Elbow FracturePhase 4SAFENCT04738318
Steroid Administration for Articular Fractures of the Elbow (SAFE Trial)
A Phase 4 study testing Glucocorticoids and Saline in people with Elbow Fracture, run by Vanderbilt University Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elbow Fracture
- What is being tested?
- Glucocorticoids and Saline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2022to 10 Mar 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
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
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.
Read the 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?
- Conditions
- Elbow Fracture
- Being tested
- Glucocorticoids, Saline
- Keywords
- Glucocorticoid Administration
- Medical subject headings
- Elbow Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucocorticoidsDrug
Also called Dexamethasone, Methylprednisolone
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.
SalineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Range of Motion of Elbow
Flexion, extension, pronation, supination
Measured: Change between 2-week, 6-week, 3-month, 6-month, and final follow-up visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start16 Jun 2022
- Primary completion10 Mar 2023
- Study completion10 Mar 2023
Why it stopped: Switched to observational study type.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Elbow FractureStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jed Maslow, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738318
- Sponsor's protocol ID
- 210125
- Acronym
- SAFE
- Status last verified
- Dec 2023
- First submitted
- 27 Jan 2021
- Last updated
- 29 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 24832627Kodde 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.
PubMed 23375881Morrey BF, Askew LJ, Chao EY. A biomechanical study of normal functional elbow motion. J Bone Joint Surg Am. 1981 Jul;63(6):872-7.
PubMed 7240327Wahl 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.
PubMed 31784384Desai 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.
PubMed 28052827Kaneguchi 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.
PubMed 29911276Wu 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.
PubMed 30501618Xu 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.
PubMed 30033064Pugh 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.
PubMed 15173283
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04738318
- Acronym / sponsor ID
- SAFE / 210125
- Conditions
- Elbow Fracture
- Keywords
- Glucocorticoid Administration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Switched to observational study type.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 4 Feb 2021 (actual)
- Results
- Posted 29 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm (Glucocorticoid) | Experimental | Drug: GlucocorticoidsPatients 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. |
| Control Arm (Placebo) | Placebo comparator | Drug: SalinePatients will receive a single intraoperative dose of 10 mg of saline. Following surgery, the participant will be provided with a six-day placebo course. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Radiographs present confirming intra-articular injury
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlucocorticoidsAlso: Dexamethasone, MethylprednisolonePatients 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. | Drug | Treatment Arm (Glucocorticoid) |
| SalinePatients 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 | Control Arm (Placebo) |
Primary outcome
Post-operative Range of Motion of Elbow
Time frame: Change between 2-week, 6-week, 3-month, 6-month, and final follow-up visits.
Flexion, extension, pronation, supination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24832627Chen 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.
- Background: PubMed 23375881Kodde 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.
- Background: PubMed 7240327Morrey BF, Askew LJ, Chao EY. A biomechanical study of normal functional elbow motion. J Bone Joint Surg Am. 1981 Jul;63(6):872-7.
- Background: PubMed 31784384Wahl 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.
- Background: PubMed 28052827Desai 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.
- Background: PubMed 29911276Kaneguchi 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.
- Background: PubMed 30501618Wu 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.
- Background: PubMed 30033064Xu 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.
- Background: PubMed 15173283Pugh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glucocorticoids and Saline in people with Elbow Fracture, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Range of Motion of Elbow (time frame: Change between 2-week, 6-week, 3-month, 6-month, and final follow-up visits.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04738318, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.