Internal Brace Augmented Anterior Inferior Tibiofibular Ligament Repair: Post-operative Syndesmotic Volumes.

Syndesmotic Injuries Clinical Trial

Official title:

Internal Brace Augmented Anterior Inferior Tibiofibular Ligament Repair and Its Post-operative Effects on Syndesmotic Volumes: A Prospective, Single-blinded, Randomized Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05062265
• Other study ID #: AOS-0001
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Vann Virginia Center for Orthopaedics dba Atlantic Orthopaedic Specialists
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fractures
• Ankle Injuries
• Fractures, Bone
• Ligament Rupture
• Rupture
• Syndesmotic Injuries

Intervention

Device:
• Tight rope fixation
a traditional tight rope fixation is performed on one randomized set of subjects
• 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

Locations

Country	Name	City	State
United States	Atlantic Orthopaedic Specialists	Virginia Beach	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Vann Virginia Center for Orthopaedics dba Atlantic Orthopaedic Specialists	Arthrex, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Syndesmotic volume	use of weight-bearing CT scan to measure	preoperative volume
Primary	Syndesomotic Volume	use of weight-bearing CT scan to measure	6 weeks post-operative volume
Primary	Syndesomotic Volume	use of weight-bearing CT scan to measure	3 months post-operative volume
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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