NCT04933045

Brief Summary

The primary objective is to evaluate indications and outcomes of operative fixation of syndesmotic injuries, at least in part, with direct anatomic augmentation in acute and subacute traumatic cases. The secondary objective of the study is to evaluate clinically the InternalBraceTm to facilitate the direct syndesmotic fixation/augmentation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 21, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

June 21, 2021

Status Verified

June 1, 2021

Enrollment Period

6 months

First QC Date

June 13, 2021

Last Update Submit

June 13, 2021

Conditions

Syndesmotic Injuries

Keywords

Syndesmosis

Outcome Measures

Primary Outcomes (1)

  • Indications and outcomes of operative fixation of syndesmotic injuries

    Evaluate indicatinos and outcomes of operative fixation of syndesmotic injuries at least in part with direct anatomic augmentation in acute and subacute traumatic ankle fracture cases.

    1 year

Secondary Outcomes (1)

  • InternalBrace

    1 yeaer

Study Arms (1)

Syndesmotic Fixation Group

Cohort of patients treated with anatomic ATFL reconstruction for syndesmotic ankle injury.

Device: Arthrex InternalBrace

Interventions

Arthrex InternalBraceDEVICE

Placement of Arthrex InternalBrace for anatomic distal tibiofibular ligament augmentation to stabilize the ankle syndesmosis during surgery.

Syndesmotic Fixation Group

Eligibility Criteria

Age18 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Skeletally mature patients that occurred an ankle syndesmotic injury necessitating surgical stabilization/fixation

You may qualify if:

  • Skeletally mature patients that occurred an ankle syndesmotic injury necessitating surgical stabilization/fixation

You may not qualify if:

  • Skeletally immature patients, patients with nonoperatively managed ankle injuries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Clair Orthopedics and Sports Medicine

Saint Clair Shores, Michigan, 48080, United States

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Central Study Contacts

Christopher Zingas, MD

CONTACT

313-689-7030cmzingas@me.com

Matthew Schuch, DO

CONTACT

616-848-9119schuchm11@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic Surgeon

Study Record Dates

First Submitted

June 13, 2021

First Posted

June 21, 2021

Study Start

July 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

June 21, 2021

Record last verified: 2021-06

Locations

US(1)