Trials / Completed
CompletedNCT05062265
Internal Brace Augmented Anterior Inferior Tibiofibular Ligament Repair: Post-operative Syndesmotic Volumes.
Internal Brace Augmented Anterior Inferior Tibiofibular Ligament Repair and Its Post-operative Effects on Syndesmotic Volumes: A Prospective, Single-blinded, Randomized Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Vann Virginia Center for Orthopaedics dba Atlantic Orthopaedic Specialists · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Tight rope fixation | a traditional tight rope fixation is performed on one randomized set of subjects |
| DEVICE | Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace | A tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace set of subjects to compare syndesmotic volume |
Timeline
- Start date
- 2022-01-31
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
- First posted
- 2021-09-30
- Last updated
- 2025-02-19
- Results posted
- 2025-02-19
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05062265. Inclusion in this directory is not an endorsement.