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

Elbow Fracture Clinical Trial

— SAFE  

Official title:

Steroid Administration for Articular Fractures of the Elbow (SAFE Trial): A Randomized, Controlled Trial of Perioperative Glucocorticoids During Treatment of Intraarticular Elbow Fractures

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04738318
• Other study ID #: 210125
• Status: Terminated
• Phase: Phase 4
• Start date: June 16, 2022
• Est. completion date: March 10, 2023

Study information

• Verified date: December 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Elbow fractures are complex injuries that often involve the articular surface, are in close proximity to critical neurovascular structures, and are prone to post-operative complications. Complications following treatment of intra-articular elbow pathology can affect over 50% of patients and up to 30% of all patients will require a re-operation. One of the most common complications is joint stiffness.1 When a flexion arc of motion is diminished to less than 100 degrees, a flexion contracture is present greater than 30 degrees, or forearm rotation is less than 100 degrees, functional limitations are frequently present and further treatment may be recommended.2,3 In fact, contracture release may be required in 12-20% of patients after intra-articular elbow fractures and carries a relatively high complication rate when performed.

The relationship of post-traumatic elbow contracture to intra-articular fractures is well established and can caused by extrinsic factors such as heterotopic ossification (HO), fibrosis and capsular thickening, or by intrinsic factors such as failure of nonunion, malunion, arthrosis, or loose bodies.2,4 Recent studies analyzing the acute phase synovial fluid cytokine profile after an intra-articular elbow fracture have shown proinflammatory and catabolic factors in high concentrations that can lead to contracture through myofibroblast differentiation and proliferation.4 Furthermore, HO can limit range of motion in up to 40% of fractures and may also result from prolonged inflammation with elevated IL-1β and TNF-α levels.

The 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.

Primary Study Questions

1. For adult patients (>18yo) who sustain intra-articular elbow fractures (radial head, proximal ulna, distal humerus, or combined) that undergo operative fixation, does perioperative glucocorticoid administration (IV intra-operative followed by a post-operative oral taper course) improve post-operative range of motion (flexion/extension and pronation/supination) compared to a placebo?

Secondary Study Questions

2. Is perioperative glucocorticoid administration more effective in improving range of motion for certain intra-operative elbow fractures or depending on the mechanism of injury (subgroup comparison based on fracture type and high-energy or low-energy injuries)?

3. Do patients that receive perioperative glucocorticoids have a higher surgical site infection rate?

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 10, 2023
• Est. primary completion date: March 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Related Conditions & MeSH terms

• Elbow Fracture
• Elbow Fractures
• Fractures, Bone
• Intra-Articular Fractures

Intervention

Drug:
• Glucocorticoids
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.
• Saline
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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.