Diastasis.
Ankle Fractures, Syndesmotic Injury of the Ankle
Active, not recruiting
Stability of Distal Tibiofibular Syndesmosis With or Without Fixation of Posterior Fragments in Bimalleolar Fractures
Ankle Fractures, Osteoarthritis, Ankle
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.
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 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.