drugset / Trial / NCT03661645

Post-operative Methylprednisolone Taper Course for Orthopedic Surgery

NCT03661645 ↗

Phase 4 Enrolling by invitation 500 enrolled Emory University
RandomizedParallel-groupOpen-labelTreatment

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. 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.

Timeline

Start
2018-09-07
Primary completion
2029-01
Completion
2029-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Methylprednisolone Other / unclassified 24 mg —
Comparator Dexamethasone Small molecule 10 mg Intravenous

Indications

No indication recorded.