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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bupivacaine hydrochloride and betamethasone sodium phosphate | Experimental | 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) |
|
| bupivacaine hydrochloride | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bupivacaine hydrochloride and betamethasone sodium phosphate | Drug | 5ml of 0.25% bupivacaine hydrochloride and 2 ml of 3mg/ml betamethasone sodium phosphate one injection into the inferior tibiofibular ligament |
| Measure | Description | Time Frame |
|---|---|---|
| Compare Between the Two Groups the Time to Return to Previous Levels of Activity | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Compare Patient Reported Outcomes Between the Two Groups Using the Foot and Ankle Ability Measure (FAAM) Tool. | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Piatt, MD | Orthopedic Surgeon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanford Orthopedics and Sports Medicine | Fargo | North Dakota | 58103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23339895 | Background | Hunt KJ, George E, Harris AH, Dragoo JL. Epidemiology of syndesmosis injuries in intercollegiate football: incidence and risk factors from National Collegiate Athletic Association injury surveillance system data from 2004-2005 to 2008-2009. Clin J Sport Med. 2013 Jul;23(4):278-82. doi: 10.1097/JSM.0b013e31827ee829. | |
| 2113510 | Background |
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No participants were randomized or treated during the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| bupivacaine hydrochloride | Drug | 5ml of bupivacaine hydrochloride into the tibiofibular ligament |
|
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| 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. |
| 15572325 | Background | 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. |
| 6642626 | Background | 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. |
| 11206253 | Background | 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. |
| 15712981 | Background | Cole BJ, Schumacher HR Jr. Injectable corticosteroids in modern practice. J Am Acad Orthop Surg. 2005 Jan-Feb;13(1):37-46. doi: 10.5435/00124635-200501000-00006. |
| 19336613 | Background | 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. |
| 24938396 | Background | 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. |
| FG001 | 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. bupivacaine hydrochloride: 5ml of bupivacaine hydrochloride into the tibiofibular ligament |
| COMPLETED |
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| NOT COMPLETED |
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No participants were randomized or treated therefore no baseline characteristics were collected for this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) 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 |
| BG001 | 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. bupivacaine hydrochloride: 5ml of bupivacaine hydrochloride into the tibiofibular ligament |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
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| Age, Continuous | |||||||||||||||||||||||||||||||
| Sex: Female, Male |
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| Ethnicity (NIH/OMB) |
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| Race (NIH/OMB) |
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| Region of Enrollment | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Compare Between the Two Groups the Time to Return to Previous Levels of Activity | No participants randomized and treated. | Posted | One year |
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| Secondary | Compare Patient Reported Outcomes Between the Two Groups Using the Foot and Ankle Ability Measure (FAAM) Tool. | No participants randomized or treated. | Posted | One year |
|
participant withdrew before randomization and prior to any assessment of adverse events.
No participants treated on this trial therefore no adverse events were collected on the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | 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. bupivacaine hydrochloride: 5ml of bupivacaine hydrochloride into the tibiofibular ligament | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christie Ellison | Sanford Health | 605-312-6030 | christie.ellison@sanfordhealth.org |
| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| C028994 | betamethasone sodium phosphate |
| D001623 | Betamethasone |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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