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

Primary Purpose

Elbow Fracture

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Glucocorticoids
Saline
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Elbow Fracture focused on measuring Glucocorticoid Administration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Arm (Glucocorticoid)

Control Arm (Placebo)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Post-operative range of motion of elbow
Flexion, extension, pronation, supination

Secondary Outcome Measures

Full Information

First Posted
January 27, 2021
Last Updated
August 20, 2023
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04738318
Brief Title
Steroid Administration for Articular Fractures of the Elbow (SAFE Trial)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Switched to observational study type.
Study Start Date
June 16, 2022 (Actual)
Primary Completion Date
March 10, 2023 (Actual)
Study Completion Date
March 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elbow Fracture
Keywords
Glucocorticoid Administration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
The treating physician and patient will be blinded to the treatment assignment.
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm (Glucocorticoid)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Arm (Placebo)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Glucocorticoids
Other Intervention Name(s)
Dexamethasone, Methylprednisolone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post-operative range of motion of elbow
Description
Flexion, extension, pronation, supination
Time Frame
Change between 2-week, 6-week, 3-month, 6-month, and final follow-up visits.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24832627
Citation
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.
Results Reference
background
PubMed Identifier
23375881
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.
Results Reference
background
PubMed Identifier
7240327
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.
Results Reference
background
PubMed Identifier
31784384
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.
Results Reference
background
PubMed Identifier
28052827
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.
Results Reference
background
PubMed Identifier
29911276
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.
Results Reference
background
PubMed Identifier
30501618
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.
Results Reference
background
PubMed Identifier
30033064
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.
Results Reference
background
PubMed Identifier
15173283
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.
Results Reference
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Steroid Administration for Articular Fractures of the Elbow (SAFE Trial)

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