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Post-operative Methylprednisolone Taper Course for Orthopedic Surgery

StatusEnrolling by Invitation
PhasePhase 4
Started2018-09-07
View on ClinicalTrials.gov ↗

Amendment history

2026-03-10
Study Status, IPDSharing v10
Re-verified, no change to tracked fields
2025-02-22
Study Status, Study Description, Study Design, Outcome Measures, Contacts/Locations, IPDSharing v9
Primary completion date2025-01→2029-01
Completion date2025-01→2029-01
Enrollment target1000→500
Study description-1 characters
[...] ge of motion of the injured joint. The study aims to enroll 1000500 subjects that are assigned randomly to one of two treatment [...]
Study sites3 entries, revised
1221 ExecutiveOrtho Park DriveLane
2024-02-14
Study Status v8
Re-verified, no change to tracked fields
2023-02-08
Study Status, Outcome Measures v7
Primary completion date2023-01→2025-01
Completion date2023-04→2025-01
Secondary endpoints-1,687 characters
Change in post operative Patient-Rated Wrist Evaluation (PRWE) scores during follow up in the methylprednisolone treated group compared to the control group among subjects that underwent surgical management for upper extremity injuries Change in postoperative American Shoulder and Elbow Surgeons Sho [...]
Primary endpoints3 to 5 entries
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 Change in postoperative Quick Disabilities of Arm, [...]
2022-02-25
Study Status, Study Description, Eligibility v6
Eligibility criteria+353 characters
[...] y 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 up [...] Patients undergoing total hip arthroplasty for osteoarthriti [...]
Show 5 earlier versions
2021-02-15
Study Status v5
Primary completion date2021-01→2023-01
Completion date2021-01→2023-04
2020-08-31
Suspended→Enrolling by Invitation Study Status v4
Trial statusSuspended→Enrolling by Invitation
Reason stoppedEnrollment and study activities are temporarily suspended due to COVID-19.→not stated
2020-05-12
Recruiting→Suspended Study Status, Contacts/Locations v3
Trial statusRecruiting→Suspended
Reason stoppednot stated→Enrollment and study activities are temporarily suspended due to COVID-19.
Study sitesdetails revised at 3 of 3 sites
2019-10-08
Study Status, Outcome Measures v2
Secondary endpoints8 entries, revised
Change in postoperativeEuroQol HHS5 Dimensions score (EQ-5D) during follow up in the methylprednisolone treated group co [...] trol group among subjects that underwent surgical management for total hip arthroplasty
2018-09-14
Not Yet Recruiting→Recruiting Study Status, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2018-09→confirmed 2018-09-07
Secondary endpointsdetails revised at 1 of 8 entries
Study sitesdetails revised at 3 of 3 sites
2018-09-05
Original filing
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.
Trial Details
NCT Number NCT03661645
Lead Sponsor Emory University
Conditions Orthopedic Surgeries
Enrollment 500 participants
Start Date 2018-09-07
Primary Completion 2029-01 (estimated)
Study Completion 2029-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-12