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NCT03661645

Post-operative Methylprednisolone Taper Course for Orthopedic Surgery

Enrolling by Invitation
PHASE4Ages 18–95InterventionalTreatment
Emory University
~500 participants
Updated 2026-03-12 on ClinicalTrials.gov
What's tested:10 mg IV dexamethasone & 6 day oral methylprednisolone taper10 mg IV dexamethasone

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over Post Operative day (1-15), 2 weeks, 6 weeks, 12 weeks, and 1 year postoperatively
+4 more outcomes measured

Conditions

Orthopedic Surgeries

Explore related trials

Arm FractureArthroplasty of shoulderHip OsteoarthritisOsteoarthritis of kneeUpper Extremity ArthritisUpper Extremity Compressive NeuropathyUpper Extremity Tendon Pathology

Where it's being run

3 sites across 1 states
Georgia3

Study leadership

  • Michael Gottschalk, MD · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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
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

Exclusion

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.

What this trial measures

  • 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 groupPost 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 groupPost 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 groupPre 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 injuries2 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 injuries2 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).