Steroid Administration for Articular Fractures of the Elbow (SAFE Trial)

NCT04738318 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 210125
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to determine if perioperative glucocorticoid administration (IV intra-operative followed by a post-operative oral taper course) improves post-operative range of motion in a patient population that has sustained an intra-articular elbow fracture(s) (radial head, proximal ulna, distal humerus, or combined) that required operative fixation.

Conditions

Elbow Fracture

Keywords

Glucocorticoid Administration

Outcome Measures

Primary Outcomes (1)

• Post-operative Range of Motion of Elbow

  Flexion, extension, pronation, supination

  Change between 2-week, 6-week, 3-month, 6-month, and final follow-up visits.

Study Arms (2)

Treatment Arm (Glucocorticoid)

EXPERIMENTAL

Patients will receive a single intraoperative dose of 10mg of intravenous dexamethasone. Following surgery, the participant will be provided with a 1) six-day oral methylprednisolone taper course.

Drug: Glucocorticoids

Control Arm (Placebo)

PLACEBO COMPARATOR

Patients will receive a single intraoperative dose of 10 mg of saline. Following surgery, the participant will be provided with a six-day placebo course.

Drug: Saline

Interventions

Glucocorticoids DRUG

Patients will receive a single intraoperative dose of 10mg of intravenous dexamethasone intraoperatively. Following surgery, the participant will be provided with a six-day oral methylprednisolone taper course.

Also known as: Dexamethasone, Methylprednisolone

Treatment Arm (Glucocorticoid)

Saline DRUG

Patients will receive a single intraoperative dose of 10 mg of saline. Following surgery, the participant will be provided with a six-day placebo course.

Control Arm (Placebo)

Eligibility Criteria

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

You may qualify if:

• All adults ≥18 years old with an isolated, intra-articular traumatic elbow fracture to be treated at Vanderbilt University Medical Center with operative intervention and a standardized post-operative rehab protocol.
• Intra-articular elbow fracture defined as:
• Distal humerus
• Proximal ulna
• Radial head fracture
• Combination fracture of two or more of the above
• Radiographs present confirming intra-articular injury

You may not qualify if:

• Patients with bilateral elbow fractures
• Patients with an altered mental status
• Pregnant
• Allergy or contra-indication to glucocorticoid administration
• Type 1 or Type 2 diabetes
• Pre-injury limitation in elbow range or motion (patient reported)
• Unable to provide consent for themselves

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (9)

• Chen HW, Liu GD, Wu LJ. Complications of treating terrible triad injury of the elbow: a systematic review. PLoS One. 2014 May 15;9(5):e97476. doi: 10.1371/journal.pone.0097476. eCollection 2014.

  PMID: 24832627 BACKGROUND

• Kodde IF, van Rijn J, van den Bekerom MP, Eygendaal D. Surgical treatment of post-traumatic elbow stiffness: a systematic review. J Shoulder Elbow Surg. 2013 Apr;22(4):574-80. doi: 10.1016/j.jse.2012.11.010. Epub 2013 Feb 1.

  PMID: 23375881 BACKGROUND

• Morrey BF, Askew LJ, Chao EY. A biomechanical study of normal functional elbow motion. J Bone Joint Surg Am. 1981 Jul;63(6):872-7.

  PMID: 7240327 BACKGROUND

• Wahl EP, Lampley AJ, Chen A, Adams SB, Nettles DL, Richard MJ. Inflammatory cytokines and matrix metalloproteinases in the synovial fluid after intra-articular elbow fracture. J Shoulder Elbow Surg. 2020 Apr;29(4):736-742. doi: 10.1016/j.jse.2019.09.024. Epub 2019 Nov 26.

  PMID: 31784384 BACKGROUND

• Desai MJ, Matson AP, Ruch DS, Leversedge FJ, Aldridge JM 3rd, Richard MJ. Perioperative Glucocorticoid Administration Improves Elbow Motion in Terrible Triad Injuries. J Hand Surg Am. 2017 Jan;42(1):41-46. doi: 10.1016/j.jhsa.2016.11.011.

  PMID: 28052827 BACKGROUND

• Kaneguchi A, Ozawa J, Yamaoka K. Anti-inflammatory Drug Dexamethasone Treatment During the Remobilization Period Improves Range of Motion in a Rat Knee Model of Joint Contracture. Inflammation. 2018 Aug;41(4):1409-1423. doi: 10.1007/s10753-018-0788-5.

  PMID: 29911276 BACKGROUND

• Wu Y, Lu X, Ma Y, Zeng Y, Bao X, Xiong H, Shen B. Perioperative multiple low-dose Dexamethasones improves postoperative clinical outcomes after Total knee arthroplasty. BMC Musculoskelet Disord. 2018 Dec 1;19(1):428. doi: 10.1186/s12891-018-2359-1.

  PMID: 30501618 BACKGROUND

• Xu H, Zhang S, Xie J, Lei Y, Cao G, Pei F. Multiple Doses of Perioperative Dexamethasone Further Improve Clinical Outcomes After Total Knee Arthroplasty: A Prospective, Randomized, Controlled Study. J Arthroplasty. 2018 Nov;33(11):3448-3454. doi: 10.1016/j.arth.2018.06.031. Epub 2018 Jul 4.

  PMID: 30033064 BACKGROUND

• Pugh DM, Wild LM, Schemitsch EH, King GJ, McKee MD. Standard surgical protocol to treat elbow dislocations with radial head and coronoid fractures. J Bone Joint Surg Am. 2004 Jun;86(6):1122-30. doi: 10.2106/00004623-200406000-00002.

  PMID: 15173283 BACKGROUND

MeSH Terms

Conditions

Elbow Fractures

Interventions

Glucocorticoids; Dexamethasone; Methylprednisolone; Sodium Chloride

Condition Hierarchy (Ancestors)

Elbow Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Prednisolone; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

The study was terminated early and converted to a non-interventional, observational study model. Of the 3 participants consented prior to termination, only 2 were randomized to a treatment arm and only 1 completed study procedures.

Results Point of Contact

• Title: Dr. Jed Maslow
• Organization: Vanderbilt University Medical Center

jed.i.maslow@vumc.org

615-936-7846

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The treating physician and patient will be blinded to the treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Orthopaedic Surgery

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 4, 2021
• Study Start: June 16, 2022
• Primary Completion: March 10, 2023
• Study Completion: March 10, 2023
• Last Updated: December 29, 2023
• Results First Posted: December 29, 2023

Record last verified: 2023-12

Locations

US (1)