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

NCT ID: NCT02892500

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-09-21

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.

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.

Conditions

Ankle Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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)

Group Type: EXPERIMENTAL

bupivacaine hydrochloride and betamethasone sodium phosphate

Intervention Type: DRUG

5ml of 0.25% bupivacaine hydrochloride and 2 ml of 3mg/ml betamethasone sodium phosphate one injection into the inferior tibiofibular ligament

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.

Group Type: ACTIVE_COMPARATOR

bupivacaine hydrochloride

Intervention Type: DRUG

5ml of bupivacaine hydrochloride into the tibiofibular ligament

Interventions

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

Intervention Type: DRUG

bupivacaine hydrochloride

5ml of bupivacaine hydrochloride into the tibiofibular ligament

Intervention Type: DRUG

Other Intervention Names

Marcaine, Celestone, Soluspan,; Marcaine

Eligibility 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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanford Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruce Piatt, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopedic Surgeon

Locations

Sanford Orthopedics and Sports Medicine

Fargo, North Dakota, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 23339895 (View on PubMed)

Hopkinson WJ, St Pierre P, Ryan JB, Wheeler JH. Syndesmosis sprains of the ankle. Foot Ankle. 1990 Jun;10(6):325-30. doi: 10.1177/107110079001000607.

Reference Type: BACKGROUND

PMID: 2113510 (View on PubMed)

Wright RW, Barile RJ, Surprenant DA, Matava MJ. Ankle syndesmosis sprains in national hockey league players. Am J Sports Med. 2004 Dec;32(8):1941-5. doi: 10.1177/0363546504264581.

Reference Type: BACKGROUND

PMID: 15572325 (View on PubMed)

Katznelson A, Lin E, Militiano J. Ruptures of the ligaments about the tibio-fibular syndesmosis. Injury. 1983 Nov;15(3):170-2. doi: 10.1016/0020-1383(83)90007-4.

Reference Type: BACKGROUND

PMID: 6642626 (View on PubMed)

Nussbaum ED, Hosea TM, Sieler SD, Incremona BR, Kessler DE. Prospective evaluation of syndesmotic ankle sprains without diastasis. Am J Sports Med. 2001 Jan-Feb;29(1):31-5. doi: 10.1177/03635465010290011001.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 15712981 (View on PubMed)

Mei-Dan O, Kots E, Barchilon V, Massarwe S, Nyska M, Mann G. A dynamic ultrasound examination for the diagnosis of ankle syndesmotic injury in professional athletes: a preliminary study. Am J Sports Med. 2009 May;37(5):1009-16. doi: 10.1177/0363546508331202. Epub 2009 Mar 31.

Reference Type: BACKGROUND

PMID: 19336613 (View on PubMed)

Laver L, Carmont MR, McConkey MO, Palmanovich E, Yaacobi E, Mann G, Nyska M, Kots E, Mei-Dan O. Plasma rich in growth factors (PRGF) as a treatment for high ankle sprain in elite athletes: a randomized control trial. Knee Surg Sports Traumatol Arthrosc. 2015 Nov;23(11):3383-92. doi: 10.1007/s00167-014-3119-x. Epub 2014 Jun 18.

Reference Type: BACKGROUND

PMID: 24938396 (View on PubMed)

Other Identifiers

SanfordHealth

Identifier Type: -

Identifier Source: org_study_id