Internal Brace Augmented Anterior Inferior Tibiofibular Ligament Repair: Post-operative Syndesmotic Volumes.
Study Details
Study Description
Brief 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. Subjects in both groups will acquire a bilateral WBCT pre-operatively and 6 weeks post-operatively at Atlantic Orthopaedic Specialists office. A within group statistical analyses will compare the volume of the syndesmosis acquired by the WBCT at 6 weeks.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Tight Rope Fixation
|
Device: Tight rope fixation
a traditional tight rope fixation is performed on one randomized set of subjects
|
| Active Comparator: tight rope fixation w/ AITFL repair augmentation with an internal brace
|
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
|
Outcome Measures
Primary Outcome Measures
- Syndesmotic volume [preoperative volume]
use of weight-bearing CT scan to measure
- Syndesomotic Volume [6 weeks post-operative volume]
use of weight-bearing CT scan to measure
- Syndesomotic Volume [3 months post-operative volume]
use of weight-bearing CT scan to measure
Secondary Outcome Measures
- 36-Item Short Form Survey [preoperative]
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.
- 36-Item Short Form Survey [6 weeks post-operative]
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.
- 36-Item Short Form Survey [3 months post-operative]
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.
- 36-Item Short Form Survey [6 months post-operative]
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.
- Foot and Ankle Outcome Score (FAOS) [preoperative]
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. The result can be plotted as an outcome profile.
- Foot and Ankle Outcome Score (FAOS) [6weeks post-operative]
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. The result can be plotted as an outcome profile.
- Foot and Ankle Outcome Score (FAOS) [3month post-operative]
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. The result can be plotted as an outcome profile.
- Foot and Ankle Outcome Score (FAOS) [6month post-operative]
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. The result can be plotted as an outcome profile.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Atlantic Orthopaedic Specialists | Virginia Beach | Virginia | United States | 23456 |
Sponsors and Collaborators
- Vann Virginia Center for Orthopaedics dba Atlantic Orthopaedic Specialists
- Arthrex, Inc.
Investigators
- Principal Investigator: Blake E Moore, MD, Vann Virginia Center for Orthopaedics dba Atlantic Orthopaedic Specialists
- Study Chair: Ashley Suttmiller, PhD, Clinical Researcher
- Study Director: Brice A Snyder, MSAT, Director of Clinical Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AOS-0001