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Trial record 70 of 371 for:    under | North Dakota, United States

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

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ClinicalTrials.gov Identifier: NCT02892500
Recruitment Status : Terminated (Inability to enroll subjects)
First Posted : September 8, 2016
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Sanford Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ankle Injuries Drug: bupivacaine hydrochloride and betamethasone sodium phosphate Drug: bupivacaine hydrochloride Phase 2

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  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single-site, Double Blinded, Randomized Investigation of Corticosteroid Versus Placebo Injection Under Ultrasound Guidance in Patients With Syndesmotic Ligament Injury or High Ankle Sprain
Study Start Date : April 2016
Actual Primary Completion Date : September 21, 2018
Actual Study Completion Date : September 21, 2018


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 Name: 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 Name: Marcaine




Primary Outcome Measures :
  1. Compare between the two groups the time to return to previous levels of activity [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Compare patient reported outcomes between the two groups using the Foot and Ankle Ability Measure (FAAM) tool. [ Time Frame: One year ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02892500


Locations
United States, North Dakota
Sanford Orthopedics and Sports Medicine
Fargo, North Dakota, United States, 58103
Sponsors and Collaborators
Sanford Health
Investigators
Principal Investigator: Bruce Piatt, MD Orthopedic Surgeon

Publications:

Responsible Party: Sanford Health
ClinicalTrials.gov Identifier: NCT02892500     History of Changes
Other Study ID Numbers: SanfordHealth
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Wounds and Injuries
Ankle Injuries
Leg Injuries
Bupivacaine
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Respiratory System Agents