Investigation of Corticosteroid Versus Placebo Injection in Patients With Syndesmotic Ligament Injury or High Ankle Sprain

January 18, 2024 updated by: Sanford Health

Single-site, Double Blinded, Randomized Investigation of Corticosteroid Versus Placebo Injection Under Ultrasound Guidance in Patients With Syndesmotic Ligament Injury or High Ankle Sprain

This study evaluates the use of corticosteroids acutely as an adjuvant treatment of the high ankle sprain. Subjects will receive either a corticosteroid or a local anesthetic injection.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The term "high ankle sprain" refers to injury to the syndesmotic ligaments of the ankle. It has become a much more common injury comprising up to 24.6% of all ankle sprains , with an incidence of 2.4 per 1000 athlete exposures. These can present a significant therapeutic challenge for the sports physician and typically result in a prolonged morbidity and delayed return to activity. The literature shows a lack of information for definitive care of these athletes. Typical recovery for the high ankle sprain is almost twice as long as the more common lateral ankle inversion sprain with a mean time to return to play of 45 days. There is also a higher incidence of residual chronic pain comparing high ankle sprains to an isolated lateral ankle sprain. The current standard for treatment of this injury has been to depend on symptomatic treatment with an initial phase of rest and protected splinting. This is followed by the use of NSAID's with a graduated rehabilitation program to reduce swelling, improve range of motion, and regain strength and proprioception of the ankle. This is followed by protective taping or bracing and return to activities as tolerated. Inflammation is one of the body's first reactions to injury. Release of damaged cells and tissue debris occurs upon injury. These expelled particles act as antigens to stimulate a nonspecific immune response and to cause the proliferation of leukocytes. Local blood flow increases to transport the polymorphonuclear leukocytes, macrophages, and plasma proteins to the injured area. A redistribution of arteriolar flow produces stasis and hypoxia at the injury site. The resulting infiltration of tissues by the leukocytes, plasma proteins, and fluid causes the redness, swelling, and pain that are characteristic of inflammation. Initially, the inflammatory reaction serves several important purposes. The influx of leukocytes facilitates the process of phagocytosis and the removal of damaged cells and other particulate matter. Pain and tenderness remind the patient to protect the injured area; however, the inflammatory reaction eventually becomes counterproductive. The mechanism of corticosteroid action includes a reduction of the inflammatory reaction by limiting the capillary dilatation and permeability of the vascular structures. These compounds restrict the accumulation of polymorphonuclear leukocytes and macrophages and reduce the release of vasoactive kinins. They also inhibit the release of destructive enzymes that attack the injury debris and destroy normal tissue indiscriminately. Additionally, new research suggests that corticosteroids may inhibit the release of arachidonic acid from phospholipids, thereby reducing the formation of prostaglandins, which contribute to the inflammatory process. There are no previous prospective, randomized studies that look at utilization of corticosteroids in treatment of the high ankle sprain. Only anecdotal information is available in simple case reports for treatment. There was one study looking at treatment with platelet rich plasma injection which demonstrated shorter return to play times and less long term residual pain.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Sanford Orthopedics and Sports Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 16 years or older
  • Musculoskeletal ultrasound performed which demonstrates injury pattern consistent with high ankle sprain.
  • Must sign the informed consent form and agree to meet the needs of the study
  • Clinically and ultra sound confirmed and isolated syndesmotic ligament injury or high ankle sprain without associated fracture
  • Injury occurred within the previous 7 days

Exclusion Criteria:

  • Surgical intervention required to stabilize the ankle
  • Unable to read and understand the consent form
  • Unable to meet the needs of the follow-up examinations
  • Allergic to the betamethasone
  • Current fungal infection
  • Pregnancy or currently breast feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bupivacaine hydrochloride and betamethasone sodium phosphate
When the patient has been randomized to either group, a licensed provider under the direction of the PI, will utilize the ultrasound to identify the inferior tibiofibular ligament (syndesmotic ligament). This provider that performs the injection will not be involved in any follow-up visits or return to play review. When appropriate positioning is confirmed the area will be injected with a mixture of 5 ml of 0.25 % bupivacaine hydrochloride and 2 ml of 3 mg/ml betamethasone sodium phosphate (Celestone® Soluspan®) (BTM)
Drug: bupivacaine hydrochloride and betamethasone sodium phosphate
5ml of 0.25% bupivacaine hydrochloride and 2 ml of 3mg/ml betamethasone sodium phosphate one injection into the inferior tibiofibular ligament
Other Names:
  • Marcaine, Celestone, Soluspan,
Active Comparator: bupivacaine hydrochloride
When the patient has been randomized to either group, a licensed provider under the direction of the PI, will utilize the ultrasound to identify the inferior tibiofibular ligament (syndesmotic ligament). This provider that performs the injection will not be involved in any follow-up visits or return to play review. When appropriate positioning is confirmed, the area will be injected with 5ml of bupivacaine hydrochloride.
Drug: bupivacaine hydrochloride
5ml of bupivacaine hydrochloride into the tibiofibular ligament
Other Names:
  • Marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare Between the Two Groups the Time to Return to Previous Levels of Activity
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare Patient Reported Outcomes Between the Two Groups Using the Foot and Ankle Ability Measure (FAAM) Tool.
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanford Health

Investigators

  • Principal Investigator: Bruce Piatt, MD, Orthopedic Surgeon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

September 21, 2016

Study Completion (Actual)

September 21, 2016

Study Registration Dates

First Submitted

August 23, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimated)

September 8, 2016

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SanfordHealth

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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