N/A
N=21
Internal Brace Augmented Anterior Inferior Tibiofibular Ligament Repair: Post-operative Syndesmotic Volumes.
Syndesmotic Injuries · Ligament Rupture · Bimalleolar Fractures · Trimalleolar Fractures
Bottom Line
View on ClinicalTrials.gov: NCT05062265 ↗Enrolled (actual)
21
Serious AEs
4.8%
Results posted
Feb 2025
Primary outcome: Primary: Syndesmotic Volumetric Ratio — 1.2; 1.1 Volumetric Ratio
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tight rope fixation (Device); Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vann Virginia Center for Orthopaedics dba Atlantic Orthopaedic Specialists
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Syndesmotic Volumetric Ratio |
1.2; 1.1 | — |
| PRIMARY Syndesmotic Volumetric Ratio |
1.2; 1.1 | — |
| SECONDARY 36-Item Short Form Survey Instrument (RAND-36) Summary Scores |
35.2; 36.3; 45.3; 47.6 | — |
| SECONDARY RAND-36 Summary Scores |
49.7; 51; 53.3; 54.9 | — |
| SECONDARY RAND-36 Summary Scores |
49.7; 51; 53.3; 54.9 | — |
| SECONDARY RAND-36 Summary Scores |
49.7; 51; 53.3; 54.9 | — |
| SECONDARY Foot and Ankle Outcome Score (FAOS) |
80.5; 87; 73.6; 80.3; 87.1; 90.8 | — |
| SECONDARY Foot and Ankle Outcome Score (FAOS) |
80.5; 87; 73.6; 80.3; 87.1; 90.8 | — |
| SECONDARY Foot and Ankle Outcome Score (FAOS) |
80.5; 87; 73.6; 80.3; 87.1; 90.8 | — |
| SECONDARY Foot and Ankle Outcome Score (FAOS) |
80.5; 87; 73.6; 80.3; 87.1; 90.8 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- patients who fit the study injury list
Exclusion Criteria
- smokers
- prior surgery on ankle
- bi-lateral surgery
- recent participation in another study within the last 90days
Data sourced from ClinicalTrials.gov (NCT05062265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.