Syndesmotic InjuriesNCT05062265

Internal Brace Augmented Anterior Inferior Tibiofibular Ligament Repair: Post-operative Syndesmotic Volumes.

A study testing Tight rope fixation and Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace in people with Syndesmotic Injuries and Ligament Rupture, run by Vann Virginia Center for Orthopaedics dba Atlantic Orthopaedic Specialists at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Syndesmotic Injuries, Ligament Rupture, Bimalleolar Fractures
What is being tested?: Tight rope fixation and Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited States
Study dates: 31 Jan 2022to 31 Dec 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

patients who fit the study injury list

Who cannot join

smokers
prior surgery on ankle
bi-lateral surgery
recent participation in another study within the last 90days

Trial locations and contacts

1 site in 1 country.

United States1 site

Atlantic Orthopaedic Specialists
Virginia Beach, Virginia, 23456

Other trials in United States

About this study

Official title: Internal Brace Augmented Anterior Inferior Tibiofibular Ligament Repair and Its Post-operative Effects on Syndesmotic Volumes: A Prospective, Single-blinded, Randomized Study

Over the course of a year from the start of the research study, twenty subjects will be randomized evenly into one of two groups after an informed consent is obtained: a traditional tight rope fixation group or a tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace group. Postoperative reduction was assessed by 3D volumetric ratios and measured by weight-bearing CT at 6-weeks and 3-months post-operation. Patient Reported Outcomes (PROs) were collected preoperatively, and at 6-weeks, 3-months, 6-months, and 1-year post-operation and included the Foot and Ankle Outcome Score and the 36-Item Short Form Survey Instrument (RAND-36) . Differences in volumetric ratios and PROs were evaluated between groups and time periods.

Conditions: Syndesmotic Injuries, Ligament Rupture, Bimalleolar Fractures, Trimalleolar Fractures
Being tested: Tight rope fixation, Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace
Medical subject headings: Ankle Injuries, Ankle Fractures

What participants receive

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

Tight rope fixationDevice
a traditional tight rope fixation is performed on one randomized set of subjects
Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal braceDevice
A tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace set of subjects to compare syndesmotic volume

Study groups in NCT05062265
Study group	Role	What they receive
Tight Rope Fixation	Active comparator	Not described Receives: Device: Tight rope fixation
tight rope fixation w/ AITFL repair augmentation with an internal brace	Active comparator	Not described Receives: Device: Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace

What is being measured

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

Syndesmotic Volumetric Ratio
use of weight-bearing CT scan to measure; In order to compare the 3D syndesmotic volume between groups, the volume ratio was calculated for each patient by dividing the syndesmotic volume of the operative ankle by the syndesmotic volume of the contralateral uninjured ankle
Measured: 6-Weeks Post-op
Syndesmotic Volumetric Ratio
use of weight-bearing CT scan to measure; In order to compare the 3D syndesmotic volume between groups, the volume ratio was calculated for each patient by dividing the syndesmotic volume of the operative ankle by the syndesmotic volume of the contralateral uninjured ankle
Measured: 3 months post-operative volume

Secondary outcomes (8)

36-Item Short Form Survey Instrument (RAND-36) Summary Scores
The RAND-36 is a health-related quality-of-life questionnaire consisting of 36 questions that measure eight health domains to assess physical and mental health. Scores are 00-100. Higher scores equate to better quality of life and inverse for lower scores. The Physical Health Component and Mental Health Component summary scores were calculated using the oblique method to reduce the risk of underrepresenting mental health scores.
Measured: 6 weeks post-operative
RAND-36 Summary Scores
The Short Form-36 (SF-36 or RAND-36) is a health-related quality-of-life questionnaire consisting of 36 questions that measure eight health domains to assess physical and mental health. Scores are 00-100. Higher scores equate to better quality of life and inverse for lower scores. The Physical Health Component and Mental Health Component summary scores were calculated using the oblique method to reduce the risk of underrepresenting mental health scores.
Measured: 3 months post-operative
RAND-36 Summary Scores
The SF-36 is a health-related quality-of-life questionnaire consisting of 36 questions that measure eight health domains to assess physical and mental health. Scores are 00-100. Higher scores equate to better quality of life and inverse for lower scores. The Physical Health Component and Mental Health Component summary scores were calculated using the oblique method to reduce the risk of underrepresenting mental health scores.
Measured: 6 months post-operative
RAND-36 Summary Scores
The SF-36 is a health-related quality-of-life questionnaire consisting of 36 questions that measure eight health domains to assess physical and mental health. Scores are 00-100. Higher scores equate to better quality of life and inverse for lower scores. The Physical Health Component and Mental Health Component summary scores were calculated using the oblique method to reduce the risk of underrepresenting mental health scores.
Measured: 1 year post-operative
Foot and Ankle Outcome Score (FAOS)
FAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport(Rec), and foot and ankle-related Quality of Life (QOL). The last week is taken into consideration when answering the questionnaire. Standardized answer options are given (% Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: 6 weeks post-operative
Foot and Ankle Outcome Score (FAOS)
FAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport(Rec), and foot and ankle-related Quality of Life (QOL). The last week is taken into consideration when answering the questionnaire. Standardized answer options are given (% Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: 3 months post-operative
Foot and Ankle Outcome Score (FAOS)
FAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport(Rec), and foot and ankle-related Quality of Life (QOL). The last week is taken into consideration when answering the questionnaire. Standardized answer options are given (% Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: 6 months post-operative
Foot and Ankle Outcome Score (FAOS)
FAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport(Rec), and foot and ankle-related Quality of Life (QOL). The last week is taken into consideration when answering the questionnaire. Standardized answer options are given (% Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: 1 year post-operative

Timeline

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

31 Jan 202231 Dec 2023

First posted30 Sep 2021
Study start31 Jan 2022
Primary completion31 Dec 2023
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05062265
Sponsor's protocol ID: AOS-0001
Status last verified: Jan 2025
First submitted: 27 Jul 2021
Last updated: 19 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Dynamic Fixation for Complex Ankle Fractures With Syndesmotic Diastasis.
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Active, not recruiting
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All Syndesmotic Injuries trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Internal Brace Augmented Anterior Inferior Tibiofibular Ligament Repair and Its Post-operative Effects on Syndesmotic Volumes: A Prospective, Single-blinded, Randomized Study
ClinicalTrials.gov ID: NCT05062265
Acronym / sponsor ID: AOS-0001
Conditions: Syndesmotic Injuries, Ligament Rupture, Bimalleolar Fractures, Trimalleolar Fractures
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Vann Virginia Center for Orthopaedics dba Atlantic Orthopaedic SpecialistsUniversity, hospital or other
Collaborators: Arthrex, Inc.
Study start: 31 Jan 2022 (actual)
Primary completion: 31 Dec 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 30 Sep 2021 (actual)
Results: Posted 19 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Tight Rope Fixation	Active comparator	Device: Tight rope fixation
tight rope fixation w/ AITFL repair augmentation with an internal brace	Active comparator	Device: Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

patients who fit the study injury list

Key exclusion criteria (4 listed)

smokers
prior surgery on ankle
bi-lateral surgery
recent participation in another study within the last 90days

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
Tight rope fixationa traditional tight rope fixation is performed on one randomized set of subjects	Device	Tight Rope Fixation
Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal braceA tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace set of subjects to compare syndesmotic volume	Device	tight rope fixation w/ AITFL repair augmentation with an internal brace

Primary outcome

Syndesmotic Volumetric Ratio
Time frame: 6-Weeks Post-op
use of weight-bearing CT scan to measure; In order to compare the 3D syndesmotic volume between groups, the volume ratio was calculated for each patient by dividing the syndesmotic volume of the operative ankle by the syndesmotic volume of the contralateral uninjured ankle
Syndesmotic Volumetric Ratio
Time frame: 3 months post-operative volume
use of weight-bearing CT scan to measure; In order to compare the 3D syndesmotic volume between groups, the volume ratio was calculated for each patient by dividing the syndesmotic volume of the operative ankle by the syndesmotic volume of the contralateral uninjured ankle

8 secondary outcomes

36-Item Short Form Survey Instrument (RAND-36) Summary Scores
Time frame: 6 weeks post-operative
RAND-36 Summary Scores
Time frame: 3 months post-operative
RAND-36 Summary Scores
Time frame: 6 months post-operative
RAND-36 Summary Scores
Time frame: 1 year post-operative
Foot and Ankle Outcome Score (FAOS)
Time frame: 6 weeks post-operative
Foot and Ankle Outcome Score (FAOS)
Time frame: 3 months post-operative
Foot and Ankle Outcome Score (FAOS)
Time frame: 6 months post-operative
Foot and Ankle Outcome Score (FAOS)
Time frame: 1 year post-operative

Results and safety

Results posted to the registry on 19 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tight Rope Fixation	12	11
Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace	9	9

Primary outcome: Syndesmotic Volumetric Ratio

Time frame: 6-Weeks Post-op. Mean (Standard Deviation). Unit: Volumetric Ratio

Measure	Tight Rope Fixation n = 11	Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace n = 9
Value	1.2 (0.2)	1.1 (0.1)

Primary outcome: Syndesmotic Volumetric Ratio

Time frame: 3 months post-operative volume. Mean (Standard Deviation). Unit: Volumetric Ratio

Measure	Tight Rope Fixation n = 11	Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace n = 9
Value	1.2 (0.3)	1.1 (0.3)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year follow up from surgery date.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tight Rope Fixation	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace	1 of 9 (11.1%)	0 of 9 (0%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Syndesmotic Injuries

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Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
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RecruitingObservational study
Use of Bioresorbable Magnesium Set Screws in Syndesmotic Injuries: a Pilot Study
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Computed Tomography With Stress Maneuvers for Evaluation of Distal Tibiofibular Syndesmosis Instability (CTMETS)
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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.

Blake E Moore, MD principal investigator

Vann Virginia Center for Orthopaedics dba Atlantic Orthopaedic Specialists

Ashley Suttmiller, PhD study chair

Clinical Researcher

Brice A Snyder, MSAT study director

Director of Clinical Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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 Feb 2025. 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?

Yes. Results are posted in the registry (first posted 19 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Syndesmotic Volumetric Ratio (time frame: 6-Weeks Post-op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05062265.

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 Feb 2025.