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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ligament Rupture; Syndesmotic Injuries; Bimalleolar Fractures; Trimalleolar Fractures
• Intervention / Treatment: Device: Tight rope fixation; Device: Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Virginia Beach, Virginia, United States, 23456
      • Atlantic Orthopaedic Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Syndesmotic volume	use of weight-bearing CT scan to measure	preoperative volume
Syndesomotic Volume	use of weight-bearing CT scan to measure	6 weeks post-operative volume
Syndesomotic Volume	use of weight-bearing CT scan to measure	3 months post-operative volume

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	preoperative
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.	6 weeks post-operative
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.	3 months post-operative
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.	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. The result can be plotted as an outcome profile.	preoperative
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.	6weeks 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. The result can be plotted as an outcome profile.	3month 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. The result can be plotted as an outcome profile.	6month post-operative

Collaborators and Investigators

• Sponsor: Vann Virginia Center for Orthopaedics dba Atlantic Orthopaedic Specialists
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): January 31, 2022
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 30, 2021

Study Record Updates

• Last Update Posted (Actual): January 19, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Rupture; Fractures, Bone; Ankle Injuries; Ankle Fractures
• Other Study ID Numbers: AOS-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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