Internal Brace Augmented Anterior Inferior Tibiofibular Ligament Repair: Post-operative Syndesmotic Volumes.
Primary Purpose
Syndesmotic Injuries, Ligament Rupture, Bimalleolar Fractures
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tight rope fixation
Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace
Sponsored by
About this trial
This is an interventional diagnostic trial for Syndesmotic Injuries
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
Sites / Locations
- Atlantic Orthopaedic Specialists
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Tight Rope Fixation
tight rope fixation w/ AITFL repair augmentation with an internal brace
Arm Description
Outcomes
Primary Outcome Measures
Syndesmotic volume
use of weight-bearing CT scan to measure
Syndesomotic Volume
use of weight-bearing CT scan to measure
Syndesomotic Volume
use of weight-bearing CT scan to measure
Secondary Outcome Measures
36-Item Short Form Survey
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
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
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
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)
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)
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)
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)
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.
Full Information
NCT ID
NCT05062265
First Posted
July 27, 2021
Last Updated
January 17, 2023
Sponsor
Vann Virginia Center for Orthopaedics dba Atlantic Orthopaedic Specialists
Collaborators
Arthrex, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05062265
Brief Title
Internal Brace Augmented Anterior Inferior Tibiofibular Ligament Repair: Post-operative Syndesmotic Volumes.
Official Title
Internal Brace Augmented Anterior Inferior Tibiofibular Ligament Repair and Its Post-operative Effects on Syndesmotic Volumes: A Prospective, Single-blinded, Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vann Virginia Center for Orthopaedics dba Atlantic Orthopaedic Specialists
Collaborators
Arthrex, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syndesmotic Injuries, Ligament Rupture, Bimalleolar Fractures, Trimalleolar Fractures
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tight Rope Fixation
Arm Type
Active Comparator
Arm Title
tight rope fixation w/ AITFL repair augmentation with an internal brace
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Tight rope fixation
Intervention Description
a traditional tight rope fixation is performed on one randomized set of subjects
Intervention Type
Device
Intervention Name(s)
Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace
Intervention Description
A tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace set of subjects to compare syndesmotic volume
Primary Outcome Measure Information:
Title
Syndesmotic volume
Description
use of weight-bearing CT scan to measure
Time Frame
preoperative volume
Title
Syndesomotic Volume
Description
use of weight-bearing CT scan to measure
Time Frame
6 weeks post-operative volume
Title
Syndesomotic Volume
Description
use of weight-bearing CT scan to measure
Time Frame
3 months post-operative volume
Secondary Outcome Measure Information:
Title
36-Item Short Form Survey
Description
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.
Time Frame
preoperative
Title
36-Item Short Form Survey
Description
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.
Time Frame
6 weeks post-operative
Title
36-Item Short Form Survey
Description
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.
Time Frame
3 months post-operative
Title
36-Item Short Form Survey
Description
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.
Time Frame
6 months post-operative
Title
Foot and Ankle Outcome Score (FAOS)
Description
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.
Time Frame
preoperative
Title
Foot and Ankle Outcome Score (FAOS)
Description
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.
Time Frame
6weeks post-operative
Title
Foot and Ankle Outcome Score (FAOS)
Description
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.
Time Frame
3month post-operative
Title
Foot and Ankle Outcome Score (FAOS)
Description
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.
Time Frame
6month post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Blake E Moore, MD
Organizational Affiliation
Vann Virginia Center for Orthopaedics dba Atlantic Orthopaedic Specialists
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ashley Suttmiller, PhD
Organizational Affiliation
Clinical Researcher
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Brice A Snyder, MSAT
Organizational Affiliation
Director of Clinical Research
Official's Role
Study Director
Facility Information:
Facility Name
Atlantic Orthopaedic Specialists
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Internal Brace Augmented Anterior Inferior Tibiofibular Ligament Repair: Post-operative Syndesmotic Volumes.
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