Orthopedic SurgeriesPhase 4NCT03661645
Post-operative Methylprednisolone Taper Course for Orthopedic Surgery
A Phase 4 study testing 10 mg IV dexamethasone & 6 day oral methylprednisolone taper and 10 mg IV dexamethasone in people with Orthopedic Surgeries, run by Emory University at 3 sites in United States.
Trial summary
The clinical trial is a prospective randomized control trial of a group of patients undergoing surgical management of common orthopedic pathologies including fractures of the upper extremity and shoulder arthroplasty; arthritis surgeries (ex. carpometacarpal arthroplasty), release of compressive neuropathies (ex. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Orthopedic Surgeries
- What is being tested?
- 10 mg IV dexamethasone & 6 day oral methylprednisolone taper and 10 mg IV dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Sep 2018to Jan 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of Emory Hand Surgeons undergoing surgery for an upper extremity fracture who are willing to participate in the study will be included in the study (Including American Orthopedic(AO) and American Orthopaedic Trauma Association (OTA) AO/OTA Classification 1, 2, and 7 +/- Type A, B, C).
- Patients of Emory Hand Surgeons undergoing Total Shoulder Arthroplasty or Reverse Shoulder Arthroplasty who are willing to participate in the study will be included in the study (Walsh Classification A-D).
- Patients of Emory Hand Surgeons undergoing surgery for upper extremity arthritis (ex. carpometacarpal arthroplasty)
- Patients of Emory Hand Surgeons undergoing release for upper extremity compressive neuropathies (ex. carpal tunnel surgery)
- Patients of Emory Hand Surgeons undergoing procedures for upper extremity tendon pathologies (ex. tendon repair)
- Patients undergoing total hip arthroplasty for osteoarthritis of the hip
Show all 9Show fewer
- Patients undergoing total knee arthroplasty for osteoarthritis of the knee
- Between the ages of 18 years and 95 years.
- Patients willing and able to provide written and informed consent
Who cannot join
- Patients with concurrent and significant injuries to other bones or organs.
- Patients with local infections.
- Patients who are minors, vulnerable subjects, or who are not willing to consent to participate in the study.
- History of alcohol or medical abuse, allergies to glucocorticoids, daily use of glucocorticoids or chronic opioid use prior to the injury (morphine, fentanyl, hydromorphone, ketobemidone, methadone, nico morphine, oxycodone, and meperidine), history of severe heart disease ( New York Heart Association (NYHA 2)), renal failure, or liver dysfunction, active peptic ulcer disease, diabetic neuropathy, rheumatoid arthritis, and neurological or psychiatric diseases, potentially influencing pain perception.
- Women who are pregnant
- Patients with pre-existing immune suppression, where further immune suppression with GCs could warrant unwarranted or unneeded risk.
- Subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Emory Clinic A, Clifton Road Clinic
Atlanta, Georgia, 30322
21 Ortho Lane
Atlanta, Georgia, 30329
Emory Healthcare Orthopaedics and Spine Center
Atlanta, Georgia, 30329
About this study
The clinical trial is a prospective randomized control trial of a group of patients undergoing surgical management of common orthopedic pathologies including fractures of the upper extremity and shoulder arthroplasty; arthritis surgeries (ex. carpometacarpal arthroplasty), release of compressive neuropathies (ex. carpal tunnel surgery), tendon procedures (ex. tendon repair), patients undergoing total hip arthroplasty for osteoarthritis of the hip or total knee arthroplasty for osteoarthritis of the knee.
Patients will be assigned randomly to one of two treatment arms: (1) single intraoperative dose of 10 mg intravenous dexamethasone (control group, IV dexamethasone is standard of care) or (2) single intraoperative dose of 10 mg intravenous dexamethasone followed with a 6-day oral methylprednisolone taper course (Active Group).
The purpose of this study is to study the efficacy of a post-operative course of glucocorticoids (GCs like Methylprednisolone) on pain, nausea and range of motion after surgical management of common orthopedic upper extremity pathologies, including fractures of the upper extremity and shoulder arthroplasty and patients undergoing total hip arthroplasty for osteoarthritis of the hip or total knee arthroplasty for osteoarthritis of the knee.
Read the detailed description
Reducing pain and improving function is of great importance in the immediate period after surgery. Many orthopaedic procedures result in fluid build-up around the surgical site which results in pain and decreased healing. Glucocorticoids are drugs that block the inflammatory process which can decrease this pain and fluid build-up. Furthermore, glucocorticoids are safe if given in low doses and for a short period of time. To help address this gap, the study intend to give patients glucocorticoids after various upper extremity orthopedic procedures; total hip arthroplasty for osteoarthritis of the hip or total knee arthroplasty for osteoarthritis of the knee, assessing their pain and range of motion post-operatively. The study hypothesize that glucocorticoids will result in less inflammation around the surgical site, leading to pain relief, greater healing ability, and improvements in range of motion of the injured joint.
The study aims to enroll 500 subjects that are assigned randomly to one of two treatment arms: (1) single intraoperative dose of 10 mg intravenous dexamethasone (control group), IV dexamethasone is standard of care) or (2) single intraoperative dose of 10 mg intravenous dexamethasone followed with a 6-day oral methylprednisolone taper course (active group). Subjects will be followed up in clinic 2, 6, and 12 weeks postoperatively that is a standard of care for upper extremity fractures, shoulder arthroplasty, total hip arthroplasty for osteoarthritis of the hip or total knee arthroplasty for osteoarthritis of the knee
- Conditions
- Orthopedic Surgeries
- Being tested
- 10 mg IV dexamethasone & 6 day oral methylprednisolone taper, 10 mg IV dexamethasone
- Keywords
- Glucocorticoids(GS), injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 mg IV dexamethasone & 6 day oral methylprednisolone taperDrug
Also called Medrol, Depo-Medrol, Solu-Medrol, A-Methapred, Decadron, Dexasone, Diodex, Hexadrol, Maxidex
Drug: 6-day oral methylprednisolone (glucocorticoid) taper course The oral methylprednisolone taper course will begin on the day of surgery and will include 24mg on day 1, 20mg on day 2, 16mg on day 3, 12mg on day 4, 8mg on day 5, and 4mg on day.
Drug:10 mg intravenous (IV) dexamethasone
10 mg IV dexamethasoneOther
Also called Decadron, Dexasone, Diodex, Hexadrol, Maxidex
Drug:10 mg intravenous (IV) dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone Treated Group | Active comparator | Subjects in this group will receive single intraoperative course of 10 mg IV dexamethasone \& 6 day oral methylprednisolone taper that is 10 mg Intravenous IV dexamethasone and 6 day oral methylprednisolone taper course Receives: Drug: 10 mg IV dexamethasone & 6 day oral methylprednisolone taper |
| Control Group | Other | Subjects in this group will receive single intraoperative dose of 10 mg IV dexamethasone; that is 10 mg Intravenous (IV) dexamethasone Receives: Other: 10 mg IV dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in post-operative pain scores using numeric verbal analogue scores (VAS-Pain) during follow up in the methylprednisolone treated group compared to the control group
Pain assessment will be assessed before performing the injection, at the time of injection, and at each subsequent follow up visit using the Visual Analog Pain Scale (VAS-pain). The pain VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. Pain will be assessed at rest and active movement of the affected joint. Cut points for VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). Normative values are not available.
Measured: Post Operative day (1-15), 2 weeks, 6 weeks, 12 weeks, and 1 year postoperatively
Change in post-operative nausea scores using numeric verbal analogue scores (VAS-Nausea) during follow up in the methylprednisolone treated group compared to the control group
The (VAS-Nausea) questionnaire is self-completed by the subject. Subject is asked to place a line perpendicular to the VAS line at the point that represents their nausea severity.Subjects will rate their nausea severity on a 10-cm visual analog scale. The scale is ranked from 0 (least severe) to 10 (most severe).
Measured: Post Operative day (1-15), 2 weeks, 6 weeks, 12 weeks, and 1 year postoperatively
Change in Range of Motion (ROM) prior to surgery and during follow up in the methylprednisolone treated group compared to the control group
ROM assessment will take place at each clinic follow up with a hand-held goniometer. . This will be done by assessing the total flexion-extension arc of the wrist, elbow, shoulder, knee, or hip; the total pronation-supination arc at the wrist; and the adduction-abduction arc of the wrist, shoulder, and hip. ROM will be assessed on the contralateral side prior to surgery.
Measured: Pre operatively, 2 weeks, 6 weeks, 12 weeks, and 1 year postoperatively
Change in postoperative Quick Disabilities of Arm, Shoulder and Hand (QuickDASH) scores during follow up in the methylprednisolone treated group compared to the control group among subjects that underwent surgical management for upper extremity injuries
The domains explored by the Quick DASH are: (1) physical arm, shoulder or hand activity problems (6 items); (2) severity of pain and tingling (2 items); (3) social activities, work, and sleep (3 items). Each item has five response options, ranging from 1, ''no difficulty or no symptom,'' to 5, ''unable to perform activity or very severe symptom.'' If at least 10 of the 11 items are completed, a score ranging from 0 (no disability) to 100 (most severe disability) can be calculated [(sum of n responses/n) - 1] x 25.the effect size and the percentage of patients reaching Minimal Clinical Important Improvement was determined.
Measured: 2 weeks, 6 weeks, 12 weeks, and 1 year postoperatively
Change in postoperative American Shoulder and Elbow Surgeons Shoulder Score (ASES) during follow up in the methylprednisolone treated group compared to the control group among subjects that underwent surgical management for upper extremity injuries
The American Shoulder and Elbow Surgeons Shoulder Score (ASES) is a mixed outcome reporting measure, applicable for use in all patients with shoulder pathology for the assessment of shoulder function. The ASES questionnaire is composed of 17 questions. The questions focus on joint pain, instability, and activities of daily living. It is a 100 point scale (Pain scale= 50 points, 10 activities of daily living = 50 points).Score range: Pain subscale 0-50 ASES points; function/disability subscale 0-50 ASES points. Total score 0-100 ASES points (0 = worse pain and functional loss/disability).
Measured: 2 weeks, 6 weeks, 12 weeks, and 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start7 Sep 2018
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthopedic SurgeriesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Model description
- Prospective, Randomized Controlled study
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Gottschalk, Emory University
- Investigators
- Michael Gottschalk, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661645
- Sponsor's protocol ID
- IRB00104310
- Status last verified
- Mar 2026
- First submitted
- 5 Sep 2018
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Wagner ER, Hussain ZB, Karzon AL, Cooke HL, Toston RJ, Hurt JT, Dawes AM, Gottschalk MB. Methylprednisolone taper is an effective addition to multimodal pain regimens after total shoulder arthroplasty: results of a randomized controlled trial: 2022 Neer Award winner. J Shoulder Elbow Surg. 2024 May;33(5):985-993. doi: 10.1016/j.jse.2023.12.016. Epub 2024 Feb 4.
PubMed 38316236
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Methylprednisolone Taper Course for Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT03661645
- Acronym / sponsor ID
- IRB00104310
- Conditions
- Orthopedic Surgeries
- Keywords
- Glucocorticoids(GS), injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 7 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The clinical trial is a prospective randomized control trial of a group of patients undergoing surgical management of common orthopedic pathologies including fractures of the upper extremity and shoulder arthroplasty; arthritis surgeries (ex. carpometacarpal arthroplasty), release of compressive neuropathies (ex. carpal tunnel surgery), tendon procedures (ex. tendon repair), patients undergoing total hip arthroplasty for osteoarthritis of the hip or total knee arthroplasty for osteoarthritis of the knee.
Patients will be assigned randomly to one of two treatment arms: (1) single intraoperative dose of 10 mg intravenous dexamethasone (control group, IV dexamethasone is standard of care) or (2) single intraoperative dose of 10 mg intravenous dexamethasone followed with a 6-day oral methylprednisolone taper course (Active Group).
The purpose of this study is to study the efficacy of a post-operative course of glucocorticoids (GCs like Methylprednisolone) on pain, nausea and range of motion after surgical management of common orthopedic upper extremity pathologies, including fractures of the upper extremity and shoulder arthroplasty and patients undergoing total hip arthroplasty for osteoarthritis of the hip or total knee arthroplasty for osteoarthritis of the knee.
Detailed description
Reducing pain and improving function is of great importance in the immediate period after surgery. Many orthopaedic procedures result in fluid build-up around the surgical site which results in pain and decreased healing. Glucocorticoids are drugs that block the inflammatory process which can decrease this pain and fluid build-up. Furthermore, glucocorticoids are safe if given in low doses and for a short period of time. To help address this gap, the study intend to give patients glucocorticoids after various upper extremity orthopedic procedures; total hip arthroplasty for osteoarthritis of the hip or total knee arthroplasty for osteoarthritis of the knee, assessing their pain and range of motion post-operatively. The study hypothesize that glucocorticoids will result in less inflammation around the surgical site, leading to pain relief, greater healing ability, and improvements in range of motion of the injured joint.
The study aims to enroll 500 subjects that are assigned randomly to one of two treatment arms: (1) single intraoperative dose of 10 mg intravenous dexamethasone (control group), IV dexamethasone is standard of care) or (2) single intraoperative dose of 10 mg intravenous dexamethasone followed with a 6-day oral methylprednisolone taper course (active group). Subjects will be followed up in clinic 2, 6, and 12 weeks postoperatively that is a standard of care for upper extremity fractures, shoulder arthroplasty, total hip arthroplasty for osteoarthritis of the hip or total knee arthroplasty for osteoarthritis of the knee
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, Randomized Controlled study
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone Treated Group | Active comparator | Drug: 10 mg IV dexamethasone & 6 day oral methylprednisolone taperSubjects in this group will receive single intraoperative course of 10 mg IV dexamethasone \& 6 day oral methylprednisolone taper that is 10 mg Intravenous IV dexamethasone and 6 day oral methylprednisolone taper course |
| Control Group | Other | Other: 10 mg IV dexamethasoneSubjects in this group will receive single intraoperative dose of 10 mg IV dexamethasone; that is 10 mg Intravenous (IV) dexamethasone |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients of Emory Hand Surgeons undergoing surgery for an upper extremity fracture who are willing to participate in the study will be included in the study (Including American Orthopedic(AO) and American Orthopaedic Trauma Association (OTA) AO/OTA Classification 1, 2, and 7 +/- Type A, B, C).
- Patients of Emory Hand Surgeons undergoing Total Shoulder Arthroplasty or Reverse Shoulder Arthroplasty who are willing to participate in the study will be included in the study (Walsh Classification A-D).
- Patients of Emory Hand Surgeons undergoing surgery for upper extremity arthritis (ex. carpometacarpal arthroplasty)
- Patients of Emory Hand Surgeons undergoing release for upper extremity compressive neuropathies (ex. carpal tunnel surgery)
- Patients of Emory Hand Surgeons undergoing procedures for upper extremity tendon pathologies (ex. tendon repair)
Key exclusion criteria (7 listed)
- Patients with concurrent and significant injuries to other bones or organs.
- Patients with local infections.
- Patients who are minors, vulnerable subjects, or who are not willing to consent to participate in the study.
- History of alcohol or medical abuse, allergies to glucocorticoids, daily use of glucocorticoids or chronic opioid use prior to the injury (morphine, fentanyl, hydromorphone, ketobemidone, methadone, nico morphine, oxycodone, and meperidine), history of severe heart disease ( New York Heart Association (NYHA 2)), renal failure, or liver dysfunction, active peptic ulcer disease, diabetic neuropathy, rheumatoid arthritis, and neurological or psychiatric diseases, potentially influencing pain perception.
- Women who are pregnant
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 |
|---|---|---|
| 10 mg IV dexamethasone & 6 day oral methylprednisolone taperAlso: Medrol, Depo-Medrol, Solu-Medrol, A-Methapred, Decadron, Dexasone, Diodex, Hexadrol, MaxidexDrug: 6-day oral methylprednisolone (glucocorticoid) taper course The oral methylprednisolone taper course will begin on the day of surgery and will include 24mg on day 1, 20mg on day 2, 16mg on day 3, 12mg on day 4, 8mg on day 5, and 4mg on day. Drug:10 mg intravenous (IV) dexamethasone | Drug | Methylprednisolone Treated Group |
| 10 mg IV dexamethasoneAlso: Decadron, Dexasone, Diodex, Hexadrol, MaxidexDrug:10 mg intravenous (IV) dexamethasone | Other | Control Group |
Primary outcome
Change in post-operative pain scores using numeric verbal analogue scores (VAS-Pain) during follow up in the methylprednisolone treated group compared to the control group
Time frame: Post Operative day (1-15), 2 weeks, 6 weeks, 12 weeks, and 1 year postoperatively
Pain assessment will be assessed before performing the injection, at the time of injection, and at each subsequent follow up visit using the Visual Analog Pain Scale (VAS-pain). The pain VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. Pain will be assessed at rest and active movement of the affected joint. Cut points for VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). Normative values are not available.
Change in post-operative nausea scores using numeric verbal analogue scores (VAS-Nausea) during follow up in the methylprednisolone treated group compared to the control group
Time frame: Post Operative day (1-15), 2 weeks, 6 weeks, 12 weeks, and 1 year postoperatively
The (VAS-Nausea) questionnaire is self-completed by the subject. Subject is asked to place a line perpendicular to the VAS line at the point that represents their nausea severity.Subjects will rate their nausea severity on a 10-cm visual analog scale. The scale is ranked from 0 (least severe) to 10 (most severe).
Change in Range of Motion (ROM) prior to surgery and during follow up in the methylprednisolone treated group compared to the control group
Time frame: Pre operatively, 2 weeks, 6 weeks, 12 weeks, and 1 year postoperatively
ROM assessment will take place at each clinic follow up with a hand-held goniometer. . This will be done by assessing the total flexion-extension arc of the wrist, elbow, shoulder, knee, or hip; the total pronation-supination arc at the wrist; and the adduction-abduction arc of the wrist, shoulder, and hip. ROM will be assessed on the contralateral side prior to surgery.
Change in postoperative Quick Disabilities of Arm, Shoulder and Hand (QuickDASH) scores during follow up in the methylprednisolone treated group compared to the control group among subjects that underwent surgical management for upper extremity injuries
Time frame: 2 weeks, 6 weeks, 12 weeks, and 1 year postoperatively
The domains explored by the Quick DASH are: (1) physical arm, shoulder or hand activity problems (6 items); (2) severity of pain and tingling (2 items); (3) social activities, work, and sleep (3 items). Each item has five response options, ranging from 1, ''no difficulty or no symptom,'' to 5, ''unable to perform activity or very severe symptom.'' If at least 10 of the 11 items are completed, a score ranging from 0 (no disability) to 100 (most severe disability) can be calculated [(sum of n responses/n) - 1] x 25.the effect size and the percentage of patients reaching Minimal Clinical Important Improvement was determined.
Change in postoperative American Shoulder and Elbow Surgeons Shoulder Score (ASES) during follow up in the methylprednisolone treated group compared to the control group among subjects that underwent surgical management for upper extremity injuries
Time frame: 2 weeks, 6 weeks, 12 weeks, and 1 year postoperatively
The American Shoulder and Elbow Surgeons Shoulder Score (ASES) is a mixed outcome reporting measure, applicable for use in all patients with shoulder pathology for the assessment of shoulder function. The ASES questionnaire is composed of 17 questions. The questions focus on joint pain, instability, and activities of daily living. It is a 100 point scale (Pain scale= 50 points, 10 activities of daily living = 50 points).Score range: Pain subscale 0-50 ASES points; function/disability subscale 0-50 ASES points. Total score 0-100 ASES points (0 = worse pain and functional loss/disability).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Derived from this study: PubMed 38316236Wagner ER, Hussain ZB, Karzon AL, Cooke HL, Toston RJ, Hurt JT, Dawes AM, Gottschalk MB. Methylprednisolone taper is an effective addition to multimodal pain regimens after total shoulder arthroplasty: results of a randomized controlled trial: 2022 Neer Award winner. J Shoulder Elbow Surg. 2024 May;33(5):985-993. doi: 10.1016/j.jse.2023.12.016. Epub 2024 Feb 4.
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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.
Michael Gottschalk, MD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 10 mg IV dexamethasone & 6 day oral methylprednisolone taper and 10 mg IV dexamethasone in people with Orthopedic Surgeries, run by Emory University at 3 sites 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 9 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: enrolling by invitation, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in post-operative pain scores using numeric verbal analogue scores (VAS-Pain) during follow up in the methylprednisolone treated group compared to the control group (time frame: Post Operative day (1-15), 2 weeks, 6 weeks, 12 weeks, and 1 year postoperatively). The study lists 5 primary outcomes in all. 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 NCT03661645, which also lists 1 linked publication.
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 12 Mar 2026.