Treatment of Syndesmotic Disruption With Anatomic Distal Tibiofibular Ligament Augmentation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Syndesmotic Injuries
• Intervention / Treatment: Device: Arthrex InternalBrace

Detailed Description

A syndesmosis is a slightly movable fibrous joint in which bones such as the tibia and fibula are joined together by connnective tissue. Together, they form a bracket shaped socket, covered in hyaline cartilage. This socket is known as the mortise. A syndesmotic or 'high 'ankle sprain is when the ligaments binding the distal tibia and fibula at the ankle joint are injured or torn. This can lead to the ankle joint and syndesmoses to being malaligned, subluxed or widened. Subsequently, this can lead to ankle arthritis and deformity with persistent pain and swelling about the ankle.

There are no generally accepted treatment guidelines. Thus, there still remains considerable controversies regarding diagnosis, classification and treatment of syndesmotic injuries. Syndesmotic malreduction is the most common indication for early re-operation after ankle fracture surgery, and widening of the ankle mortise by only 1 mm decreases the contact area of the tibiotalar joint by 42%. Outcome of ankle fractures with syndesmosis injury is worse than without, even after surgical syndesmotic stabilization. This may be due to a high incidence of syndesmotic malreduction revealed by increasing postoperative computed tomography controls. Therefore, even open visualization of the syndesmosis during the reduction maneuver has been recommended. Thus, the most important clinical predictor of outcome is consistently reported as accuracy of anatomic reduction of the injured syndesmosis. In 2017 a new syndesmotic InternalBraceTM technique for improved anatomic distal tibiofibular ligament augmentation to protect healing of the injured native ligaments was introduced. This technique involves direct surgical inspection of the syndesmoses for injury and subsequent augmentation.

This study hopes to evaluate the results of this direct syndesmotic augmentation/stabilization to help determine if this is perhaps a safer, and possibly more effective method.

This prospective study is designed to evaluate 32 consecutive patients that did have an acute or subacute syndesmotic injury that necessitated surgical stabilization and used at least in part the InternalBrace technique. There was not a restriction of age, gender, or race.

2 patients who were labeled as having severe syndesmotic disruption and had additional screw fixation. Also, 5 patients had dynamic syndesmotic fixation in addition to direct InternalBrace augmentation of the AITFL.

The patents will or had had plain radiographs and physical examination of injured ankle 1 week, 1 month, 3 months, 6 months and 12 months. Also, at minimum 12 months post operatively a physical exam and plain radiograph contralateral uninjured ankle to be performed as comparison/control. At minimum 12 months post operative additional patent report outcomes such as AOFAS/VAS scores and return to pre-injury status recreationally/work level to be evaluated. The ankle anatomic syndesomotic and mortise alignment has been associated with long term outcomes.

• Study Type: Observational
• Enrollment (Anticipated): 32

Contacts and Locations

• Study Contact: Name: Christopher Zingas, MD; Phone Number: 313-689-7030; Email: cmzingas@me.com
• Study Contact Backup: Name: Matthew Schuch, DO; Phone Number: 616-848-9119; Email: schuchm11@gmail.com

Study Locations

• United States
  • Michigan
    • Saint Clair Shores, Michigan, United States, 48080
      • St Clair Orthopedics and Sports Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 105 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Skeletally immature patients, patients with nonoperatively managed ankle injuries

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Syndesmotic Fixation Group; Cohort of patients treated with anatomic ATFL reconstruction for syndesmotic ankle injury.	Device: Arthrex InternalBrace; Placement of Arthrex InternalBrace for anatomic distal tibiofibular ligament augmentation to stabilize the ankle syndesmosis during surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
InternalBrace	Evaluate clinically the InternalBrace to facilitate the direct syndesmotic fixation/augmentation.	1 yeaer

Collaborators and Investigators

• Sponsor: St. Clair Orthopaedics

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: June 13, 2021
• First Submitted That Met QC Criteria: June 13, 2021
• First Posted (ACTUAL): June 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 21, 2021
• Last Update Submitted That Met QC Criteria: June 13, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Syndesmosis
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries
• Other Study ID Numbers: Syndesmotic Augmentation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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.: No