- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05859269
Methylprednisolone Taper, Lower Extremity
Methylprednisolone Taper After Total Knee Replacement: A Prospective Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Ajay Premkumar, MD
- Phone Number: (404) 778-3350
- Email: ajay.premkumar@emory.edu
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30329
- Not yet recruiting
- Emory Musculoskeletal Institute
-
Contact:
- Ajay Premkumar, MD
- Phone Number: 404-778-3350
- Email: ajay.premkumar@emory.edu
-
Tucker, Georgia, United States, 30084
- Recruiting
- Emory University Orthopaedics & Spine Hospital
-
Contact:
- Ajay Premkumar, MD
- Phone Number: 404-778-3350
- Email: ajay.premkumar@emory.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients undergoing primary total knee arthroplasty for osteoarthritis of the knee.
- Patients of the ages of 18 and 95 years.
Exclusion Criteria:
- Patients with concurrent and significant injuries to other bones or organs.
- Minors unable to consent for participation in the study.
- Subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures.
- Patients with pre-existing immune suppression, where further immune suppression with glucocorticoids could warrant unwarranted or unneeded risk.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Group: Medrol Dose
The perioperative Medrol dose treatment will consist of a course that lasts six days, with 24 milligrams administered on the first day, 20 milligrams on the second day, 60 milligrams on the third day, 12 milligrams on the fourth day, 8 milligrams on the fifth day, and 4 milligrams on the sixth day.
Patients will then be followed up at the clinic for six weeks following their procedure to allow for clinical evaluation and to measure outcome variables.
|
Patients will receive a single intraoperative dose of 10 mg intravenous dexamethasone followed with a 6-day oral methylprednisolone taper course. Patients will also receive a standardized multimodal postoperative pain management regimen which includes nonsteroidal anti-inflammatory medication (e.g., NSAIDs) and opioid pain medications, both in the hospital and at home as part of standard care. |
Active Comparator: Control Group: Standard of Care
Patients in this group will receive a single intraoperative dose of 10 mg intravenous dexamethasone (control group, IV dexamethasone is standard of care).
|
Patients will receive a single intraoperative dose of 10 mg intravenous dexamethasone (control group, IV dexamethasone is standard of care). Patients will also receive a standardized multimodal postoperative pain management regimen which includes nonsteroidal anti-inflammatory medication (e.g., NSAIDs) and opioid pain medications, both in the hospital and at home as part of standard care. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Pain Score during Follow up period
Time Frame: Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
|
A pain assessment will be assessed at each post-operative visit via the Visual Analog Pain Scale (VAS-pain), which is ranked from 0 (no pain) to 10 (highest amount of pain). Pain will be assessed at rest and during active movement of extremity. Patients will also be asked to fill out the VAS-pain score each day until post-op day 7. |
Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
|
Changes in Nausea score during Follow Up Period
Time Frame: Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
|
: A nausea assessment will be assessed at each post-operative visit via the Visual Analog Nausea Scale (VAS-nausea), which is ranked from 0 (no nausea) to 10 (highest amount of nausea).
Patients will be asked to fill out the VAS-nausea each day until post-operative day 7. Patients will also be monitored for post-operative vomiting.
|
Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the postoperative range of motion following total knee arthroplasty (TKA)
Time Frame: Immediately before the surgery, Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
|
Range of motion (ROM) assessment will take place at each clinic followed up with a hand-held goniometer.
This will be done by assessing the total flexion-extension arc of the knee.
ROM will be assessed as well in the preoperative holding area prior to surgery
|
Immediately before the surgery, Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
|
Changes in post operative knee function utilizing Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
|
The Patient-Related Knee Evaluation surveys.
They have been used / validated in several studies and have a strong correlation with other scores.
The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
These scores (and the KOOS, which the attending physician performs at follow up clinics after TKA) will be administered at each post-operative follow up.
|
Day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
|
Compare patient satisfaction with acute postoperative pain control
Time Frame: Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
|
Patients will be asked about their pain control and satisfaction with the procedure and whether it meets or exceeds their expectations.
The rating scale is much worse than expected, worse than expected, as expected, better than expected, or much better than expected.
|
Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
|
Compare the postoperative opiate consumption measured as the number of tablets taken
Time Frame: Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
|
Narcotic usage will be monitored, and the patient will be asked to count the amount of pain pills taken daily and this will be reported as part of the pain diary for the first 7 days.
|
Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ajay Premkumar, MD, Emory University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Arthritis
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
Other Study ID Numbers
- STUDY00005985
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Knee Arthritis
-
NHS LothianNot yet recruitingOsteo Arthritis Knee | Arthropathy of Knee | Arthritis KneeUnited Kingdom
-
Zimmer BiometEnrolling by invitationOsteo Arthritis Knee | Knee Arthritis | Total Knee Arthroplasty | Total Knee Replacement | Monitoring Orthopedic DevicesUnited States
-
Loma Linda UniversityWithdrawnKnee Arthroscopy | Arthritis of Knee | Normal Knee
-
CorinActive, not recruitingOsteo Arthritis Knee | Total Knee Arthroplasty | Total Knee Replacement | Knee DiseaseFrance
-
CorinRecruitingOsteo Arthritis Knee | Total Knee Arthroplasty | Total Knee Replacement | Knee DiseaseFrance
-
CorinActive, not recruitingOsteo Arthritis Knee | Total Knee Arthroplasty | Total Knee Replacement | Knee DiseaseFrance
-
Medical University of WarsawCompletedOsteo Arthritis Knee | Knee Arthritis | Knee Pain ChronicPoland
-
Rehasport ClinicUnknownJoint Diseases | Knee Osteoarthritis | Osteo Arthritis Knee | Knee Arthritis | Knee Pain Chronic | Knee Pain Swelling | Knee DiseasePoland
-
Science and Research Centre KoperSlovenian Research AgencyCompletedOsteo Arthritis Knee | Knee ArthroplastySlovenia
-
The University of Tennessee, KnoxvilleMicroPort Orthopedics Inc.Not yet recruitingOsteo Arthritis Knee | Knee Injuries | Total Knee Arthroplasty | Knee ImlantUnited States
Clinical Trials on Methylprednisolone
-
Rennes University HospitalUnknownMultiple Sclerosis, Relapsing-RemittingFrance
-
Assistance Publique - Hôpitaux de ParisCompleted
-
Chang Gung Memorial HospitalRecruitingMucocutaneous Lymph Node SyndromeTaiwan
-
Fred LublinPfizer; National Multiple Sclerosis SocietyTerminatedMultiple SclerosisUnited States
-
Universidad Nacional Autonoma de MexicoInstituto Nacional de Neurología y NeurocirugíaEnrolling by invitationMethylprednisolone | Intranasal Administration | Patients With an Active Multiple Sclerosis RelapseMexico
-
LEO PharmaBayerCompleted
-
Assiut UniversityCompleted
-
University of Colorado, DenverUniversity of Pennsylvania; MallinckrodtTerminatedMultiple SclerosisUnited States
-
Fundação de Medicina Tropical Dr. Heitor Vieira...CompletedSARS-CoV Infection | Severe Acute Respiratory Syndrome (SARS) PneumoniaBrazil
-
Peking University People's HospitalBeijing HospitalUnknownImmune Thrombocytopenia