NCT05062265

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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 30, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

January 31, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 19, 2025

Completed
Last Updated

February 19, 2025

Status Verified

January 1, 2025

Enrollment Period

1.9 years

First QC Date

July 27, 2021

Results QC Date

January 28, 2025

Last Update Submit

January 28, 2025

Conditions

Syndesmotic InjuriesLigament RuptureBimalleolar FracturesTrimalleolar Fractures

Outcome Measures

Primary Outcomes (2)

  • Syndesmotic Volumetric Ratio

    use of weight-bearing CT scan to measure; In order to compare the 3D syndesmotic volume between groups, the volume ratio was calculated for each patient by dividing the syndesmotic volume of the operative ankle by the syndesmotic volume of the contralateral uninjured ankle

    6-Weeks Post-op

  • Syndesmotic Volumetric Ratio

    use of weight-bearing CT scan to measure; In order to compare the 3D syndesmotic volume between groups, the volume ratio was calculated for each patient by dividing the syndesmotic volume of the operative ankle by the syndesmotic volume of the contralateral uninjured ankle

    3 months post-operative volume

Secondary Outcomes (8)

  • 36-Item Short Form Survey Instrument (RAND-36) Summary Scores

    6 weeks post-operative

  • RAND-36 Summary Scores

    3 months post-operative

  • RAND-36 Summary Scores

    6 months post-operative

  • RAND-36 Summary Scores

    1 year post-operative

  • Foot and Ankle Outcome Score (FAOS)

    6 weeks post-operative

  • +3 more secondary outcomes

Study Arms (2)

Tight Rope Fixation

ACTIVE COMPARATOR
Device: Tight rope fixation

tight rope fixation w/ AITFL repair augmentation with an internal brace

ACTIVE COMPARATOR
Device: Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace

Interventions

Tight rope fixationDEVICE

a traditional tight rope fixation is performed on one randomized set of subjects

Tight Rope Fixation
Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal braceDEVICE

A tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace set of subjects to compare syndesmotic volume

tight rope fixation w/ AITFL repair augmentation with an internal brace

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who fit the study injury list

You may not qualify if:

  • smokers
  • prior surgery on ankle
  • bi-lateral surgery
  • recent participation in another study within the last 90days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlantic Orthopaedic Specialists

Virginia Beach, Virginia, 23456, United States

Location

MeSH Terms

Conditions

Ankle InjuriesAnkle Fractures

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesFractures, Bone

Results Point of Contact

Title
Dr. Ashley Suttmiller
Organization
Atlantic Orthopaedic
suttmilera@atlanticortho.com
7573213300

Study Officials

  • Blake E Moore, MD

    Vann Virginia Center for Orthopaedics dba Atlantic Orthopaedic Specialists

    PRINCIPAL INVESTIGATOR

  • Ashley Suttmiller, PhD

    Clinical Researcher

    STUDY CHAIR

  • Brice A Snyder, MSAT

    Director of Clinical Research

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 27, 2021

First Posted

September 30, 2021

Study Start

January 31, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 19, 2025

Results First Posted

February 19, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)