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

NCT02892500 | Terminated Phase 2 Results

• 1 other identifier: SanfordHealth
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Injuries

Outcome Measures

Primary Outcomes (1)

• Compare Between the Two Groups the Time to Return to Previous Levels of Activity

  One year

Secondary Outcomes (1)

• Compare Patient Reported Outcomes Between the Two Groups Using the Foot and Ankle Ability Measure (FAAM) Tool.

  One year

Study Arms (2)

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)

Drug: bupivacaine hydrochloride and betamethasone sodium phosphate

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.

Drug: bupivacaine hydrochloride

Interventions

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

Also known as: Marcaine, Celestone, Soluspan,

bupivacaine hydrochloride and betamethasone sodium phosphate

bupivacaine hydrochloride DRUG

5ml of bupivacaine hydrochloride into the tibiofibular ligament

Also known as: Marcaine

bupivacaine hydrochloride

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanford Health: lead

Study Sites (1)

Sanford Orthopedics and Sports Medicine

Fargo, North Dakota, 58103, United States

Location

Related Publications (8)

• 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.

  PMID: 23339895 BACKGROUND

• 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.

  PMID: 2113510 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.

  PMID: 15572325 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.

  PMID: 6642626 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.

  PMID: 11206253 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.

  PMID: 15712981 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.

  PMID: 19336613 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.

  PMID: 24938396 BACKGROUND

MeSH Terms

Conditions

Ankle Injuries

Interventions

Bupivacaine; betamethasone sodium phosphate; Betamethasone

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Christie Ellison
• Organization: Sanford Health

christie.ellison@sanfordhealth.org

605-312-6030

Study Officials

• Bruce Piatt, MD

  Orthopedic Surgeon

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: September 8, 2016
• Study Start: April 1, 2016
• Primary Completion: September 21, 2016
• Study Completion: September 21, 2016
• Last Updated: February 13, 2024
• Results First Posted: November 2, 2020

Record last verified: 2024-01

Locations

US (1)